MEET MARY KISQALI PATIENT PROFILES
|
|
- Eustace Lyons
- 5 years ago
- Views:
Transcription
1 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 herein is hypothetical and based on characteristics of real patients from the MONALEESA-2 trial. MONALEESA-2 study description KISQALI (ribociclib) was studied in MONALEESA-2, a robust, randomized, double-blind, placebo-controlled, multicenter, phase III trial in postmenopausal women with HR+/HER2- ABC who received no prior therapy for advanced disease. Patients were stratified by presence of liver and/or lung metastases and randomized 1:1 to receive either KISQALI 600 mg (3 weeks on, 1 week off) and letrozole 2.5 mg (continuously) or placebo (3 weeks on, 1 week off) and letrozole (continuously). The primary end point was PFS using RECIST v1.1; secondary end points included OS, ORR, QOL, and safety; TTR was an exploratory end point.1-3 Indication KISQALI (ribociclib) is indicated in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. Important Safety Information QT interval prolongation. KISQALI has been shown to prolong the QT interval in a concentration-dependent manner, with estimated mean increase in QTc interval exceeding 20 ms (22.9 ms [90% CI: ]) at the mean steady-state Cmax following administration at the 600-mg once-daily dose. In MONALEESA-2, one patient (0.3%) had >500 msec postbaseline QTcF value (average of triplicate), and 9 of 329 patients (3.0%) had a >60 msec increase from baseline in QTcF intervals (average of triplicate). These electrocardiogram (ECG) changes occurred within the first 4 weeks of treatment and were reversible with dose interruption. There were no reported cases of torsades de pointes. Syncope occurred in 9 patients (2.7%) in the KISQALI + letrozole arm vs 3 patients (0.9%) in the placebo + letrozole arm. In the KISQALI + letrozole treatment arm, there was 1 (0.3%) sudden death in a patient with grade 3 hypokalemia and grade 2 QT prolongation. ABC=advanced breast cancer; HER2-=human epidermal growth factor receptor 2-negative; HR+=hormone receptor-positive; ORR=overall response rate; OS=overall survival; PFS=progression-free survival; QOL=quality of life; RECIST=Response Evaluation Criteria In Solid Tumors; TTR=time to response. 1
2 Mary De novo disease Mary has had many experiences throughout her life. At 62 years old, she s a mother of 2, grandmother of 2, and financial advisor at a community bank, where she s worked for more than 30 years. Her youngest son is due to be married in less than 3 months, and she is excited to celebrate with her family. Now, Mary faces a new experience, as she s been newly diagnosed with metastatic breast cancer. History No prior history of breast cancer Initial presentation Mammogram revealed suspicious mass in right breast Persistent pain in upper back and frequent fatigue ECOG PS 0 Workup Biopsy confirmed HR+/HER2- breast cancer with distant metastases in the cervical lymph nodes Metastases in T5 vertebra confirmed via bone scan CT scan revealed no evidence of visceral metastases Diagnosis De novo HR+/HER2- metastatic breast cancer with bone metastases Important Safety Information (continued) QT interval prolongation (continued). Assess ECG prior to initiation of treatment. Initiate treatment with KISQALI only in patients with QTcF values <450 msec. Repeat ECG at approximately Day 14 of the first cycle, at the beginning of the second cycle, and as clinically indicated. Monitor serum electrolytes (including potassium, calcium, phosphorus, and magnesium) prior to the initiation of treatment, at the beginning of each of the first 6 cycles, and as clinically indicated. Correct any abnormality before starting therapy with KISQALI. CT=computed tomography; ECOG PS=Eastern Cooperative Oncology Group performance status; T5=5th thoracic vertebra. 2
3 Patients with characteristics similar to Mary s were enrolled in MONALEESA-2 1,2 SELECT BASELINE CHARACTERISTICS 1,2 In each arm ~34 % Newly diagnosed disease ~74 % Bone metastases ~61 % ECOG PS 0 N=668 Characteristic KISQALI + letrozole (n=334) Placebo + letrozole (n=334) Age Median (range) 62 (23 91) 63 (29 88) Metastatic sites <3 220 (65.9%) 221 (66.2%) (34.1%) 113 (33.8%) Visceral disease a No 137 (41.0%) 138 (41.3%) Yes 197 (59.0%) 196 (58.7%) Grade 1/2 elevated ALT b No c 289 (86.5%) 282 (85.5%) Yes 45 (13.5%) 48 (14.5%) Grade 1/2 elevated AST b No d 282 (84.4%) 282 (85.5%) Yes 52 (15.6%) 48 (14.5%) ALT=alanine aminotransferase; AST=aspartate aminotransferase. a Visceral involvement included liver, lung, and other visceral metastases. 1 b Placebo arm n= c Includes patients with missing elevations; n=2 (0.6%) in the KISQALI + letrozole arm and n=0 (0.0%) in the placebo + letrozole arm. 2 d Includes patients with missing elevations; n=3 (0.9%) in the KISQALI + letrozole arm and n=1 (0.3%) in the placebo + letrozole arm. 2 Have you considered KISQALI + the AI of your choice to deliver first-line efficacy for patients like Mary? 1,3 AI=aromatase inhibitor. 3
4 RAPID and SUSTAINED efficacy... 44% reduction in risk of progression or death with KISQALI (ribociclib) + letrozole vs placebo + letrozole (HR=0.556 [95% CI: ]; P<0.0001) (primary end point, interim analysis). 3 PFS PER INVESTIGATOR ASSESSMENT (SUBSEQUENT PREPLANNED OS ANALYSIS) 4 PROBABILITY OF PFS (%) HR=0.568 (95% CI: ) KISQALI + letrozole mpfs: 25.3 months (95% CI: ) n=334 Placebo + letrozole mpfs: 16.0 months (95% CI: ) n=334 mpfs beyond 25 months Number of patients still at risk TIME (MONTHS) KISQALI + letrozole Placebo + letrozole mpfs=median progression-free survival. Rapid separation of the PFS curves evident at 8 weeks 4 Results reported at 8 weeks were not prespecified and are observational in nature; as such, there was no prespecified statistical procedure controlling for type 1 error QOL preserved throughout treatment 5 EORTC QLQ-C30 was one of the questionnaires used to assess HRQOL* During treatment, overall HRQOL was maintained from baseline and was similar in both arms. There was no significant difference in the time to deterioration of global health status/qol by 10% (HR=0.944 [95% CI: ]) At disease progression or EOT, overall HRQOL worsened in both arms Clinically meaningful reduction in pain for more than 1 year 5 Reduction in pain was one component of the composite* Compliance rate was >90% through 76 weeks (Cycle 19), and the sample size decreased over time as patients progressed or stopped treatment 60 weeks of clinically meaningful improvement in pain (>5 points) observed starting at 8 weeks with KISQALI + letrozole vs non-meaningful improvement in pain ( 5 points) in the placebo + letrozole arm over the same time period, except for Cycles 7 and 15 Beyond 60 weeks, the pain reduction compared to baseline was not clinically meaningful in either arm. Pain scores increased slightly above baseline at time of disease progression/ end of treatment in both treatment arms KISQALI is not approved for pain reduction 3 EORTC QLQ-C30=European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30; EOT=end of treatment; HRQOL=health-related quality of life. * EORTC QLQ-C30 is a standard QOL, patient-reported outcome tool that includes 5 functional scales: physical, role, emotional, cognitive, and social; 3 symptom scales: fatigue, nausea and vomiting, and pain; 6 single items: dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties. 4 4
5 ... for patients like Mary3,4 FOREST PLOT ANALYSIS ACROSS SELECT SUBGROUPS1,2 Subgroup No. of Patients Hazard Ratio (95% CI) All patients ( ) Age <65 y 65 y ( ) 0.61 ( ) ( ) 0.46 ( ) ( ) 0.69 ( ) ( ) 0.45 ( ) Number of metastatic sites <3 3 Bone-only disease No Yes Newly diagnosed disease No Yes KISQALI + LETROZOLE BETTER PLACEBO + LETROZOLE BETTER The size of the data points is proportional to the number of patients included in the subgroup analysis. From N Engl J Med, Hortobagyi GN et al, Ribociclib as first-line therapy for HR-positive, advanced breast cancer, 375: Copyright 2016 Massachusetts Medical Society. Reprinted with permission from Massachusetts Medical Society. For patients like Mary, start with KISQALI + the AI of your choice for sustained first-line results3,4 Important Safety Information (continued) QT interval prolongation (continued). Avoid the use of KISQALI in patients who already have or who are at significant risk of developing QTc prolongation, including patients with: long QT syndrome uncontrolled or significant cardiac disease including recent myocardial infarction, congestive heart failure, unstable angina, and bradyarrhythmias electrolyte abnormalities Avoid using KISQALI with drugs known to prolong the QTc interval and/or strong CYP3A inhibitors, as this may lead to prolongation of the QTcF interval. Based on the observed QT prolongation during treatment, KISQALI may require dose interruption, reduction, or discontinuation. 5
6 Important Safety Information (continued) Hepatobiliary toxicity. In MONALEESA-2, increases in transaminases were observed. Grade 3 or 4 increases in alanine aminotransferase (ALT) (10% vs 1%) and aspartate aminotransferase (AST) (7% vs 2%) were reported in the KISQALI and placebo arms, respectively. Among the patients who had grade 3 ALT/AST elevation, the median time to onset was 57 days for the KISQALI + letrozole treatment group. The median time to resolution to grade 2 was 24 days in the KISQALI + letrozole treatment group. Concurrent elevations in ALT or AST >3 times the upper limit of normal (ULN) and total bilirubin >2 times the ULN, with normal alkaline phosphatase, in the absence of cholestasis occurred in 4 patients (1%) in MONALEESA-2, and all patients recovered after discontinuation of KISQALI. Perform liver function tests (LFTs) before initiating therapy with KISQALI. Monitor LFTs every 2 weeks for the first 2 cycles, at the beginning of each of the subsequent 4 cycles, and as clinically indicated. Based on the severity of the transaminase elevations, KISQALI may require dose interruption, reduction, or discontinuation. Recommendations for patients who have elevated AST/ALT grade 3 at baseline have not been established. Neutropenia. In MONALEESA-2, neutropenia was the most frequently reported adverse reaction (AR) (75%), and a grade 3/4 decrease in neutrophil count (based on laboratory findings) was reported in 60% of patients receiving KISQALI + letrozole. Among the patients who had grade 2, 3, or 4 neutropenia, the median time to grade 2 was 16 days. The median time to resolution of grade 3 (to normalization or grade <3) was 15 days in the KISQALI + letrozole treatment group. Febrile neutropenia was reported in 1.5% of patients receiving KISQALI and letrozole. Treatment discontinuation due to neutropenia was 0.9%. Perform complete blood count (CBC) before initiating therapy with KISQALI. Monitor CBC every 2 weeks for the first 2 cycles, at the beginning of each of the subsequent 4 cycles, and as clinically indicated. Based on the severity of the neutropenia, KISQALI may require dose interruption, reduction, or discontinuation. Embryofetal toxicity. Based on findings from animal studies and the mechanism of action, KISQALI can cause fetal harm when administered to a pregnant woman. In animal reproduction studies, administration of KISQALI to pregnant rats and rabbits during organogenesis caused embryofetal toxicities at maternal exposures that were 0.6 and 1.5 times the human clinical exposure, respectively, based on area under the curve. Advise pregnant women of the potential risk to a fetus. Advise women of reproductive potential to use effective contraception during therapy with KISQALI and for at least 3 weeks after the last dose. Adverse reactions. The most common ARs reported in the KISQALI + letrozole arm vs letrozole arm (incidence 20%) were neutropenia (75% vs 5%), nausea (52% vs 29%), fatigue (37% vs 30%), diarrhea (35% vs 22%), leukopenia (33% vs 1%), alopecia (33% vs 16%), vomiting (29% vs 16%), constipation (25% vs 19%), headache (22% vs 19%), and back pain (20% vs 18%). The most common grade 3/4 ARs (reported at a frequency >2%) were neutropenia (60% vs 1%), leukopenia (21% vs <1%), abnormal LFTs (10% vs 2%), lymphopenia (7% vs 1%), and vomiting (4% vs 1%), respectively. Laboratory abnormalities. The most common laboratory abnormalities occurring in patients receiving KISQALI + letrozole vs letrozole arm (all grades, incidence 20%) were leukocyte count decrease (93% vs 29%), neutrophil count decrease (93% vs 24%), hemoglobin decrease (57% vs 26%), lymphocyte count decrease (51% vs 22%), ALT increase (46% vs 36%), AST increase (44% vs 32%), platelet count decrease (29% vs 6%), and creatinine increase (20% vs 6%). The most common grade 3/4 laboratory abnormalities (incidence >2%) were neutrophil count decrease (60% vs <2%), leukocyte count decrease (34% vs <2%), lymphocyte count decrease (14% vs 4%), ALT increase (10% vs 1%), AST increase (7% vs 2%), and phosphorus decrease (6% vs 1%), respectively. References: 1. Hortobagyi GN, Stemmer SM, Burris HA, et al. Ribociclib as first-line therapy for HR-positive, advanced breast cancer. N Engl J Med. 2016;375(18): ;(suppl). 2. Data on file. Study CLEE011A2301. Novartis Pharmaceuticals Corp; Kisqali [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; Hortobagyi GN, Stemmer SM, Burris HA, et al. Updated results from MONALEESA-2, a phase III trial of first-line ribociclib plus letrozole versus placebo plus letrozole in hormone receptor-positive, HER2-negative advanced breast cancer. Ann Oncol doi: /annonc/mdy155 [Epub ahead of print]. 5. Verma S, O Shaughnessy J, Burris HA, et al. Health-related quality of life of postmenopausal women with hormone receptorpositive human epidermal growth factor receptor 2-negative advanced breast cancer treated with ribociclib + letrozole: results from MONALEESA-2. Breast Cancer Res Treat doi: /s z [Epub ahead of print]. Novartis Pharmaceuticals Corporation East Hanover, New Jersey Novartis 6/18 KIS
First-Line Ribociclib + Letrozole for Postmenopausal Women With HR+, HER2-, Advanced Breast Cancer: First Results From the Phase III MONALEESA-2 Study
First-Line Ribociclib + Letrozole for Postmenopausal Women With HR+, HER2-, Advanced Breast Cancer: First Results From the Phase III MONALEESA-2 Study Abstract LBA1 Hortobagyi GN, Stemmer SM, Burris HA,
More informationRIBOCICLIB EN PRIMERA LINEA DE TRATAMIENTO. Dra. Elena Aguirre H.U. Miguel Servet
RIBOCICLIB EN PRIMERA LINEA DE TRATAMIENTO Dra. Elena Aguirre H.U. Miguel Servet INTRODUCTION ADVANCED BREAST CANCER HR+/HER2- YES Consider Chemo VISCERAL CRISIS? NO Endocrine Therapy X3 Toxicity Progresive
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 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 informationDOSING AND ADMINISTRATION GUIDE
DOSING AND ADMINISTRATION GUIDE Indication TAVALISSE is a kinase inhibitor indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient
More informationPhase 3 Top-Line Results Show IBRANCE in Combination with Fulvestrant Meets Progression-Free Survival (PFS) Primary Endpoint
For immediate release: April 15, 2015 Media Contact: Sally Beatty (212) 733-6566 Investor Contact: Ryan Crowe (212) 733-8160 Pfizer Announces PALOMA-3 Trial for IBRANCE (Palbociclib) Stopped Early Due
More informationDRUG NAME: Ribociclib
DRUG NAME: Ribociclib SYNONYM(S): LEE011 1 COMMON TRADE NAME(S): KISQALI CLASSIFICATION: molecular targeted therapy Special pediatric considerations are noted when applicable, otherwise adult provisions
More informationPrimary Endpoint The primary endpoint is overall survival, measured as the time in weeks from randomization to date of death due to any cause.
CASE STUDY Randomized, Double-Blind, Phase III Trial of NES-822 plus AMO-1002 vs. AMO-1002 alone as first-line therapy in patients with advanced pancreatic cancer This is a multicenter, randomized Phase
More informationMetastatic breast cancer: sequence of therapies
Metastatic breast cancer: sequence of therapies Clinical Case Discussion Nadia Harbeck, MD PhD Breast Center, Department of Gynecology and Obstetrics University of Munich, Ludwig-Maximilians University
More informationANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked
More informationperc considered the clinically meaningful results in PFS, a manageable but not insignificant toxicity profile, no significant detriment in QoL, and a need for treatment options that improve survival and
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 informationKeywords CDK4/6 inhibitor Ribociclib Advanced breast cancer Health-related quality of life Endocrine therapy Hormone receptor-positive CLINICAL TRIAL
Breast Cancer Research and Treatment (18) 17:535 55 https://doi.org/1.17/s159-18-79-z CLINICAL TRIAL Health related quality of life of postmenopausal women with hormone receptor positive, human epidermal
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 informationVerzenio (abemaciclib) NEW PRODUCT SLIDESHOW
Verzenio (abemaciclib) NEW PRODUCT SLIDESHOW Introduction Brand name: Verzenio Generic name: Abemaciclib Pharmacological class: Kinase inhibitor Strength and Formulation: 50mg, 100mg, 150mg, 200mg; tabs
More informationMEET ROY*: A PATIENT WITH LIVER-LIMITED mcrc
MEET ROY*: A PATIENT WITH LIVER-LIMITED mcrc * A hypothetical case study of a patient eligible for first-line mcrc therapy. mcrc = metastatic colorectal cancer. WHAT CLINICAL CHARACTERISTICS AFFECT YOUR
More informationCase 1 Metastatic Pancreatic Adenocarcinoma: What Therapy Should I Select First?
Case 1 Metastatic Pancreatic Adenocarcinoma: What Therapy Should I Select First? Marc Peeters, MD, PhD Head of the Oncology Department Antwerp University Hospital Antwerp, Belgium marc.peeters@uza.be 71-year-old
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 informationCase #2: Hormonal Therapy for Advanced Premenopausal Breast Cancer
Case #2: Hormonal Therapy for Advanced Premenopausal Breast Cancer Fellow Presenter: Katherine Clifton, MD Faculty Discussant: Debu Tripathy, MD 7 th Annual June 1, 2018 Topics to Be Discussed: Staging
More informationGeneral Information, efficacy and safety data
Horizon Scanning in Oncology Horizon Scanning in Oncology 29 th Prioritization 4 th quarter 2016 General Information, efficacy and safety data Nicole Grössmann Sarah Wolf Claudia Wild Please note: Within
More informationDOSAGE FORMS AND STRENGTHS Tablets: 200 mg (3)
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use KISQALI safely and effectively. See full prescribing information for KISQALI. KISQALI (ribociclib)
More informationEdith A. Perez, Ahmad Awada, Joyce O Shaughnessy, Hope Rugo, Chris Twelves, Seock-Ah Im, Carol Zhao, Ute Hoch, Alison L. Hannah, Javier Cortes
BEACON: A Phase 3 Open-label, Randomized, Multicenter Study of Etirinotecan Pegol (EP) versus Treatment of Physician s Choice (TPC) in Patients With Locally Recurrent or Metastatic Breast Cancer Previously
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 informationDrug Niraparib Olaparib
Dear NCCN Value Pathway Committee, We are making this submission to provide information that we believe is relevant for developing NCCN Categories of Preference for the use of PARP inhibitors in recurrent
More informationFigure 1: PALLAS Study Schema. Endocrine adjuvant therapy may have started before randomization and be ongoing at that time.
Figure 1: PALLAS Study Schema Endocrine adjuvant therapy may have started before randomization and be ongoing at that time. Approximately 4600 patients from approximately 500 global sites will be randomized
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 informationExpert Review: The Role of PARP Inhibition in the Treatment of Breast Cancer. Reference Slides
Expert Review: The Role of PARP Inhibition in the Treatment of Breast Cancer Reference Slides Overview BRCA Mutations and Breast Cancer Patients with BRCA mutations have an estimated 55% to 65% cumulative
More informationasts DOSING GUIDE For advanced soft tissue sarcoma (asts) after prior chemotherapy
asts DOSING GUIDE For advanced soft tissue sarcoma (asts) after prior chemotherapy Indication VOTRIENT (pazopanib) tablets is indicated for the treatment of patients with advanced soft tissue sarcoma (STS)
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 informationBESPONSA (inotuzumab ozogamicin)
BESPONSA (inotuzumab ozogamicin) Fact Sheet BESPONSA (inotuzumab ozogamicin) is an antibody-drug conjugate (ADC) composed of a monoclonal antibody (mab) targeting CD22, a cell surface antigen expressed
More informationFIRST RESULTS OF NEW DATA OF ABRAXANE IN COMBINATION WITH ATEZOLIZUMAB PRESENTED AT ESMO 2018
FIRST RESULTS OF NEW DATA OF ABRAXANE IN COMBINATION WITH ATEZOLIZUMAB PRESENTED AT ESMO 2018 IMpassion130 reports first positive Phase III study results for a chemotherapy/immunotherapy (ABRAXANE plus
More informationThis clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data.
abcd Clinical Study for Public Disclosure This clinical study synopsis is provided in line with s Policy on Transparency and Publication of Clinical Study Data. The synopsis which is part of the clinical
More informationPlease consider the following information on ZYTIGA (abiraterone acetate). ZYTIGA - Compendia Communication - NCCN LATITUDE and STAMPEDE June 2017
Page 1 of 2 Janssen Scientific Affairs, LLC 1125 Trenton-Harbourton Road PO Box 200 Titusville, NJ 08560 800.526.7736 tel 609.730.3138 fax June 08, 2017 Joan McClure 275 Commerce Drive #300 Fort Washington,
More informationKarcinom dojke. PANEL: Semir Bešlija, Zdenka Gojković, Robert Šeparović, Tajana Silovski
Karcinom dojke PANEL: Semir Bešlija, Zdenka Gojković, Robert Šeparović, Tajana Silovski MBC: HER2 PHEREXA: Study Design Multicenter, randomized, open-label phase III trial Stratified by prior CNS disease,
More informationPFIZER INC. THERAPEUTIC AREA AND FDA APPROVED INDICATIONS: See USPI
PFIZER INC. These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert. For publications based on this study, see associated bibliography.
More informationChemotherapy and Immunotherapy in Combination Non-Small Cell Lung Cancer (NSCLC)
Chemotherapy and Immunotherapy in Combination Non-Small Cell Lung Cancer (NSCLC) Jeffrey Crawford, MD George Barth Geller Professor for Research in Cancer Co-Program Leader, Solid Tumor Therapeutics Program
More informationRecent advances in the management of metastatic breast cancer in older adults
Recent advances in the management of metastatic breast cancer in older adults Laura Biganzoli Medical Oncology Dept New Hospital of Prato Istituto Toscano Tumori Italy Important recent advances in the
More information(+1) Matti Ojanen (+44) Investor Contact: Jennifer M. Davis (+1)
For immediate release: October 24, 2012 Media Contact: Victoria Davis (+1) 347-558-3455 Matti Ojanen (+44) 7557-202-394 Investor Contact: Jennifer M. Davis (+1) 212-733-0717 Pfizer s XALKORI Receives Conditional
More informationTHE REAL DEAL ABOUT GETTING STARTED
THE REAL DEAL ABOUT GETTING STARTED Please see Important Safety Information throughout, and the Summary of Important Information on pages 44 47. Keeping it. INDICATIONS (ribociclib) is a prescription medicine
More informationThe next wave of successful drug therapy strategies in HER2-positive breast cancer. Hans Wildiers University Hospitals Leuven Belgium
The next wave of successful drug therapy strategies in HER2-positive breast cancer Hans Wildiers University Hospitals Leuven Belgium Trastuzumab in 1st Line significantly improved the prognosis of HER2-positive
More informationINITIATING ORAL AUBAGIO (teriflunomide) THERAPY
FOR YOUR PATIENTS WITH RELAPSING FORMS OF MS INITIATING ORAL AUBAGIO (teriflunomide) THERAPY INDICATION AUBAGIO (teriflunomide) is indicated for the treatment of patients with relapsing forms of multiple
More informationHOPA. Anaheim. Conference Highlights & Insights for Pharmacy Specialists
HOPA Hematology/Oncology Pharmacy Association 13th Annual Conference March 29 April 1, 2017 Anaheim, CA Anaheim Conference Highlights & Insights for Pharmacy Specialists FDA APPROVED FOR USE WITH ANY AI
More informationStudy Day 1 Study Days 2 to 9 Sequence 1 Placebo for moxifloxacin Study Days 2 to 8: placebo for pazopanib (placebopaz) 800 mg;
The study listed may include approved 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): SAR (iniparib)
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 informationManaging Acromegaly: Biochemical Control with SIGNIFOR LAR (pasireotide)
Managing Acromegaly: Biochemical Control with SIGNIFOR LAR (pasireotide) INDICATION AND USAGE SIGNIFOR LAR (pasireotide) for injectable suspension is a somatostatin analog indicated for the treatment of
More informationRubraca (rucaparib) Approved in the U.S. as Maintenance Treatment of Recurrent Ovarian Cancer
Rubraca (rucaparib) Approved in the U.S. as Maintenance Treatment of Recurrent Ovarian Cancer Rubraca is now indicated as maintenance treatment for women with recurrent ovarian cancer who are in a complete
More informationClinical Trial Results Database Page 1
Page 1 Sponsor Novartis UK Limited Generic Drug Name Letrozole/FEM345 Therapeutic Area of Trial Localized ER and/or PgR receptor positive breast cancer Study Number CFEM345EGB07 Protocol Title This study
More informationpan-canadian Oncology Drug Review Initial Clinical Guidance Report Ribociclib (Kisqali) for Metastatic Breast Cancer March 29, 2018
pan-canadian Oncology Drug Review Initial Clinical Guidance Report Ribociclib (Kisqali) for Metastatic Breast Cancer March 29, 2018 DISCLAIMER Not a Substitute for Professional Advice This report is primarily
More informationBR is an established treatment regimen for CLL in the front-line and R/R settings
Idelalisib plus bendamustine and rituximab (BR) is superior to BR alone in patients with relapsed/refractory CLL: Results of a phase III randomized double-blind placebo-controlled study Andrew D. Zelenetz,
More informationCisplatin plus Gemcitabine versus Gemcitabine for Biliary Tract Cancer. Valle J et al. N Engl J Med 2010;362(14):
Cisplatin plus Gemcitabine versus Gemcitabine for Biliary Tract Cancer Valle J et al. N Engl J Med 2010;362(14):1273-81. Introduction > Biliary tract cancers (BTC: cholangiocarcinoma, gall bladder cancer,
More informationKEYTRUDA is also indicated in combination with pemetrexed and platinum chemotherapy for the
FDA-Approved Indication for KEYTRUDA (pembrolizumab) in Combination With Carboplatin and Either Paclitaxel or Nab-paclitaxel for the Firstline Treatment of Patients With Metastatic Squamous Non Small Cell
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 informationMONALESSA-7: Phase III placebo-controlled study of ribociclib and tamoxifen/nsai + goserelin
First-line ribociclib or placebo combined with goserelin and tamoxifen or a non-steroidal aromatase inhibitor in premenopausal women with hormone receptor-positive, HER2-negative advanced breast cancer:
More informationGourgou-Bourgade, et al DOI: /JCO
Impact of FOLFIRINO compared with gemcitabine on Quality-of-Life in Patients with Metastatic Pancreatic Cancer: results from the PRODIGE 4/ACCORD 11 randomized trial Gourgou-Bourgade, et al DOI: 10.1200/JCO.2012.44.4869
More informationPlattenepithelkarzinom des Ösophagus, 1 st -line
Plattenepithelkarzinom des Ösophagus, 1 st -line AIO-STO-0309 An open-label, randomized phase III trial of cisplatin and 5-fluorouracil with or without panitumumab for patients with nonresectable, advanced
More informationM Y ELO I D D I FFER ENTIATI O N OPENS UP THE POSSIBILITIES
IDHIFA (enasidenib) is indicated for the treatment of adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an
More information290O - Patient-reported outcomes (PROs) in advanced breast cancer (ABC) treated with ribociclib + fulvestrant: results from MONALEESA-3
290O - Patient-reported outcomes (PROs) in advanced breast cancer (ABC) treated with ribociclib + fulvestrant: results from MONALEESA-3 Presentation Number: 290O Lecture Time: 11:18-11:33 Speakers: Peter
More informationSponsor Novartis Pharma GmbH. Generic Drug Name Panobinostat (LBH589) Therapeutic Area of Trial Myelodysplastic Syndrome (MDS)
Sponsor Novartis Pharma GmbH Generic Drug Name Panobinostat (LBH589) Therapeutic Area of Trial Myelodysplastic Syndrome (MDS) Approved Indication Investigational Protocol Number CLBH589BDE04 Title A one
More informationManaging Acromegaly: Review of Two Cases
Managing Acromegaly: Review of Two Cases INDICATION AND USAGE SIGNIFOR LAR (pasireotide) for injectable suspension is a somatostatin analog indicated for the treatment of patients with acromegaly who have
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 informationTKIs ( Tyrosine Kinase Inhibitors ) Mechanism of action and toxicity in CML Patients. Moustafa Sameer Hematology Medical Advsior,Novartis oncology
TKIs ( Tyrosine Kinase Inhibitors ) Mechanism of action and toxicity in CML Patients Moustafa Sameer Hematology Medical Advsior,Novartis oncology Introduction In people with chronic myeloid leukemia, A
More informationStudy Period: 27 March 2008 (first subject enrolled) to 05 May 2010 (data cutoff date for primary analysis)
Date: 20 July 2011 Page 2 of 3375 2. SYNOPSIS Name of Sponsor: mgen Inc., Thousand Oaks, C US Name of Finished Product: Not applicable Name of ctive Ingredient: Ganitumab (MG 479) Title of Study: n International,
More informationSYNOPSIS PROTOCOL TALBOT
SYNOPSIS PROTOCOL TALBOT A) CLINICAL TRIAL IDENTIFICATION SPONSOR - PROTOCOL CODE NUMBER : VERSION: SYNOPSIS V4.0-30/06/2015 TRIAL TITLE : Open-label, randomized, multicenter, phase II study, comparing
More informationPresented on Friday April 5, 2018 (Invited Oral Presentation)
RIBOCICLIB PLUS GOSERELIN AND TAMOXIFEN OR A NON-STEROIDAL AROMATASE INHIBITOR FOR PREMENOPAUSAL WOMEN WITH HR+, HER2 ADVANCED BREAST CANCER IN THE RANDOMIZED PHASE III MONALEESA-7 TRIAL Seock-Ah Im, 1
More informationCelgene Receives Positive CHMP Opinion for ABRAXANE in Combination with Gemcitabine as Treatment for Patients with Metastatic Pancreatic Cancer
November 22, 2013 Celgene Receives Positive CHMP Opinion for ABRAXANE in Combination with Gemcitabine as Treatment for Patients with Metastatic Pancreatic Cancer BOUDRY, Switzerland--(BUSINESS WIRE)--Celgene
More informationPRODUCT INFORMATION (as succinate) and (as free base)
KISQALI TABLETS NAME OF THE MEDICINE PRODUCT INFORMATION Active ingredient: Chemical name: ribociclib succinate butanedioic acid - 7-cyclopentyl-N,N-dimethyl-2-{[5-(piperazin-1-yl) pyridin-2-yl]amino}-7h-pyrrolo[2,3-d]pyrimidine-6-carboxamide
More informationTIPS FOR GETTING THE MOST OUT OF YOUR TREATMENT.
Keeping it Real. TIPS FOR GETTING THE MOST OUT OF YOUR TREATMENT. Guiding you through your treatment Taking KISQALI (ribociclib) as prescribed is essential to getting the most out of your treatment. That
More informationPRODUCT INFORMATION 1 ABOUT THIS GUIDE DOSAGE FORM AND STRENGTH STORAGE AND HANDLING
DOSING GUIDE INDICATION ONIVYDE (irinotecan liposome injection) is indicated, in combination with fluorouracil (5-FU) and leucovorin (LV), for the treatment of patients with metastatic adenocarcinoma of
More informationPanobinostat, Bortezomib and Dexamethasone
Panobinostat, Bortezomib and Dexamethasone Indication Treatment of relapsed/refractory multiple myeloma in patients who have received at least 2 prior regimens, including bortezomib and an immunomodulatory
More informationCDK 4/6 Inhibitors: Efficacy and Side Effect Profile
CDK 4/6 Inhibitors: Efficacy and Side Effect Profile Univ.-Prof. Dr. Christian F Singer, MPH Center for Breast Health, Medical University of Vienna Center for Familial Breast- and Ovarian Cancer, MUW Christian
More informationFDA Approves ABRAXANE for the First-Line Treatment of Advanced Non-Small Cell Lung Cancer
October 12, 2012 FDA Approves ABRAXANE for the First-Line Treatment of Advanced Non-Small Cell Lung Cancer Approval Based on Significantly Improved Overall Response Rates in all Patients Regardless of
More informationAquila Smoldering Multiple Myeloma
Inklusionskriterier: Ja Nej 1. At least 18 years of age or at least the legal age of consent in the jurisdiction in which the study is taking place, whichever is the older age. 2. Diagnosis of SMM for
More informationALECENSA (alectinib) Fact Sheet
ALECENSA (alectinib) Fact Sheet What is NSCLC? ALECENSA is a kinase inhibitor approved for the treatment of people with anaplastic lymphoma kinase (ALK)-positive, metastatic non-small cell lung cancer
More informationSupplementary Appendix
Supplementary Appendix This appendix has been provided by the authors to give readers additional information about their work. Supplement to: Maemondo M, Inoue A, Kobayashi K, et al. Gefitinib or chemotherapy
More informationhttps://clinicaltrials.gov/ct2/show/nct ?term=inge-b&rank=1
Seite 1 von 6 A service of the U.S. National Institutes of Health Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting Trial record 1 of 1 for: INGE-B Previous Study Return
More informationFDA Approves Opdivo (nivolumab) for the Treatment of Patients with Previously Treated Metastatic Squamous Non-Small Cell Lung Cancer
March 5, 2015 FDA Approves Opdivo (nivolumab) for the Treatment of Patients with Previously Treated Metastatic Squamous Non-Small Cell Lung Cancer (PRINCETON, NJ, March 4, 2015) Bristol-Myers Squibb Company
More informationBackground CPX-351. Lancet J, et al. J Clin Oncol. 2017;35(suppl): Abstract 7035.
Overall Survival (OS) With Versus in Older Adults With Newly Diagnosed, Therapy-Related Acute Myeloid Leukemia (taml): Subgroup Analysis of a Phase 3 Study Abstract 7035 Lancet JE, Rizzieri D, Schiller
More informationClinical Study Synopsis
Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace
More informationPATIENT GUIDE. Highlights of Important Safety Information Warnings and Precautions. Your guide to treatment with Signifor LAR for acromegaly
PATIENT GUIDE Your guide to treatment with Signifor LAR for acromegaly Signifor LAR is indicated for the treatment of patients with acromegaly for whom surgery has not worked well enough or who cannot
More informationSupplementary Online Content
Supplementary Online Content Jänne PA, van den Heuvel MM, Barlesi F, et al. Effect of selumetinib plus docetaxel compared with docetaxel alone and progression-free survival in patients with KRASmutant
More informationThe issues that will be resolved through PMCs include the the requalification of bioburden test.
BLA 125409/0_ Perjeta (pertuzumab) 4 patients with normal renal function. No dose adjustment can be recommended for patients with severe renal impairment because of the limited pharmacokinetic data available.
More informationEvolving Paradigms in HER2+ MBC: Strategies for Individualizing Therapy with Available Agents
Evolving Paradigms in HER2+ MBC: Strategies for Individualizing Therapy with Available Agents Kimberly L. Blackwell MD Professor Department of Medicine and Radiation Oncology Duke University Medical Center
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 informationNerlynx (neratinib) NEW PRODUCT SLIDESHOW
Nerlynx (neratinib) NEW PRODUCT SLIDESHOW Introduction Brand name: Nerlynx Generic name: Neratinib Pharmacological class: Kinase inhibitor Strength and Formulation: 40mg; tabs Manufacturer: Puma Biotechnology
More informationImmune checkpoint blockade in lung cancer
Immune checkpoint blockade in lung cancer Raffaele Califano Department of Medical Oncology The Christie and University Hospital of South Manchester, Manchester, UK Outline Background Overview of the data
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 informationTrabectedin in ASTS. Le Cesne A, et al. J Clin Oncol. 2018;36(suppl): Abstract
Results of a Prospective Randomized Phase III T-SAR Trial Comparing Trabectedin vs Best Supportive Care (BSC) in Patients With Pretreated Advanced Soft Tissue Sarcoma (ASTS) Abstract 11508 Le Cesne A,
More informationANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked
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 informationPertuzumab for the adjuvant treatment of HER2-positive breast cancer
Lead team presentation Pertuzumab for the adjuvant treatment of HER2-positive breast cancer 1 st Appraisal Committee meeting Background and clinical effectiveness Committee A Lead team: John McMurray,
More informationThis was a multi-center study conducted at 44 study centers. There were 9 centers in the United States and 35 centers in Europe.
Protocol CAM307: A Phase 3 Study to Evaluate the Efficacy and Safety of Frontline Therapy with Alemtuzumab (Campath ) vs Chlorambucil in Patients with Progressive B-Cell Chronic Lymphocytic Leukemia These
More informationTechnology appraisal guidance Published: 20 December 2017 nice.org.uk/guidance/ta496
Ribociclib with an aromatase inhibitor for previously untreated, hormone receptor- positive, HER2-negative, e, locally advanced or metastatic breast cancer Technology appraisal guidance Published: 20 December
More informationNivolumab in Patients With DNA Mismatch Repair Deficient/Microsatellite Instability High Metastatic Colorectal Cancer: Update From CheckMate 142
Nivolumab in Patients With DNA Mismatch Repair Deficient/Microsatellite Instability High Metastatic Colorectal Cancer: Update From CheckMate 142 Abstract #519 Overman MJ, Lonardi S, Leone F, McDermott
More informationImmunoconjugates in Both the Adjuvant and Metastatic Setting
Immunoconjugates in Both the Adjuvant and Metastatic Setting Mark Pegram, M.D. Director, Stanford Breast Oncology Program Co-Director, Molecular Therapeutics Program Trastuzumab Treatment of Breast Tumor
More informationInibitori delle chinasi ciclino dipendenti nel trattamento della malattia metastatica HR-positiva Gli studi clinici
Inibitori delle chinasi ciclino dipendenti nel trattamento della malattia metastatica HR-positiva Gli studi clinici Laura Orlando UOC Oncologia & Breast Unit Brindisi Verona 22/04/2016 Summary Studi con
More informationSummary of the risk management plan (RMP) for Tagrisso (osimertinib)
EMA/2497/2016 Summary of the risk management plan (RMP) for Tagrisso (osimertinib) This is a summary of the risk management plan (RMP) for Tagrisso, which details the measures to be taken in order to ensure
More informationUpdate on New Perspectives in Endocrine-Sensitive Breast Cancer. James R. Waisman, MD
Update on New Perspectives in Endocrine-Sensitive Breast Cancer James R. Waisman, MD Nothing to disclose DISCLOSURE TAILORx Oncotype Recurrence Score TAILORx Study Design Sparano, J Clin Oncol 2008;26:721-728
More informationCAPRELSA (vandetanib) Tablets and Risk of QT Prolongation, Torsades de Pointes and Sudden Death
CAPRELSA (vandetanib) Tablets and Risk of QT Prolongation, Torsades de Pointes and Sudden Death Prescriber Training Pamphlet Introduction This training pamphlet has been developed as part of a REMS program
More informationChemotherapy for Advanced Gastric Cancer
Chemotherapy for Advanced Gastric Cancer Andrés Cervantes Professor of Medicine DISCLOSURE OF INTEREST Employment: None Consultant or Advisory Role: Merck Serono, Roche, Beigene, Bayer, Servier, Lilly,
More informationpan-canadian Oncology Drug Review Final Clinical Guidance Report Everolimus (Afinitor) for Advanced Breast Cancer March 25, 2013
pan-canadian Oncology Drug Review Final Clinical Guidance Report Everolimus (Afinitor) for Advanced Breast Cancer March 25, 2013 DISCLAIMER Not a Substitute for Professional Advice This report is primarily
More information