GSK Medicine: Study No.: Title: Rationale: before initiation of treatment, every 4-6 weeks during treatment
|
|
- Darrell White
- 5 years ago
- Views:
Transcription
1 GSK Medicine: Lapatinib Study No.: WWE115270/WEUKSTV4275 Title: Assessment of Physician Compliance to Recommend Liver Function Test (LFT) Monitoring for Lapatinib Patients Rationale: Lapatinib (Tykerb ) is a dual TKI inhibitor, and in combination with capecitabine (Xeloda) or letrozole, is approved for the treatment of hormone-receptor-positive metastatic breast cancer with HER2 over-expression. On July 9, 2008, following a review of the Lapatinib clinical program, Tykerb Prescribing Information (label) was updated (Version 4) to include a boxed warning that reads, Liver function tests (transaminases, bilirubin, and alkaline phosphatase) should be monitored before initiation of treatment, every 4-6 weeks during treatment, and as clinically indicated. If changes in liver function are severe, therapy with Tykerb should be discontinued and patients should not be retreated with Tykerb. For patient safety, it is of interest to know the extent to which providers are adherent with these guidelines for hepatic monitoring of lapatinib users as well as the rates of safety events in the target population. Objectives: The study aimed to 1) determine if physicians conduct liver function testing (LFT) prior to prescribing lapatinib (baseline), 2) describe the prevalence of LFT elevations at baseline, 3) determine if physicians conduct LFTs at regular intervals during lapatinib exposure, 4) describe the incidence of LFT elevations during lapatinib exposure and 5) determine if physicians withdraw lapatinib, and do not retreat, among patients who demonstrate severe liver enzyme elevations while exposed. Study aims 1, 3 and 5 were tested in the (prior to boxed warning) and (after boxed warning) periods to determine physician adherence to the guidelines changed as a result of the warning. Indication: Cancer Study Investigators/Centers: US Oncology Electronic Medical Records (EMR) database Research Methods: Data Source: US Oncology iknowmed electronic medical records database. The US Oncology network includes community cancer practices and cancer centers (including 90+ radiation oncology facilities) in 39 US states and comprises more than 850,000 patients or 12% of the US cancer population. Geographic dispersion is good, with all regions of the country receiving some coverage of the system. Due to the severity of the disease, longitudinality of care is fairly high for breast cancer and these patients have a fairly low level (typically <20%) of loss to follow-up. Study Design: Retrospective cohort study Study Population: This study included 396 female metastatic breast cancer patients (age >19 years) with a documented order/prescription for lapatinib from January 1, 2007 December 31, 2009 and who received care at an oncology practice utilizing the full US Oncology EMR capabilities. All included patients had at least one documented LFT test in their entire EMR to ensure that laboratory tests were captured. Patients were excluded if they participated in a clinical trial, received care for another cancer during the study period, or received lapatinib in an adjuvant or neoadjuvant setting. Study Exposures, Outcomes: The exposure was lapatinib oral medication. The index date was the date of initiation of lapatinib, and the (pre- and post-label) exposure period was defined as the index date through end of study period as follows: Pre Label : Initiated lapatinib between January 1, 2007 and December 31, Follow-up time for this group continued until June 30, 2008 to allow these patients to have at least six months of followup time prior to the label change. Post Label : Initiated lapatinib between July 9, 2008 and December 31, Follow-up time for this group continued until June 30, 2010 to allow these patients to have at least six month of follow-up. Patients that initiated lapatinib between January 1, 2008 and July 8, 2008 were not included since it was not possible for them to have a complete six months of follow-up before the label change went into effect. 1
2 Treatment duration for each prescription was determined as the standardized quantity dispensed divided by the standardized dose, and the time interval (i.e. gaps) between consecutive prescriptions was calculated as the start date of the current prescription minus the last date of the preceding prescription. A gap of >60 days was considered a drug interruption. For patients with complete or temporary (i.e. resume after interruption) discontinuation, the last administration date of lapatinib that precedes the interruption was used as the discontinuation date. The outcomes for the five objectives were: 1) Proportion of patients that received LFTs within 30 days prior to (and including) the day lapatinib was initiated. The LFTs considered were alanine transaminase (ALT), aspartate transaminase (AST), alkaline phosphatase (ALP) and total bilirubin (BILI). 2) Prevalence of LFT elevations within 30 days prior to (and including) the day of lapatinib initiation. LFT elevations were defined as an occurrence of an elevation greater than or equal to a defined upper limit of normal (ULN) threshold value for each type of LFT during the baseline periods of 30 days prior to (and including) the index date. Multiple increasingly severe ULN thresholds were explored. 3) Proportion of patients that had LFTs performed routinely (at least every 6 weeks) while exposed to lapatinib. 4) Cumulative incidence (%) and incidence rate (IR) of LFT elevation for each type of LFT during lapatinib exposure follow-up. Multiple increasingly severe ULN thresholds were explored, including selected combinations of tests that identifies potentially significant liver injury, including ALT>3x ULN + BILI>2x ULN and possible Hy s Law combination (ALT or AST>3x ULN + ALP<2x ULN + BILI>2x ULN). 5) Proportion of patients with severe LFT elevations that have lapatinib discontinued within 30 days of elevation. Severe elevation was defined as a) ALT>8x ULN or b) possible Hy s Law combination. Data Analysis Methods: All individuals were categorized into Pre-Label or group. A Chi-square test for categorical data or t-tests / Kruskul-Wallis for continuous variables were conducted to determine if there were any statistically significant differences in patient demographics, and clinical and treatment characteristics, by pre- and post-label status. Total exposure time to lapatinib, by pre- and post-label status, was also calculated. All analyses were stratified by pre- and post-label status. Wider baseline time periods and discontinuation periods, including 60 and 90 days, were explored; however, only analyses using the 30-day timeframe are presented, as it is the most relevant, and furthermore, the findings were consistent across the different periods. 1) Frequency and proportion of patients tested for LFTs within 30 days prior to and including the index date were calculated among those receiving lapatinib. Chi-square test was used to compare proportions across preand post-label groups. 2) Prevalence proportions of LFT elevations at various threshold levels within 30 days prior to the index date was calculated as the number of patients who had an LFT elevation during the baseline time period that was greater or equal to a defined ULN threshold value for each type of LFT divided by the total number of patients tested for that LFT within that time period x 100%. 3) Frequency and proportion that were tested at least once during each 6 week interval post index date among those with at least one exposure day within that 6-week time period. 4) Incidence of LFT elevation while exposed to lapatinib include: a) Cumulative incidence was calculated as the number of patients who reached an LFT elevation during the exposure period that was greater than or equal to a defined ULN threshold for each LFT (or combination) divided by the total number of patients with at least one follow-up LFT. b) Incidence rate was similarly calculated, except the denominator was the sum of person-time for all patients with at least one follow-up LFT. Person-time was defined from the index date until either the date the patient reached threshold while exposed or the date of last visit during which LFT was conducted while exposed to lapatinib, and was expressed per 1000 person-months (PM). 5) Frequency and proportion of patients that experienced a severe LFT elevation, and among those with severe 2
3 elevation, the frequency and percentage that have temporary or complete discontinuation of lapatinib in the 30 days following the elevation. Limitations: Exposure assessment The method of defining exposure period using prescription information only (supply in days) may overestimate true exposure if ordered prescriptions are not filled or taken by the patient (we have no indication of compliance with taking the medication). Alternatively, the exposure period may be under-estimated if a lapatinib refill is not documented in the EMR. Brief rests from lapatinib are difficult to capture when using prescription information only. If patients were directed to stop taking lapatinib for a brief time in the middle of a cycle of medication, they will appear to still be using the drug and considered as exposed. Similarly, an exact date for drug cessation is difficult to measure when using prescription information only. While a patient may in reality discontinue lapatinib at any point during a particular cycle, we will use the final date of the patient s final cycle as the discontinuation date. For patients with multiple lapatinib exposure periods throughout follow-up, we assessed the frequency of testing and incidence of LFT elevations only during the first exposure period. While this created a more homogenous new users population, it does decrease the overall length of follow-up exposure time evaluated. Though we excluded patients that initiated lapatinib between January 1, 2008 and July 8, 2008 since these months represent a time of transition while GSK finalized the label change wording and initiated communication activities (such as Dear Doctor letters) to educate physicians about the impending label change, patients initiating lapatinib very late in the pre-label period may contribute some follow-up time after their treating physician began to learn about the new LFT recommendations. Overall, this is likely to be a small proportion of the overall pre-label group. Outcome assessment Any liver function tests occurring outside of the US Oncology participating clinics and cancer centers were not captured in this study. For example, patients who experienced a mid to high level elevation may be referred to hepatologists for follow-up. As well, testing performed as part of in-patient hospital care would not be included. The inability to observe person time after hepatologist referral or during hospitalization may cause some underestimation in the incidence rate, especially of elevations at higher ULN thresholds. Missing ULN values for lab data occurred in about 4% of patients, however this was rectified in all cases by using the average ULN of overall labs as a referent. Study Results for LFT analysis Demographics/Baseline Characteristics: A total of 396 female metastatic breast cancer patients: 128 (32%) pre-label and 268 (68%) post-label with a median age at diagnosis of 56.4 years. Nine percent of patients who received lapatinib were HER2-negative, and 14% were missing HER2 status. The only clinical characteristic that differed significantly between the two groups was stage at initial diagnosis, with more post-label patients initially diagnosed with Stage IV cancer than pre-label patients (38% vs. 30%, respectively). Although not statistically significant, there was a trend towards physicians using lapatinib earlier in the metastatic experience, with 17% of post-label vs. 8% of pre-label patients receiving lapatinib as part of their 1 st line metastatic regimen. patients had longer median lapatinib exposure time than post-label patients (73 days vs. 53 days). Furthermore, 28% of pre-label patients compared to 38% of post-label patients were exposed to lapatinib for <6 weeks. Results of Objective 1: Determine if physicians perform LFTs prior to prescribing lapatinib (baseline) patients were statistically significantly more likely than pre-label patients to be tested within 30 days prior to initiating lapatinib (82% vs 63%) (Table 1). 3
4 Table 1. Proportion of patients tested within 30 days prior to initiating lapatinib (index date) LFT Labs (n=128) (n=268) p-value ALT (U/L) 63% 81% <.0001 AST (U/L) 64% 82% ALP (U/L) 63% 82% <.0001 BILI (mg/dl) 63% 82% <.0001 Results of Objective 2: Describe prevalence of LFT elevations at baseline The prevalence of LFT elevation was extremely rare, with no pre-label patients and only 4(1.8%) post-label patients having an ALT>3x ULN (Table 2). One post-label patient had a severe ALT elevation above 8x ULN. Table 2. Prevalence of liver function elevations within 30 days prior to index date Elevated LFT n (%) (95% CI) n (%) (95% CI) ALT > 3x ULN 0-4 (1.8%) 0.5%-4.6% ALT > 5x ULN 0-2 (0.9%) 0.1%-3.3% ALT > 8x ULN* 0-1 (0.5%) 0.0%-2.5% * This threshold was used to define severe elevation Results of Objective 3: Determine if physicians perform LFTs routinely after prescribing lapatinib The frequency of screening in the initial 6-week exposure period was high, with about 68% of pre-label patients and 81% of post-label patients tested (Table 3). Table 3. Proportion* of patients tested at least once for ALT during each 6 week interval after lapatinib prescription 6-wk exposure time interval after start of lapatinib prescription 0 to <6 weeks 68% 81% 6 to <12 weeks 73% 81% 12 to <18 weeks 73% 82% 18 to <24 weeks 62% 83% 24 to <30 weeks 63% 88% 30 to <36 weeks 61% 86% 36 to <42 weeks 82% 93% 42 to <48 weeks 86% 89% 48+ weeks 100% 88% * Identical pattern for other LFTs: AST, ALP, and BILI Results of Objective 4: Describe cumulative incidence and incidence rate of LFT elevations among lapatinib users Across all thresholds, the cumulative incidence and incidence rates were approximately similar between pre- and postlabel groups, including severe elevation classified as ALT>8x ULN (Table 4). However, the post-label group had a higher rate of the ALT>3x ULN plus BILI>2x ULN combination (2.3% vs. 1.1%) and a lower rate of possible Hy s Law combination (0.5% vs. 2.1%). Table 4. Cumulative incidence and incidence rate of LFT elevations while exposed to lapatinib (among patients with at least one test during follow-up) Elevated LFT n (%) IR a (95% CI) n (%) IR a (95% CI) ALT > 3x ULN 3 (3.2%) 8.0 (0.2, 2.3) 9 (4.1%) 12.5 (5.7, 23.8) ALT > 5x ULN 2 (2.1%) 5.3 (0.06, 1.9) 4 (1.8%) 5.5 (1.5, 14.1) ALT > 8x ULN* 0-1 (0.5%) 1.4 (0.03, 7.7) Possible Hy s Law combination b * 2 (2.1%) 5.1 (0.6, 18.5) 1 (0.5%) 1.4 (0.03, 7.7) 4
5 Other LFT combination c 1 (1.1%) 2.6 (0.1, 14.7) 5 (2.3%) 6.9 (2.2, 16.0) a Incidence rate per 1000 person-months b Hy s Law combination: AST or ALT 3x ULN + BILI 2x ULN + ALP<2x ULN c Other LFT combination: ALT>3x ULN + BILI>2x ULN * These thresholds were used to define severe elevations Results of Objective 5: Describe patients that experienced severe LFT elevations during lapatinib exposure and the proportion that have lapatinib discontinued During follow-up, only 4 patients experienced severe LFT elevation: 2 pre-label patients temporarily discontinued lapatinib within 30 days of severe elevation but resumed at a later date and 2 post-label patients with complete discontinuation within 30 days of elevation. Due to small numbers, no statistical testing of differences was conducted. Conclusion: This study provides real world evidence that physician adherence to the guidelines for conducting LFTs prior to prescribing lapatinib, and routinely during lapatinib exposure, improved after the addition of detailed guidance on liver function testing to the Prescribing Information. The post-label group was statistically significantly more likely to be tested within 30 days prior to the initiation of lapatinib than the pre-label group (81-82% vs %), and the fairly high level of testing overall among the two groups suggests that LFT testing may be an integral part of routine oncology care protocols. Likewise, when examining the occurrence of testing within each six week interval after the index date, the frequency of regular testing was higher among postlabel patients compared to pre-label levels, regardless of the length of exposure. Further, the frequency of testing did not diminish substantially with long lapatinib exposure times, again, suggesting that routine screening is likely a routine part of oncology care. With only four patients experiencing severe LFT elevations in this population, it is not possible to draw firm conclusions about whether the Prescribing Information guidance to permanently discontinue lapatinib when severe elevations occur were as closely followed. Also, we cannot be certain that the subsequent discontinuation was due solely to LFT elevation, since detailed information on the reason for discontinuation was not collected. The potential role of other factors may have influenced physician behaviors. Firstly, clinical difference between pre- and post-label groups may play a role. For example, post-label patients were more likely to be diagnosed with Stage IV disease and it is possible that physicians are more diligent about testing patients at advanced stages of the disease. However, stage did not appear as an independent predictor of testing before or during lapatinib use. The presence of liver metastases or liver co-morbidities may also be markers for more frequent testing, however the two groups did not differ with regard to the frequency of these events, and again, they were not significant independent predictors of testing. Secondly, the uptake of tyrosine kinase inhibitors in cancer care was increasing during the study period and information about the efficacy and safety of these drugs was becoming widespread in the literature and at professional congresses. Therefore, physicians may have learned about hepatic related side effects of lapatinib, or other drugs in the class, through these learning opportunities. Despite some limitations in exposure and outcome assessments, this study has several strengths including the use of a large, population based data source of nearly 400 lapatinib users, which allows for the assessment of compliance to LFT testing in the real world, community practice setting. An EMR database can be ideal for this type of study and this specific EMR had known comprehensiveness that resulted in a high capture of relevant clinical and laboratory data. As a cancer specific database, the US Oncology database also allows for the creation of a demographic and cancer profile of real world lapatinib users. This data was useful in determining if any key characteristics are associated with the various compliance steps being evaluated in this study. The pre-label/post-label study design utilized for this study provides an opportunity to assess the impact of inclusion of detailed LFT monitoring recommendations on physician behavior. 5
GSK Medicine: Study Number: Title: Rationale: Study Period: Objectives: Indication: Study Investigators/Centers: Research Methods: Data Source
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
More informationGSK Medicine: Study Number: Title: Rationale: Study Period: Objectives: Analysis 1 Analysis 2 Analysis 3 Analysis 4 Analysis 5 Analysis 6 Analysis 7
GSK Medice: Pazopanib Study Number: 114430 (WEUKSTV4601) Title: Postmarketg Hepatic Monitorg for Pazopanib Observational Databases Study Rationale: As part of the EMA postapproval regulatory commitments,
More informationIntroduction. Keywords Hepatotoxicity Liver chemistry Renal cell carcinoma Pazopanib Anti-VEGF
Cancer Chemother Pharmacol (2016) 78:559 566 DOI 10.1007/s00280-016-3112-9 ORIGINAL ARTICLE Occurrence of hepatotoxicity with pazopanib and other anti VEGF treatments for renal cell carcinoma: an observational
More informationManagement of Patients with Past or Present Hepatic Abnormalities
S21 Management of Patients with Past or Present Hepatic Abnormalities Evidence Based Medicine Official recommendations Expert opinion Course of action before tocilizumab therapy in patients with a history
More informationOutcomes: Initially, our primary definitions of pneumonia was severe pneumonia, where the subject was hospitalized
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
More informationAn oncology reviewer s perspective on hepatotoxicity
An oncology reviewer s perspective on hepatotoxicity Gideon Blumenthal, MD March 21 2013 FDA/Critical Path DILI conference Disclaimer: Views expressed herein are my own and may not necessarily reflect
More informationNew Evidence reports on presentations given at EULAR Safety and Efficacy of Tocilizumab as Monotherapy and in Combination with Methotrexate
New Evidence reports on presentations given at EULAR 2009 Safety and Efficacy of Tocilizumab as Monotherapy and in Combination with Methotrexate Report on EULAR 2009 presentations Tocilizumab inhibits
More informationHBV Forum 2 April 18 th 2017 Hilton Amsterdam.
HBV Forum 2 April 18 th 2017 Hilton Amsterdam www.forumresearch.org Detection, Assessment and Management of DILI During Drug Development for HBV: The IQ DILI Initiative. Arie Regev, MD Global Patient Safety
More informationDocetaxel + Nintedanib
Docetaxel + Nintedanib Available for Routine Use in Burton in-patient Derby in-patient Burton day-case Derby day-case Burton community Derby community Burton out-patient Derby out-patient Indication Second
More informationA Case Study of Graphics in Clinical Trials: The Role of Statistical Graphics in the Recent Submission/Approval of GSK's Votrient in the US
A Case Study of Graphics in Clinical Trials: The Role of Statistical Graphics in the Recent Submission/Approval of GSK's Votrient in the US Michael Durante Biostatistics Development Partners, GlaxoSmithKline
More informationDeclaration of Conflict of Interest. No potential conflict of interest to disclose with regard to the topics of this presentations.
Declaration of Conflict of Interest No potential conflict of interest to disclose with regard to the topics of this presentations. Clinical implications of smoking relapse after acute ischemic stroke Furio
More informationDocetaxel. Class: Antineoplastic agent, Antimicrotubular, Taxane derivative.
Docetaxel Class: Antineoplastic agent, Antimicrotubular, Taxane derivative. Indications: -Breast cancer: -Non small cell lung cancer -Prostate cancer -Gastric adenocarcinoma _Head and neck cancer Unlabeled
More informationBosentan Accord Prescriber s Guide. This guide provides important safety information about Bosentan Accord regarding the risk
Bosentan Accord Prescriber s Guide This guide provides important safety information about Bosentan Accord regarding the risk of liver injury and birth defects. Information is provided concerning the monitoring
More informationYes, the proposed stopping rules are too conservative. John R. Senior, M.D. 25 March 2010 Rethink Stopping Rules 1
Yes, the proposed stopping rules are too conservative John R. Senior, M.D. 25 March 2010 Rethink Stopping Rules 1 Guidelines for study stop rules: ALT/AST > 8X ULN ALT/AST remains > 5X ULN over 2 wks ALT/AST
More informationQuantifying the hepatotoxic risk of alcohol consumption in patients with rheumatoid arthritis taking methotrexate
Quantifying the hepatotoxic risk of alcohol consumption in patients with rheumatoid arthritis taking methotrexate BMJ Jenny H Humphreys, Alexander Warner, Ruth Costello, Mark Lunt, Suzanne M M Verstappen,
More informationLapatinib and Capecitabine Therapy
Lapatinib and Capecitabine Therapy This protocol should be read in conjunction with NCCP protocol 00216 Capecitabine Monotherapy. INDICATIONS FOR USE: INDICATION Treatment of adult patients with breast
More informationALECENSA (alectinib) oral capsule
ALECENSA (alectinib) oral capsule Coverage for services, procedures, medical devices and drugs are dependent upon benefit eligibility as outlined in the member's specific benefit plan. This Pharmacy Coverage
More informationStudy No Title : Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment:
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
More informationSponsor / Company: Sanofi Drug substance(s): Docetaxel (Taxotere )
These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert in the country of prescription. Sponsor / Company: Sanofi Drug substance(s):
More informationTykerb. Tykerb (lapatinib) Description
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 Subject: Tykerb Page: 1 of 5 Last Review Date: June 24, 2016 Tykerb Description Tykerb (lapatinib) Background
More informationTykerb. Tykerb (lapatinib) Description
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.21.23 Subject: Tykerb Page: 1 of 5 Last Review Date: December 8, 2017 Tykerb Description Tykerb (lapatinib)
More informationSupplementary Online Content
Supplementary Online Content Powles T, O Donnell PH, Massard C, et al. Efficacy and safety of durvalumab in locally advanced or metastatic urothelial carcinoma: updated results from a phase 1/2 openlabel
More informationSAFETY CONSIDERATIONS WITH YONDELIS (trabectedin)
SAFETY CONSIDERATIONS WITH YONDELIS (trabectedin) Please see Important Safety Information on pages 14 and 15 and accompanying full Prescribing Information. YONDELIS (trabectedin) STUDY DESIGN INDICATION
More information1.0 Abstract. Title. Keywords
1.0 Abstract Title Real World Evidence of the Effectiveness of Paritaprevir/r Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients with Chronic Hepatitis C - An Observational Study in Austria (REAL) Keywords
More informationPazopanib (Continuous vs Drug-free Interval Strategy) STAR Trial
Pazopanib (Continuous vs Drug-free Interval Strategy) STAR Trial A Randomised Multi-Stage Phase II/III Trial of Standard first-line therapy (sunitinib or pazopanib) Comparing Temporary Cessation with Allowing
More informationNCCP Chemotherapy Regimen. PAZOPanib Therapy
INDICATIONS FOR USE: PAZOPanib Therapy Regimen Code INDICATION ICD10 First line treatment of advanced Renal Cell Carcinoma (RCC) in adults and for C64 00445a patients who have received prior cytokine therapy
More informationKynamro. Kynamro (mipomersen) Description
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.40.02 Subject: Kynamro Page: 1 of 5 Last Review Date: September 15, 2017 Kynamro Description Kynamro
More informationDrafting a Coverage Authorization Request Letter
Drafting a Coverage Authorization Request Letter The following information is presented for informational purposes only and is not intended to provide reimbursement or legal advice. Laws, regulations,
More informationLearning Objectives. Disclosures. Self Assessment Questions. Background
Association of Hyperuricemia with Liver Dysfunction amongst Adults with Metabolic Disorders in the United States: A Cross Sectional Study Disclosures Dr. Prashant Sakharkar and Dr. Subrata Deb declare(s)
More informationKynamro. Kynamro (mipomersen) Description
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.40.02 Subject: Kynamro Page: 1 of 5 Last Review Date: December 2, 2016 Kynamro Description Kynamro (mipomersen)
More information(For National Authority Use Only) Name of Study Drug: to Part of Dossier:
2.0 Synopsis Abbott Laboratories Individual Study Table Referring to Part of Dossier: (For National Authority Use Only) Name of Study Drug: Volume: ABT-335 Name of Active Ingredient: Page: ABT-335, A-7770335.115
More informationHCV e HBV nelle malattie oncologiche
INFEZIONI DA HBV E HCV PROBLEMATICHE ATTUALI Cagliari, 7 Dicembre 2018 HCV e HBV nelle malattie oncologiche Marta Muntoni, MD UOC Oncologia Medica AOBrotzu, P.O. Businco - Cagliari - INTRODUCTION Ø Chemotherapy-induced
More informationStudy Exposures, Outcomes:
GSK Medicine: Coreg IR, Coreg CR, and InnoPran Study No.: WWE111944/WEUSRTP3149 Title: A nested case-control study of the association between Coreg IR and Coreg CR and hypersensitivity reactions: anaphylactic
More informationDOSING GUIDE. Indications. Important Safety Information. Enable the immune system. RECOGNIZE. RESPOND.
DOSING GUIDE For patients with unresectable Stage III NSCLC following concurrent CRT For patients with locally advanced or metastatic UC previously treated with platinum-based therapy Enable the immune
More informationNCCP Chemotherapy Regimen. Alectinib Monotherapy
INDICATIONS FOR USE: Alectinib INDICATION ICD10 Regimen Code *Reimbursement Indicator Treatment of adult patients with anaplastic lymphoma kinase (ALK)- positive advanced non-small cell lung cancer (NSCLC)
More information2014 Oncology Measures Group Overview
2014 Oncology Measures Group Overview The Oncology Measures Group is a reporting option that significantly reduces the burden of participation in the Physician Quality Reporting System (PQRS). Source:
More informationGemcitabine + Capecitabine (ESPAC-4 Trial)
Gemcitabine + Capecitabine (ESPAC-4 Trial) European Study Group For Pancreatic Cancer - Trial 4. Combination versus single agent chemotherapy in resectable pancreatic ductal and ampullary cancers. ***
More informationThe legally binding text is the original French version
The legally binding text is the original French version TRANSPARENCY COMMITTEE OPINION 29 November 2006 TAXOTERE 20 mg, concentrate and solvent for infusion in single-dose vials of 7 ml, individually packed
More informationNCCP Chemotherapy Protocol
Docetaxel Monotherapy 50mg/m 2 INDICATIONS FOR USE: INDICATION In combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer
More informationIpilimumab Monotherapy
INDICATIONS FOR USE: Ipilimumab INDICATION ICD10 Regimen Code *Reimbursement Indicator Treatment of advanced (unresectable or metastatic) melanoma in adults C43 00105a ODMS *If a reimbursement indicator
More informationNew Targeted Agents Demonstrate Greater Efficacy and Tolerability in the Treatment of HER2-positive Breast Cancer
New Evidence reports on presentations given at ASCO 2012 New Targeted Agents Demonstrate Greater Efficacy and Tolerability in the Treatment of HER2-positive Breast Cancer Presentations at ASCO 2012 Breast
More informationBreast Pathway Group Docetaxel in Advanced Breast Cancer
Breast Pathway Group Docetaxel in Advanced Breast Cancer Indication: First-line palliative treatment, with or without trastuzumab, for advanced breast cancer in patients for whom an anthracycline is not
More informationYONDELIS (trabectedin) DOSING & ADMINISTRATION GUIDE
YONDELIS (trabectedin) DOSING & ADMINISTRATION GUIDE INDICATION YONDELIS (trabectedin) is indicated for the treatment of patients with unresectable or metastatic liposarcoma or leiomyosarcoma who received
More informationClinical Policy: Lapatinib (Tykerb) Reference Number: CP.PHAR.79 Effective Date: Last Review Date: 11.17
Clinical Policy: (Tykerb) Reference Number: CP.PHAR.79 Effective Date: 10.01.11 Last Review Date: 11.17 Line of Business: Medicaid Revision Log See Important Reminder at the end of this policy for important
More informationSujita Narayan. Research in Pharmacoepidemiology National School of Pharmacy, University of Otago
Sujita Narayan Research in Pharmacoepidemiology (RIPE) @ National School of Pharmacy, University of Otago Medication Possession Ratio (MPR) What is MPR? Measure of adherence Ratio of the no. of doses dispensed
More informationMEET MARY KISQALI PATIENT PROFILES
KISQALI PATIENT PROFILES MEET MARY Mary was recently diagnosed with HR+/HER2- metastatic breast cancer Review the data from the MONALEESA-2 trial to see how patients like Mary responded The patient profile
More informationACTEMRA Risk Mitigation Strategy Presenter Name, Degree
ACTEMRA Risk Mitigation Strategy Presenter Name, Degree Medical Science Liaison Genentech, Inc. 1 Indications and Dosage Rheumatoid Arthritis (RA) (1 of 2) Indication in RA ACTEMRA (tocilizumab) is indicated
More informationPart I. Prior Authorization Criteria and Policy
Texas Vendor Drug Program Antiviral Agents for Hepatitis C Virus Initial Authorization Request (Medicaid) Part I. Prior Authorization Criteria and Policy March 2018-E I. Eligibility 1. Patient is enrolled
More informationPercentage of patients who underwent endoscopic procedures following SWL
Non-QPP Measures Measure ID Measure Title Definition Type Domain 1 AQUA12 Benign Prostate Hyperplasia: IPSS improvement after diagnosis Percentage of patients with NEW diagnosis of clinically significant
More informationIpilimumab in Melanoma
Ipilimumab in Melanoma Indication: Advanced (unresectable or metastatic) melanoma in adults who have received prior therapy LCNDG criteria to be met: Histologically confirmed unresectable stage III or
More informationadherence research Introduction Breast cancer is the most common cancer diagnosis among women in the United States,
Psychosocial factors in adjuvant hormone therapy for breast cancer: An emerging context for adherence research Introduction Breast cancer is the most common cancer diagnosis among women in the United States,
More informationFinal Clinical Study Report. to the Dossier SYNOPSIS. Final Clinical Study Report for Study AI463110
BMS-475 AI463 Name of Sponsor/Company: Bristol-Myers Squibb Individual Study Table Referring to the Dossier For National Authority Use Only) Name of Finished Product: Baraclude Name of Active Ingredient:
More informationNCCP Chemotherapy Regimen. Dose Dense DOXOrubicin, Cyclophosphamide (AC 60/600) 14 day followed by PACLItaxel (175) 14 day Therapy (DD AC-T)
Dose Dense DOXOrubicin, Cyclophosphamide (AC 60/600) 14 day followed by PACLItaxel (175) 14 day Therapy (DD AC-T) Note: There is an option for DOXOrubicin, cyclophosphamide followed by weekly PACLItaxel
More informationSeladelpar Interim Data Phase 2 Low Dose Study in PBC. July 17, 2017
Seladelpar Interim Data Phase 2 Low Dose Study in PBC July 17, 2017 Seladelpar Phase 2 Low Dose Study in PBC Potential for superior efficacy and better tolerability 39% (5 mg) and 45% (10 mg) reductions
More informationProspective, Open Label, Phase 3 Study of Levoketoconazole in Cushing Syndrome (SONICS): Primary Safety and Efficacy Results
Prospective, Open Label, Phase 3 Study of Levoketoconazole in Cushing Syndrome (SONICS): Primary Safety and Efficacy Results Eliza B. Geer Maria Fleseriu, 1 Rosario Pivonello, 2 Atanaska Elenkova, 3 Roberto
More informationNCCP Chemotherapy Regimen
INDICATIONS FOR USE: Pembrolizumab 2mg/kg INDICATION ICD10 Regimen Code *Reimbursement Status First line monotherapy for the treatment of advanced (unresectable or C43 00347a ODMS metastatic) melanoma
More informationJuxtapid. Juxtapid (lomitapide) Description
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 Subject: Juxtapid Page: 1 of 6 Last Review Date: September 20, 2018 Juxtapid Description Juxtapid (lomitapide)
More informationWest of Scotland Cancer Network Chemotherapy Protocol
West of Scotland Cancer Network Chemotherapy Protocol DOCETAXEL/TRASTUZUMAB (BRWOS-005/1) Indication Docetaxel in combination with is indicated for the treatment of patients with HER2 overexpressing locally
More information5-Fluorouracil, epirubicin 100 and Cyclophosphamide (FEC 100) Therapy
5-Fluorouracil, epirubicin 100 and Cyclophosphamide (FEC 100) Therapy INDICATIONS FOR USE: Regimen INDICATION ICD10 Code Neoadjuvant treatment for breast carcinoma C50 00265a Adjuvant treatment for breast
More informationSupplementary Table 1. The distribution of IFNL rs and rs and Hardy-Weinberg equilibrium Genotype Observed Expected X 2 P-value* CHC
Supplementary Table 1. The distribution of IFNL rs12979860 and rs8099917 and Hardy-Weinberg equilibrium Genotype Observed Expected X 2 P-value* CHC rs12979860 (n=3129) CC 1127 1145.8 CT 1533 1495.3 TT
More informationWARNING, CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS,
Celgene Corporation 86 Morris Avenue Summit, New Jersey 07901 Tel 908-673-9000 Fax 908-673-9001 October 2012 NEW Indication Announcement for ABRAXANE for Injectable Suspension (paclitaxel protein-bound
More informationIpilimumab (skin) Indication Advanced (unresectable or metastatic) melanoma in patients who have received prior therapy.
Ipilimumab (skin) Indication Advanced (unresectable or metastatic) melanoma in patients who have received prior therapy. (NICE TA268) ICD-10 codes Codes prefixed with C43 Regimen details Day Drug Dose
More informationDurvalumab (previously known as MEDI 4736) Maintenance (Arm A3) PLATFORM study
Durvalumab (previously known as MEDI 4736) Maintenance (Arm A3) PLATFORM study PLAnning Treatment For Oesophago-gastric cancer: a Randomised Maintenance therapy trial. ***See Protocol for further details***
More informationAbiraterone and Prednisolone Therapy
INDICATIONS FOR USE: Abiraterone and Prednisolone Therapy Regimen Code INDICATION ICD10 Abiraterone is indicated in combination with prednisone or prednisolone for the treatment of metastatic castration
More informationAtezolizumab Non-small cell lung cancer
Systemic Anti Cancer Treatment Protocol Atezolizumab Non-small cell lung cancer PROTOCOL REF: MPHAATNSCLC (Version No: 1.0) Approved for use in: Locally advanced/metastatic non squamous or squamous non-small
More informationManagement of patients with should not use past or present history of solid cancer
Practical management of patients receiving abatacept 1 Management of patients with should not use past or present history of solid Evidence-based Medicine Official Recommendations Expert opinion Steps
More informationA Rational Evidence-based Approach to Abnormal Liver Tests
A Rational Evidence-based Approach to Abnormal Liver Tests Jane D. Ricaforte-Campos, MD FPCP, FPSG, FPSDE 2013 HSP Post-graduate Course Radisson Blu Hotel, Cebu City misnomer Liver Function Tests Does
More informationSynopsis (C0168T60) Associated with Module 5.3 of the Dossier
Protocol: C0168T60 EudraCT No.: 2004-000524-32 Title of the study: A Phase II, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Anti-TNFα Monoclonal
More informationPositive Rechallenge: What Clinical Trial Data Tell Us Julie Papay, Pharm.D. UCB BioSciences Global Patient Safety
Positive Rechallenge: What Clinical Trial Data Tell Us Julie Papay, Pharm.D. UCB BioSciences Global Patient Safety Drug-Induced Liver Injury (DILI) Conference XVI Wednesday 23 March 2016 The comments provided
More informationGSK Medicine: Study No.: Title: Rationale: Study Period Objectives: Indication: Study Investigators/Centers: Research Methods: Data Source:
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
More informationBosulif. Bosulif (bosutinib) Description
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.21.22 Section: Prescription Drugs Effective Date: April 1,2018 Subject: Bosulif Page: 1 of 5 Last Review
More informationBreast Pathway Group Oral Vinorelbine 3 weekly cycle in Advanced Breast Cancer
Breast Pathway Group Oral Vinorelbine 3 weekly cycle in Advanced Breast Cancer Indication: Regimen details: Administration: Frequency: Pre-medication: Anti- emetics: Supportive medication: Extravasation:
More informationMolina Healthcare of Texas Hepatitis C Drugs (Medicaid)
Texas Standard Prior Authorization Form Addendum Molina Healthcare of Texas Hepatitis C Drugs (Medicaid) This fax machine is located in a secure location as required by HIPAA Regulations. Complete / Review
More informationALUNBRIG (brigatinib) oral tablet
ALUNBRIG (brigatinib) oral tablet Coverage for services, procedures, medical devices and drugs are dependent upon benefit eligibility as outlined in the member's specific benefit plan. This Pharmacy Coverage
More informationOrkambi. Orkambi (lumacaftor/ivacaftor) Description
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.45.06 Subject: Orkambi Page: 1 of 6 Last Review Date: November 30, 2018 Orkambi Description Orkambi (lumacaftor/ivacaftor)
More informationMipomersen (ISIS ) Page 2 of 1979 Clinical Study Report ISIS CS3
(ISIS 301012) Page 2 of 1979 2 SYNOPSIS ISIS 301012-CS3 synopsis Page 1 Title of Study: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics,
More informationEVIDENCE IN BRIEF OVERALL CLINICAL BENEFIT
perc deliberated upon the cost-effectiveness of lapatinib plus letrozole and discussed the challenges of using letrozole alone as a comparator and/or using trastuzumab plus anastrozole as a comparator.
More informationLONSURF (trifluridine-tipiracil) oral tablet
LONSURF (trifluridine-tipiracil) oral tablet Coverage for services, procedures, medical devices and drugs are dependent upon benefit eligibility as outlined in the member's specific benefit plan. This
More informationA Step Forward in Cancer Patient Care:
Hong Kong Pharmacy Conference 2018 A Step Forward in Cancer Patient Care: The Experience of Oncology Pharmacist-Managed Trastuzumab Clinic in Queen Mary Hospital Amy Yuen Clinical Pharmacist 24 Oct 2017.
More information2015 Physician Quality Reporting System Data Collection Form: Oncology (for patients aged 18 and older)
2015 Physician Quality Reporting System Data Collection Form: Oncology (for patients aged 18 and older) IMPORTANT: Any measure with a 0% performance rate (100% for inverse measures) is not considered satisfactory
More informationDosage and Administration
SIRTURO product information for healthcare providers 2 WARNINGS: An increased risk of death was seen in the SIRTURO (bedaquiline) treatment group (9/79, 11.4%) compared to the placebo treatment group (2/81,
More informationKey Words. FDA summary Metastatic breast cancer Multidrug resistant Lapatinib Capecitabine
The Oncologist Regulatory Issues FDA Drug Approval Summary: Lapatinib in Combination with Capecitabine for Previously Treated Metastatic Breast Cancer That Overexpresses HER-2 QIN RYAN, AMNA IBRAHIM, MARTIN
More informationDiscontinuation of Nucleotide or Nucleoside Analogue therapy for Chronic Hepatitis B infection
Discontinuation of Nucleotide or Nucleoside Analogue therapy for Chronic Hepatitis B infection Dr Abid Suddle Institute of Liver Studies King s College Hospital Why consider discontinuation of NA therapy?
More information1. Based on A.S. s labs and presentation, what type of liver injury would you classify her as experiencing?
Drug Induced Liver Injury Cases Case #1 A.S., a16 year-old female, was found by her pediatrician to be slightly jaundiced during a routine school physical. She denied any history of liver disease, abdominal
More informationAmy Larrick Chavez-Valdez, Director, Medicare Drug Benefit and C & D Data Group
DEPARTMENT OF HEALTH & HUMAN SERVICES Centers for Medicare & Medicaid Services 7500 Security Boulevard Baltimore, Maryland 21244-1850 CENTER FOR MEDICARE TO: FROM: SUBJECT: All Part D Sponsors Amy Larrick
More informationClinialTrials.gov Identifier: sanofi-aventis. Sponsor/company: Date: 18 February 2008
These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert in the country of prescription Sponsor/company: sanofi-aventis ClinialTrials.gov
More informationRisk Management Plans Review of Experience
Risk Management Plans Review of Experience Dr Stella Blackburn Risk Management Plans November 05 till September 06 Positive CHMP Opinions RMP MAA 31 29 Extensions of Indication 27 13 Line Extensions 3
More informationSutent. Sutent (sunitinib) Description
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.21.95 Subject: Sutent Page: 1 of 6 Last Review Date: March 16, 2018 Sutent Description Sutent (sunitinib)
More informationSYNOPSIS. Clinical Study Report AI Addendum #1. Open-label Dosing Phase
Name of Sponsor/Company: Bristol-Myers Squibb Name of Finished Product: Individual Study Table Referring to the Dossier (For National Authority Use Only) Name of Active Ingredient: Entecavir SYNOPSIS Clinical
More information2014 Physician Quality Reporting System Data Collection Form: Oncology (for patients aged 18 and older)
2014 Physician Quality Reporting System Data Collection Form: Oncology (for patients aged 18 and older) Physician Name: Patient Name: Last First MI Date of Birth: / / mm dd yyyy Gender: M F Medical Record
More informationHepatitis C: Surveillance, Case Definition, and Investigation
Hepatitis C: Surveillance, Case Definition, and Investigation Tuesday, November 14, 2017 10am 11:30am NJ Department of Health Communicable Disease Service Welcome to the Webinar Today s webinar is being
More informationSponsor. Generic Drug Name. Trial Indication(s) Protocol Number. Protocol Title. Clinical Trial Phase. Study Start/End Dates. Novartis.
Sponsor Novartis Generic Drug Name Lumiracoxib Trial Indication(s) Not applicable Protocol Number CCOX189A2483 Protocol Title A retrospective pharmacogenetics analysis of patients with elevated liver enzymes
More informationSupplementary materials
Supplementary materials Table S Adverse events identified by participants diary logs and blood hematologic and biochemical tests (n=2) group (n=) Placebo group (n=) P value for chi-squared test Asthma
More informationSponsor / Company: Sanofi Drug substance(s): AMARYL M (1/250 mg) / HOE490
These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert in the country of prescription. Sponsor / Company: Sanofi Drug substance(s):
More informationColorado State Board of Medical Examiners Policy
POLICY NUMBER: 10-14 Title: Guidelines for the Use of Controlled Substances for the Treatment of Pain Date Issued: May 16, 1996 Date(s) Revised: November 18, 2004 Reference: 12-36-117, C.R.S. Purpose:
More informationNCCP Chemotherapy Regimen
DOXOrubicin, Cyclophosphamide (AC 60/600) 21 day followed by weekly PACLitaxel (80) Therapy (AC-T) Note: There is an option for Dose Dense DOXOrubicin, cyclophosphamide PACLitaxel (DD AC T) therapy described
More informationNCCP Chemotherapy Regimen. Dose Dense DOXOrubicin, Cyclophosphamide (AC 60/600) 14 day followed by PACLitaxel (80) 7 day Therapy (DD AC-T)
Dose Dense DOXOrubicin, Cyclophosphamide (AC 60/600) 14 day followed by PACLitaxel (80) 7 day Therapy (DD AC-T) INDICATIONS FOR USE: INDICATION Adjuvant Treatment of High Risk Node Negative or Node Positive
More informationHepatitis C January 26, 2018
Hepatitis C January 26, 2018 Case Investigation Guidelines Contents A. Purpose...2 B. Case Definitions...2 a. Acute Hepatitis C (2016...2 b. Chronic Hepatitis C (2016)...3 c. Perinatal Hepatitis C (2017
More informationDAYS IN PANCREATIC CANCER
HOSPITAL AND MEDICAL CARE DAYS IN PANCREATIC CANCER Annals of Surgical Oncology, March 27, 2012 Casey B. Duncan, Kristin M. Sheffield, Daniel W. Branch, Yimei Han, Yong-Fang g Kuo, James S. Goodwin, Taylor
More information43rd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) A Cutrell, J Hernandez, M Edwards, J Fleming, W Powell, T Scott
43rd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) Poster H-2013 Clinical Risk Factors for Hypersensitivity Reactions to Abacavir: Retrospective Analysis of Over 8,000 Subjects
More information