Our Clinical Trials. Oncology

Size: px
Start display at page:

Download "Our Clinical Trials. Oncology"

Transcription

1 Our Clinical Trials Oncology

2 ANGIOGENESIS Trebananib (AMG 86) (angiopoietin inhibitor) ANTIBODY DRUG CONJUGATE, continued AMG 595 (anti-egfrviii) Trebananib With Paclitaxel and Trastuzumab or Capecitabine and Lapatinib in HER-Positive b Glioma First-In-Human Study of AMG Trebananib Plus Paclitaxel With or Without Bevacizumab as First-Line in HER-Negative Trebananib in Combination With FOLFIRI Hepatic Trebananib in Combination With Cisplatin & Capecitabine First-line Therapy of Trebananib in Combination With Sorafenib Trebananib with Pemetrexed and Carboplatin in Open-Label First-line Therapy of Trebananib With Paclitaxel and Carboplatin Trebananib in Combination With Pegylated Liposomal Doxorubicin or Topotecan TRINOVA-: Trebananib in Combination With Paclitaxel in Recurrent Cancer TRINOVA-: Trebananib in Combination With Paclitaxel/Carboplatin in First-Line Therapy b/ Renal Trebananib in Combination With Sunitinib b b BONE METASTASES AND METABOLISM Denosumab (RANK ligand inhibitor) Giant Cell Tumor Multiple Myeloma Prostate CELL CYCLE Denosumab Study in Adjuvant Cancer (D-CARE) Placebo-Controlled Study of Denosumab in Patients Receiving Aromatase Inhibitor Therapy Denosumab in Recurrent or Unresectable Giant Cell Tumor of the Bone Denosumab Compared to Zoledronic Acid for Treatment of Bone Disease in Multiple Myeloma Denosumab Study on Lens Opacifications in Non-Metastatic Patients on ADT and Denosumab in the Treatment of Hypercalcemia Multiple Myeloma of Malignancy AMG 900 (pan-aurora kinase inhibitor) AMG 780 (angiopoietin inhibitor) Trebananib Pharmacokinetics in Cancer Subjects With Normal and Impaired Renal Function Trebananib With Either Motesanib, Bevacizumab, Sorafenib, or Sunitinib AMG 780 First-In-Human Study in Adult Subjects with Advanced ANTIBODY DRUG CONJUGATE AMG 7 (antibody drug conjugate) b Renal First-in-Human Study of AMG 7 in Patients with Kidney Cancer GROWTH REGULATION Rilotumumab (HGF/SF inhibitor) AMG 900 in Adult Subjects With Acute s and Related Disorders AMG 900 First-In-Human Study in Adult Subjects With Advanced Prostate SCLC Rilotumumab or Ganitumab in Combination With Panitumumab Rilotumumab in Combination With Epirubicin, Cisplatin, and Capecitabine RILOMET-: Rilotumumab with ECX in First- Line Treatment for MET-Positive Lower, or GEJ Adenocarcinoma Rilotumumab in Combination With Mitoxantrone and Prednisone Rilotumumab or Ganitumab in Combination With Cisplatin or Carboplatin, and Etoposide b/ b/ b/ b/

3 GROWTH REGULATION, continued AMG 08 (MET inhibitor) GROWTH REGULATION, continued Panitumumab (EGFR inhibitor), continued First-In-Human Study of AMG Panitumumab Pediatric Study AMG 9 (PIKδ inhibitor) Lymphoma AMG 7 (MET inhibitor) AMG 9 First-in-Human Study in Adult Subjects with Lymphoid Malignancy First-in-Human Study of AMG 7 Ganitumab (IGFR antagonist) SCLC Panitumumab (EGFR inhibitor) Panitumumab Plus Irinotecan Followed by Panitumumab Plus Ganitumab Ganitumab or Rilotumumab (AMG 0) in Combination With Cisplatin or Carboplatin, and Etoposide b/ SPIRITT: Second-line Therapy of Panitumumab or Bevacizumab in Combination With FOLFIRI PEAK: First-line Therapy of Panitumumab or Bevacizumab in Combination With mfolfox6 Panitumumab Plus Irinotecan Followed by Panitumumab Plus Ganitumab (AMG 479) Panitumumab With Best Supportive Care (BSC) vs BSC Alone ASPECCT: Panitumumab Efficacy and Safety Compared to Cetuximab in Subjects With WT KRAS mcrc PRISM: Second-line Therapy With Panitumumab CONCERT: Radiotherapy Plus Panitumumab Compared to Chemoradiotherapy PARTNER: Cisplatin and Docetaxel With or Without Panitumumab Pharmacokinetic Study of Chemotherapy With or Without Panitumumab HEMATOPOIESIS Darbepoetin alfa (erythropoiesis-stimulating agent) MDS Other Clinical Trials Darbepoetin alfa for the Treatment of Anemic Subjects With Low or Intermediate- Risk MDS Impact of Darbepoetin alfa on Survival in Anemic Subjects Receiving Chemotherapy Pegfilgrastim (granulocyte colony-stimulating factor) Romiplostim (thrombopoiesis stimulator) MDS FN NOLAN: The Effect of Prophylactic Naproxen or Loratidine on Bone Pain with Chemotherapy and Pegfilgrastim RIAN: The Effect of Patient Education on Reported Bone Pain with Chemotherapy and Pegfilgrastim PAVES: Placebo-Controlled Study of Pegfilgrastim With Bevacizumab and Either FOLFOX or FOLFIRI Interventional Study in Adult Subjects with Receiving Romiplostim Long-term Dosing of Romiplostim in Thrombocytopenic Pediatric Subjects With Safety and Efficacy Study of Romiplostim to Treat in Pediatric Subjects Placebo-Controlled Study of Romiplostim (All subjects have been removed from treatment and are being followed for observation) Study to Investigate the Relationship Between Physician-Assessed Febrile Neutropenia (FN) Risk Probability Score and Prediction Tool FN Risk Probability Score for Patients With Non-Myeloid Malignancies n/a

4 IMMUNOTHERAPY Blinatumomab (bispecific T cell engager antibody) Blinatumomab in Pediatric and Adolescent Patients With Relapsed/Refractory B-Precursor Acute Lymphoblastic Blinatumomab in Patients With Minimal Residual Disease of B-Precursor Acute Lymphoblastic Blinatumomab in Patients With Relapsed/ Refractory B-Precursor Acute Lymphoblastic b/ Amgen s Research and Development Vision Amgen aspires to be the best human therapeutics company. Amgen is committed to developing new therapies to treat serious illnesses a long and careful process. Among the most important steps in this process are the clinical trials, where people volunteer to receive an experimental new drug or procedure and be observed for its effects. Blinatumomab in Adult Patients With Relapsed/ Refractory B-Precursor Acute Lymphoblastic At Amgen, we apply four guiding principles to our research and development efforts. Non-Hodgkin s Lymphoma Safety Study of Blinatumomab in Patients With Relapsed NHL Talimogene Laherparepvec (oncolytic immunotherapy) The first is to focus on grievous illness. Given the difficulty of successfully developing a new therapy, we focus our efforts on developing therapies to help patients suffering from the greatest unmet medical needs. Melanoma TUMOR ASSOCIATED MACROPHAGES AMG 80 (c-fms inhibitor) OPTiM : Talimogene Laherparepvec Compared to GM-CSF in Unresectable Melanoma Our second guiding principle is to be modality independent. Small molecules and biotherapeutics (biologics) each have unique and inherent advantages and disadvantages. Our modality independent approach allows us to leverage the advantageous aspects of a particular approach that are best suited to interdict a disease. First-in-Human Study of AMG Our third major emphasis is to study disease in patients. While it is significantly more complicated to study disease in humans, we believe that this is the only way to successfully develop human therapeutics. Information as of /09/. Statements are based on the company s current beliefs and Amgen disclaims any duty to update. For more information about Amgen and its business, including risks and uncertainties, please refer to Amgen s filings with the SEC. Products under investigational study have not been approved by the FDA for the use under investigation. This information is provided only for purposes of providing general information on clinical trials and stages of development on the select candidates identified. This information should not be construed as a recommendation for use of any product for unapproved uses. *For more detailed information about the trial, visit or Previously referred to as OncoVEX GM-CSF Our fourth guiding principle, seamless integration, informs everything we do. There are important insights that come to basic research and clinical development from understanding the medical marketplace, and vice versa. Aligning our priorities across these functions ensures that we develop potential therapeutics in a manner that will address unmet medical needs and meet the changing demands of the marketplace. OPTiM = OncoVEX GM-CSF Pivotal Trial In Melanoma.

5 Amgen Inc. One Amgen Center Drive Thousand Oaks, CA Amgen Inc. All Rights Reserved. 68-R-V

IRB INDICATION Number ENROLLED

IRB INDICATION Number ENROLLED Revised 1/6/2011 OPEN TRIALS 2006-2011 INDICATION Number ENROLLED SPONSOR Title Provided Phase I AZA PH US 2007 PK 006 Celgene A Phase I, Open-Label, Multi-Center, Parallel Group Study to Assess the Pharmacokinetics

More information

Xgeva. Xgeva (denosumab) Description

Xgeva. Xgeva (denosumab) Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.30.18 Subject: Xgeva Page: 1 of 5 Last Review Date: March 16, 2018 Xgeva Description Xgeva (denosumab)

More information

National Cancer Drugs Fund List - Approved

National Cancer Drugs Fund List - Approved National Cancer Drugs Fund List - Approved DRUG Abiraterone Aflibercet Albumin Bound Paclitaxel Axitinib CDF INDICATION (EXCLUDING APPROVED CRITERIA ) Metastatic Prostate Cancer Metastatic Colorectal Cancer

More information

Commissioning policies agreed by PCTs in Yorkshire and the Humber at Board meeting of YH SCG on December

Commissioning policies agreed by PCTs in Yorkshire and the Humber at Board meeting of YH SCG on December Commissioning policies agreed by PCTs in Yorkshire and the Humber at Board meeting of YH SCG on December 17 2010. 32/10 Imatinib for gastrointestinal stromal tumours (unresectable/metastatic) (update on

More information

The Royal Marsden NHS Foundation Trust Medicines Formulary. NICE register for medicines initiated at the trust. Type and code. Publication.

The Royal Marsden NHS Foundation Trust Medicines Formulary. NICE register for medicines initiated at the trust. Type and code. Publication. NICE register for medicines initiated at the trust. CG denotes Clinical Guideline TA denotes Technical Appraisal For further information about NICE and full guidelines please refer to www.nice.org.uk Title

More information

NCIC CLINICAL TRIALS GROUP DATA SAFETY MONITORING COMMITTEE Fall Conference Call 23 November 2009 SUMMARY REPORT

NCIC CLINICAL TRIALS GROUP DATA SAFETY MONITORING COMMITTEE Fall Conference Call 23 November 2009 SUMMARY REPORT NCIC CLINICAL TRIALS GROUP DATA SAFETY MONITORING COMMITTEE Fall Conference Call 23 November 2009 SUMMARY REPORT The NCIC CTG DSMC reviewed the following trials with respect to safety, trial conduct, including

More information

Vectibix. Vectibix (panitumumab) Description

Vectibix. Vectibix (panitumumab) Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.21.85 Subject: Vectibix Page: 1 of 5 Last Review Date: December 2, 2016 Vectibix Description Vectibix

More information

CENTER FOR CLINICAL TRIALS St. Luke s Medical Center. Ongoing Clinical Trials CANCER INSTITUTE (36)

CENTER FOR CLINICAL TRIALS St. Luke s Medical Center. Ongoing Clinical Trials CANCER INSTITUTE (36) CENTER FOR CLINICAL TRIALS St. Luke s Medical Center Ongoing Clinical Trials CANCER INSTITUTE (36) BLOOD TITLE : A Randomized, Two By Two Arm, Multicenter, Open-Label Phase III Study Of BMS-354825 Administered

More information

Erbitux. Erbitux (cetuximab) Description

Erbitux. Erbitux (cetuximab) Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.21.84 Subject: Erbitux Page: 1 of 6 Last Review Date: December 2, 2016 Erbitux Description Erbitux (cetuximab)

More information

An D. Nguyen, MD Curriculum Vitae

An D. Nguyen, MD Curriculum Vitae OFFICE/ BUSINESS ADDRESS: Pacific Shores Medical Group 19582 Beach Blvd, Suite 212 Huntington Beach, CA 92648 Phone: (714) 252-9415 Fax: (714) 963-8407 ADDITIONAL OFFICE: 16300 Sand Canyon Avenue, Suite

More information

SUPPLEMENTARY INFORMATION

SUPPLEMENTARY INFORMATION SUPPLEMENTARY NFORMATON n format provided by Melero et al. (AUGUST 2015) Supplementary nformation S3 Combinations including two or more immunotherapy agents based on PD-1/PD-L1 blockade. (Source: https://clinicaltrials.gov/

More information

NCIC CLINICAL TRIALS GROUP DATA SAFETY MONITORING COMMITTEE Friday, 1 May 2009 SUMMARY REPORT

NCIC CLINICAL TRIALS GROUP DATA SAFETY MONITORING COMMITTEE Friday, 1 May 2009 SUMMARY REPORT NCIC CLINICAL TRIALS GROUP DATA SAFETY MONITORING COMMITTEE Friday, 1 May 2009 SUMMARY REPORT The NCIC CTG DSMC reviewed the following trials with respect to safety, trial conduct, including accrual, and

More information

University of Groningen. Health economics of targeted cancer therapies Mihajlovic, Jovan

University of Groningen. Health economics of targeted cancer therapies Mihajlovic, Jovan University of Groningen Health economics of targeted therapies Mihajlovic, Jovan IMPORTANT NOTE: You are advised to consult the publisher's version (publisher's PDF) if you wish to cite from it. Please

More information

WASHINGTON. Spokane Cheney. Olympia. Tri-Cities. Walla Walla. Portland North Central Oregon City OREGON. Mt. Vernon. Port Angeles

WASHINGTON. Spokane Cheney. Olympia. Tri-Cities. Walla Walla. Portland North Central Oregon City OREGON. Mt. Vernon. Port Angeles 2 3 Mt. Vernon Port Angeles Bremerton Tacoma 5 5 Olympia Everett Edmonds Seattle 90 WASHINGTON 90 Spokane Cheney Pullman Longview 82 Tri-Cities Portland North Central Oregon City 5 84 OREGON Walla Walla

More information

Xgeva. Xgeva (denosumab) Description. Section: Prescription Drugs Effective Date: January 1, 2016

Xgeva. Xgeva (denosumab) Description. Section: Prescription Drugs Effective Date: January 1, 2016 Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.07.18 Subject: Xgeva Page: 1 of 5 Last Review Date: December 3, 2015 Xgeva Description Xgeva (denosumab)

More information

The following slides are provided as presented by the author during the live educa7onal ac7vity and are intended for reference purposes only.

The following slides are provided as presented by the author during the live educa7onal ac7vity and are intended for reference purposes only. The following slides are provided as presented by the author during the live educa7onal ac7vity and are intended for reference purposes only. If you have any ques7ons, please contact Imedex via email at:

More information

Cancer drug approvals for paediatric indications (n=43)

Cancer drug approvals for paediatric indications (n=43) Appendix: Supplementary material [posted as supplied by author] Figure A. Identification of cohort of drugs Total number of antineoplastic and immunomodulating products approved by the EMA up to 31 December

More information

Pharmacy Medical Necessity Guidelines: Neulasta (pegfilgrastim)

Pharmacy Medical Necessity Guidelines: Neulasta (pegfilgrastim) Pharmacy Medical Necessity Guidelines: Effective: October 1, 2017 Prior Authorization Required Type of Review Care Management Not Covered Type of Review Clinical Review Pharmacy (RX) or Medical (MED) Benefit

More information

The Royal Marsden NHS Foundation Trust Medicines Formulary. NICE register for medicines initiated at the trust. Type and code. Publication.

The Royal Marsden NHS Foundation Trust Medicines Formulary. NICE register for medicines initiated at the trust. Type and code. Publication. NICE register for medicines initiated at the trust. CG denotes Clinical Guideline TA denotes Technical Appraisal For further information about NICE and full guidelines please refer to www.nice.org.uk Title

More information

CURRENTLY ENROLLING ONCOLOGY TREATMENT STUDIES (as of 4/27/2017)

CURRENTLY ENROLLING ONCOLOGY TREATMENT STUDIES (as of 4/27/2017) CURRENTLY ENROLLING ONCOLOGY TREATMENT STUDIES (as of 4/27/2017) Leukemia AALL0932 closed after Induction Treatment of Patients with Newly Diagnosed Standard Risk B-Lymphoblastic Leukemia (B-ALL) or Localized

More information

Third Line and Beyond: Management of Refractory Colorectal Cancer

Third Line and Beyond: Management of Refractory Colorectal Cancer Third Line and Beyond: Management of Refractory Colorectal Cancer George A. Fisher MD PhD Stanford University 1 Overview Defining the chemo refractory and intolerant Agents approved in 3 rd line setting

More information

Docetaxel. Class: Antineoplastic agent, Antimicrotubular, Taxane derivative.

Docetaxel. 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 information

Roche setting the standards of cancer care Oncology Event for Investors, June 19

Roche setting the standards of cancer care Oncology Event for Investors, June 19 Roche setting the standards of cancer care Oncology Event for Investors, June 19 Kapil Dhingra, VP Medical Science Developing a drug to the standard of care Superior clinical benefit, resources and time

More information

London Cancer New Drugs Group. February London Cancer New Drugs Group (LCNDG) Work Plan for the London Cancer Drugs Fund list.

London Cancer New Drugs Group. February London Cancer New Drugs Group (LCNDG) Work Plan for the London Cancer Drugs Fund list. February 2013 London Cancer New s Group (LCNDG) Work Plan for the London Cancer s Fund London Cancer s Fund List This Cancer s Fund (CDF) list of medicines and s is in two parts. 1. The standard list of

More information

Esophageal and GEJ Cancers. Case Presentations

Esophageal and GEJ Cancers. Case Presentations Esophageal and GEJ Cancers Case Presentations Locally Advanced GEJ Cancer (Case 1) A 55 year old man with longstanding GERD presents with increasing solid food dysphagia. EGD reveals a 3 cm mass in the

More information

Systemic Cytotoxic Therapy in advanced HCC

Systemic Cytotoxic Therapy in advanced HCC Systemic Cytotoxic Therapy in advanced HCC Yeul Hong Kim Korea University Anam Hospital Cancer Center Hepatocellular Carcinoma : Overview Epidemiology Current Guideline : advanced HCC Cytotoxic Chemotherapy

More information

The Clinical Research E-News

The Clinical Research E-News Volume 3: ISSUE 3: February 16, 2011 The Clinical Research E-News Now Open: RTOG 0631, Phase II/III Study of Image-Guided Radiosurgery/SBRT for Localized Spine Metastasis RTOG 1010, A Phase III Trial Evaluating

More information

Avastin (bevacizumab) DRUG.00028, CG-DRUG-68

Avastin (bevacizumab) DRUG.00028, CG-DRUG-68 Avastin (bevacizumab) DRUG.00028, CG-DRUG-68 Override(s) Prior Authorization Approval Duration 1 year Medications Avastin (bevacizumab) APPROVAL CRITERIA Requests for Avastin (bevacizumab) may be approved

More information

NICE-approved drugs for specialities which fall outside of the services currently provided by the Trust

NICE-approved drugs for specialities which fall outside of the services currently provided by the Trust NICE-approved drugs for specialities which fall outside of the services currently provided by the Trust Drug NICE-approved use NICE TA link Abiraterone Abiraterone Adalimumab Adalimumab Adalimumab Adefovir

More information

Active Cancer Studies by Approval Date For additional information on any one of these studies contact the Lancaster General Cancer Center

Active Cancer Studies by Approval Date For additional information on any one of these studies contact the Lancaster General Cancer Center Active Cancer Studies by Approval Date For additional information on any one of these studies contact the Lancaster General Cancer Center 717-544-3113 PROTOCOL NO STUDY TITLE PRINCIPAL INVESTIGATOR ECOG

More information

Azacitidine Vidaza Non-transplant myelodysplastic syndrome Funded Funded Funded Funded Funded Funded Not Funded

Azacitidine Vidaza Non-transplant myelodysplastic syndrome Funded Funded Funded Funded Funded Funded Not Funded Provincial Fundin Summary The interim Joint Oncoloy Dru Review (ijodr) was the precursor oncoloy dru review process prior to pcodr, which provided evidence-based recommendation for cancer treatments from

More information

CLINICAL TRIALS ACC. Jul 2016

CLINICAL TRIALS ACC. Jul 2016 CLINICAL TRIALS ACC Jul 2016 Glioblastoma BRAIN A071102 A Phase II/III Randomized Trial of Veliparib or Placebo in Combination With Temozolomide in Newly Diagnosed Glioblastoma With MGMT Promoter Hypermethylation

More information

PEDIATRIC. BRAIN ACNS 0332: Efficacy of Carboplatin Administered Concomitantly with Radiation and Isotretinoin as a COMPANION STUDIES

PEDIATRIC. BRAIN ACNS 0332: Efficacy of Carboplatin Administered Concomitantly with Radiation and Isotretinoin as a COMPANION STUDIES PEDIATRIC BRAIN ACNS 0332: Efficacy of Carboplatin Administered Concomitantly with Radiation and Isotretinoin as a Pro-Apoptotic Agent in other than Average Risk Medulloblastoma/PNET Patients. https://clinicaltrials.gov/ct2/show/nct00392327?term=0332&rank=6

More information

Clinical Impact of primary prophylaxis for FN in breast cancer patients. Prof. Young Jin Suh The Catholic University of Korea

Clinical Impact of primary prophylaxis for FN in breast cancer patients. Prof. Young Jin Suh The Catholic University of Korea Clinical Impact of primary prophylaxis for FN in breast cancer patients Prof. Young Jin Suh The Catholic University of Korea Objectives Describe the prevalence of febrile neutropenia in patients with breast

More information

Cancer: Can we Afford the Cure? Current Trends in Oncology Treatment

Cancer: Can we Afford the Cure? Current Trends in Oncology Treatment Cancer: Can we Afford the Cure? Current Trends in Oncology Treatment Julie Kennerly-Shah, PharmD, MS, MHA, BCPS May 30, 2018 The Ohio State University Comprehensive Cancer Center Arthur G. James Cancer

More information

CancerPACT Cancer Patients Alliance for Clinical Trials

CancerPACT Cancer Patients Alliance for Clinical Trials TM CancerPACT Cancer Patients Alliance for Clinical Trials Listing of Ongoing Cancer Clinical Trials in the Salinas Valley Winter 2008 I. Solid Tumors 1. Breast p.1 2. Central Nervous System p.2 3. Gastrointestinal

More information

MEDICAL PRIOR AUTHORIZATION

MEDICAL PRIOR AUTHORIZATION MEDICAL PRIOR AUTHORIZATION TAXOTERE (docetaxel) DOCEFREZ(docetaxel) docetaxel (generic) POLICY I. INDICATIONS The indications below including FDA-approved indications and compendial uses are considered

More information

Personalised Medicine

Personalised Medicine Personalised Medicine Panacea or Pandora s box? Dr Tom Lillie Oncology Therapeutic Area Head Amgen October 2012 Amgen is the world s leading biotechnology company employs more than 17,000 staff in 39 countries

More information

Treatment Options for Breast Cancer in Low- and Middle-Income Countries: Adjuvant and Metastatic Systemic Therapy

Treatment Options for Breast Cancer in Low- and Middle-Income Countries: Adjuvant and Metastatic Systemic Therapy Women s Empowerment Cancer Advocacy Network (WE CAN) Conference Bucharest, Romania October 2015 Treatment Options for Breast Cancer in Low- and Middle-Income Countries: Adjuvant and Metastatic Systemic

More information

CURRENTLY ENROLLING ONCOLOGY TREATMENT STUDIES (as of )

CURRENTLY ENROLLING ONCOLOGY TREATMENT STUDIES (as of ) Leukemia AALL0932 closed after Induction CURRENTLY ENROLLING ONCOLOGY TREATMENT STUDIES (as of 10.10.2017) Treatment of Patients with Newly Diagnosed Standard Risk B-Lymphoblastic Leukemia (B-ALL) or Localized

More information

Policy. Medical Policy Manual Approved Revised: Do Not Implement until 6/30/2019. Nivolumab

Policy. Medical Policy Manual Approved Revised: Do Not Implement until 6/30/2019. Nivolumab Medical Manual Approved Revised: Do Not Implement until 6/30/2019 Nivolumab NDC CODE(S) 00003-3772-XX Opdivo 40 MG/4ML SOLN (B-M SQUIBB U.S. (PRIMARY CARE)) 00003-3774-XX Opdivo 100 MG/10ML SOLN (B-M SQUIBB

More information

Haematology, Oncology and Palliative Care Directorate.

Haematology, Oncology and Palliative Care Directorate. Anticancer Treatment for Administration on the Somerset Mobile Chemotherapy Unit The table below details the suitability of different types of anticancer treatment for administration on the Somerset Mobile

More information

Cyramza (ramucirumab)

Cyramza (ramucirumab) Cyramza (ramucirumab) Line(s) of Business: HMO; PPO; QUEST Integration Akamai Advantage Original Effective Date: 10/01/2015 Current Effective Date: 03/01/2017TBD03/01/2018 POLICY A. INDICATIONS The indications

More information

Index. Note: Page numbers of article titles are in boldface type.

Index. Note: Page numbers of article titles are in boldface type. Index Note: Page numbers of article titles are in boldface type. A Abdominal drainage, after hepatic resection, 159 160 Ablation, radiofrequency, for hepatocellular carcinoma, 160 161 Adenocarcinoma, pancreatic.

More information

Policy. Medical Policy Manual Approved Revised: Do Not Implement Until 3/2/19. Nivolumab (Intravenous)

Policy. Medical Policy Manual Approved Revised: Do Not Implement Until 3/2/19. Nivolumab (Intravenous) Nivolumab (Intravenous) NDC CODE(S) 00003-3772-XX Opdivo 40 MG/4ML SOLN (B-M SQUIBB U.S. (PRIMARY CARE)) 00003-3774-XX Opdivo 100 MG/10ML SOLN (B-M SQUIBB U.S. (PRIMARY CARE)) 00003-3734-XX Opdivo 240

More information

Keytruda. Keytruda (pembrolizumab) Description

Keytruda. Keytruda (pembrolizumab) Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.21.50 Subject: Keytruda Page: 1 of 9 Last Review Date: November 30, 2018 Keytruda Description Keytruda

More information

Working Formulary January 2013 Oncology Chemotherapy Regimens

Working Formulary January 2013 Oncology Chemotherapy Regimens Working Formulary January 2013 Oncology Chemotherapy Regimens In the currently changing commissioning landscape, this document is intended to represent the up to date list of non clinical trial chemotherapy

More information

Currently recruiting trials and/or near future recruitment

Currently recruiting trials and/or near future recruitment Clinical Trials at the Bank of Cyprus Oncology Centre (As of Jan 2018) Currently recruiting trials and/or near future recruitment Development of a module to supplement the EORTC Core instruments for assessment

More information

CancerPACTS. Cancer Patients Alliance for Clinical Trials and Survivorship

CancerPACTS. Cancer Patients Alliance for Clinical Trials and Survivorship CancerPACTS Cancer Patients Alliance for Clinical Trials and Survivorship Listing of Cancer Clinical Trials Silicon Valley area of California Summer / Fall 2011 Solid Tumors 1. Breast. 2 2. Central Nervous

More information

General Information, efficacy and safety data

General Information, efficacy and safety data Horizon Scanning in Oncology Horizon Scanning in Oncology 23 rd Prioritization 2 nd quarter 2015 General Information, efficacy and safety data Eleen Rothschedl Anna Nachtnebel Priorisierung XXIII HSS Onkologie

More information

DOXOrubicin, Cyclophosphamide (AC 60/600) 21 day followed by weekly PACLitaxel (80) Therapy (AC-T) 261 CARBOplatin (AUC4-6) Monotherapy-21 days

DOXOrubicin, Cyclophosphamide (AC 60/600) 21 day followed by weekly PACLitaxel (80) Therapy (AC-T) 261 CARBOplatin (AUC4-6) Monotherapy-21 days Last updated Oct 17, 2018 Tumour Group Protocol Number Protocol Name on NCCP website Breast 200 Trastuzumab (IV) Monotherapy 21 days 201 Trastuzumab (IV) Monotherapy 7 days 202 DOCEtaxel Monotherapy 100mg/m2

More information

Protocol Number Tumour Group Protocol Name on NCCP website 22/02/ Lung Afatinib Monotherapy 244 Gastrointestinal Regorafenib Monotherapy

Protocol Number Tumour Group Protocol Name on NCCP website 22/02/ Lung Afatinib Monotherapy 244 Gastrointestinal Regorafenib Monotherapy Last Updated 22-Feb-18 Date of last update Protocol Number Tumour Group Protocol Name on NCCP website 22/02/2018 221 Afatinib Monotherapy 244 Gastrointestinal Regorafenib Monotherapy 249 Gynaecology Intrathecal

More information

The Clinical Research E-News

The Clinical Research E-News Volume 3: ISSUE 4: March 2, 2011 The Clinical Research E-News Now Open: E1608, A Phase II Trial of GM-CSF Protein Plus Ipilimumab in Patients with Advanced Melanoma E2208, Randomized Phase II Study of

More information

Table Selected Clinical Trials of Anti-Angiogenesis Therapy in Gynecologic Malignancies

Table Selected Clinical Trials of Anti-Angiogenesis Therapy in Gynecologic Malignancies Table Selected Clinical Trials of Anti-Angiogenesis Therapy in Gynecologic Malignancies Uterus Study N Eligibility Regimen RR (No. of Responses) Median OS Grade 3/4 Toxicities Nimeiri et al[42] Total:

More information

Cancer Registry Report. Cancer Focus: Melanoma

Cancer Registry Report. Cancer Focus: Melanoma Cancer Registry Report Cancer Focus: Melanoma In 2005, nearly 60,000 patients were diagnosed with melanoma, resulting in about 7800 deaths Fortunately, melanoma is often diagnosed in an early stage when

More information

See Important Reminder at the end of this policy for important regulatory and legal information.

See Important Reminder at the end of this policy for important regulatory and legal information. Clinical Policy: (Herceptin) Reference Number: ERX.SPA.42 Effective Date: 07.01.16 Last Review Date: 05/17 Line of Business: Commercial [Prescription Drug Plan] Revision Log See Important Reminder at the

More information

The Royal Marsden NHS Foundation Trust Medicines Formulary. NICE register for medicines initiated at the trust. Type and code. Publication.

The Royal Marsden NHS Foundation Trust Medicines Formulary. NICE register for medicines initiated at the trust. Type and code. Publication. NICE register for medicines initiated at the trust. CG denotes Clinical Guideline TA denotes Technical Appraisal For further information about NICE and full guidelines please refer to www.nice.org.uk Title

More information

Vectibix (panitumumab) will be considered medically necessary when all of the following criteria are met:

Vectibix (panitumumab) will be considered medically necessary when all of the following criteria are met: What s New Medical Pharmaceutical Policy November 2017 Updates MBP 40.0 Orencia IV (abatacept)- New Indication Orencia IV (abatacept) will be considered medically necessary when all of the following criteria

More information

CCC Chemotherapy Protocols V9.0

CCC Chemotherapy Protocols V9.0 CCC Chemotherapy Protocols V9.0 General observations 3 Breast cancer 5 Gastrointestinal cancer Oesophagus 17 Gastric 19 Pancreas 22 Cholangiocarcinoma 24 Hepatocellular carcinoma 25 Neuroendocrine tumours

More information

Protocol Number Intrathecal Methotrexate for CNS 01/02/2018 Prophylaxis in GTN Gynaecology 249

Protocol Number Intrathecal Methotrexate for CNS 01/02/2018 Prophylaxis in GTN Gynaecology 249 Last updated Feb 9, 2018 Revision due Protocol Name on NCCP website Tumour Group Protocol Number Intrathecal Methotrexate for CNS 01/02/2018 Prophylaxis in GTN Gynaecology 249 Two Day Etoposide CISplatin

More information

CancerPACT Cancer Patients Alliance for Clinical Trials

CancerPACT Cancer Patients Alliance for Clinical Trials TM CancerPACT Cancer Patients Alliance for Clinical Trials Listing of Ongoing Cancer Clinical Trials in the Sacramento Area Winter 2008 I. Solid Tumors 1. Breast p.1 2. Central Nervous System p.2 3. Gastrointestinal

More information

Clinical Policy: Cetuximab (Erbitux) Reference Number: PA.CP.PHAR.317

Clinical Policy: Cetuximab (Erbitux) Reference Number: PA.CP.PHAR.317 Clinical Policy: (Erbitux) Reference Number: PA.CP.PHAR.317 Effective Date: 01/18 Last Review Date: 11/17 Coding Implications Revision Log Description The intent of the criteria is to ensure that patients

More information

General Authorization Criteria for ALL Agents and Indications:

General Authorization Criteria for ALL Agents and Indications: Neulasta (peg-filgrastim; G-CSF) Neupogen (filgrastim; G-CSF) Neulasta Onpro (peg-filgrastim; G-CSF) Leukine (sargramostim; GM-CSF) General Authorization Criteria for ALL Agents and Indications: Prescribed

More information

New Oncology Drugs: Nadeem Ikhlaque, M.D Subtitle Would Go Here

New Oncology Drugs: Nadeem Ikhlaque, M.D Subtitle Would Go Here New Oncology Drugs: A PowerPoint Brief Primer Cover Title Nadeem Ikhlaque, M.D 05.19.2017 Subtitle Would Go Here Learning Objectives List novel chemotherapies and the indications of these newer agents

More information

Reprogramming Tumor Associated Dendritic Cells for Immunotherapy

Reprogramming Tumor Associated Dendritic Cells for Immunotherapy Reprogramming Tumor Associated Dendritic Cells for Immunotherapy Edgar Engleman, M.D. Professor of Pathology and Medicine Stanford University Disclosures: Founder of Dendreon, a biotechnology company that

More information

Open clinical uro-oncology trials in Canada Eric Winquist, MD, George Rodrigues, MD

Open clinical uro-oncology trials in Canada Eric Winquist, MD, George Rodrigues, MD Open clinical uro-oncology trials in Canada Eric Winquist, MD, George Rodrigues, MD London Health Sciences Centre, London, Ontario, Canada BLADDER CANCER A MULTICENTRE, RANDOMIZED PLACEBO-CONTROLLED, DOUBLE-BLIND

More information

New Treatment Modalities and Clinical Trials for HRPC 계명의대 김천일

New Treatment Modalities and Clinical Trials for HRPC 계명의대 김천일 New Treatment Modalities and Clinical Trials for HRPC 계명의대 김천일 Castrate-Resistant Prostate Cancer (CRPC) Current standard therapy Androgen receptor (AR) in CRPC New systemic therapies Hormonal therapy

More information

HSHS St. Vincent Hospital Regional Cancer Center Adult Active Study List

HSHS St. Vincent Hospital Regional Cancer Center Adult Active Study List NHLBI-MDS ECOG-A NCT02775383 Blood Disorders-Other The National Myelodysplastic Syndromes (MDS) Study PNH Registry M07-001 DRUG CO NCT01374360 Blood Disorders-Other PNH Registry A071102 ALLIANCE NCT02152982

More information

Title Cancer Drug Phase Status

Title Cancer Drug Phase Status Clinical Trial Identifier Title Cancer Drug Phase Status NCT01164995 Study With Wee-1 Inhibitor MK-1775 and Carboplatin to Treat p53 Mutated Refractory and Resistant Ovarian Cancer Epithelial Ovarian Cancer

More information

New experimental targets for gastric cancer Andrés Cervantes

New experimental targets for gastric cancer Andrés Cervantes New experimental targets for gastric cancer Andrés Cervantes Professor of Medicine Outline Acquired capabilities of Cancer IGFR pathway PI3K-AKT-m-TOR pathway MET pathway FGFR pathway Check point inhibitors

More information

Index. neurosurgery.theclinics.com. Note: Page numbers of article titles are in boldface type.

Index. neurosurgery.theclinics.com. Note: Page numbers of article titles are in boldface type. Index Note: Page numbers of article titles are in boldface type. A A Complimentary Trial of an Immunotherapy Vaccine Against Tumor-specific EGFRvIII (ACTIVATE), 90 91 Active immunotherapy, 5 8, 96. See

More information

Etudes cliniques Service d Oncologie - Radiothérapie

Etudes cliniques Service d Oncologie - Radiothérapie Etudes cliniques Service d Oncologie - Radiothérapie Juillet 2017 SEIN NEO ADJUVANT Neo-RHEA : NEOadjuvant Biomarker ResearcH Study of Palbociclib in Estrogen Receptor Positive HER2 Negative Breast CAncer

More information

Amgen R&D Strategy. Sean Harper Executive Vice President, Research and Development

Amgen R&D Strategy. Sean Harper Executive Vice President, Research and Development Amgen R&D Strategy Sean Harper Executive Vice President, Research and Development Number of Drugs Per Billion US$ R&D Spending* Industry-Wide R&D Productivity Has Been Declining for Decades: A New Approach

More information

National Horizon Scanning Centre. Aflibercept (VEGF Trap) for advanced chemo-refractory epithelial ovarian cancer. December 2007

National Horizon Scanning Centre. Aflibercept (VEGF Trap) for advanced chemo-refractory epithelial ovarian cancer. December 2007 Aflibercept (VEGF Trap) for advanced chemo-refractory epithelial ovarian cancer December 2007 This technology summary is based on information available at the time of research and a limited literature

More information

2016 Updates in Oncology & Malignant Hematology Brendan Curley, DO

2016 Updates in Oncology & Malignant Hematology Brendan Curley, DO 2016 Updates in Oncology & Malignant Hematology Brendan Curley, DO Disclosures I received final support from ASCO Conquer Cancer foundation in two Merit Awards and one travel award I am on the speakers

More information

Summary of Research and Writing Activities in Oncology

Summary of Research and Writing Activities in Oncology Summary of Research and Writing Activities in Oncology Carole Alison Chrvala, PhD 919.545.2149 (Work) 919.951.5230 (Mobile) cchrvala@centurylink.net www.healthmattersmedwriting.com 1 Manuscripts, Posters,

More information

Studies proceeding under pre HRA-Approval system (NHS Permission)

Studies proceeding under pre HRA-Approval system (NHS Permission) 15/NW/0004 162679 Studies proceeding under pre HRA-roval system (NHS Permission) A MULTI-CENTRE RANDOMISED CLINICAL TRIAL OF BIOMARKER-DRIVEN MAINTENANCE TREATMENT FOR FIRST- LINE METASTATIC COLORECTAL

More information

Lecture 8: Antibodies & Antibody Conjugates - targeted cell killing agents

Lecture 8: Antibodies & Antibody Conjugates - targeted cell killing agents Lecture 8: Antibodies & Antibody Conjugates - targeted cell killing agents Monoclonal antibodies can be identified quickly by the mab at the end of their name. They are can be naked or conjugated depending

More information

National Cancer Drugs Fund List Ver4.4

National Cancer Drugs Fund List Ver4.4 National Cancer Drugs Fund List Ver4.4 Version Control Author(s) Owner David Thomson Chemotherapy Clinical Reference Group Version Control Version Date Revision summary Ver1.0 19 Mar 2014 Update following

More information

Corporate Medical Policy

Corporate Medical Policy Corporate Medical Policy File Name: Origination: Last CAP Review: Next CAP Review: Last Review: denosumab_prolia_xgeva 3/2011 9/2017 9/2018 9/2017 Description of Procedure or Service Receptor activator

More information

Avastin. Avastin (bevacizumab) Description

Avastin. Avastin (bevacizumab) Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.21.04 Subject: Avastin Page: 1 of 9 Last Review Date: September 20, 2018 Avastin Description Avastin

More information

Where Are Anti-Angiogenic Agents Positioned Within Cancer Care Guidelines?

Where Are Anti-Angiogenic Agents Positioned Within Cancer Care Guidelines? Introduction Additionally, other anti-angiogenic drugs, including sorafenib, sunitinib, axitinib, pazopanib, vandetanib, The development and subsequent use of drugs for treating cancer cabozantinib, and

More information

Investor Presentation

Investor Presentation Investor Presentation June 2017 Joe Turgeon President and Chief Operating Officer Safe Harbor Statement This presentation contains forward-looking statements regarding future events and the future performance

More information

Chemotherapy With or Without Targeted Drugs* in Metastatic Breast Cancer

Chemotherapy With or Without Targeted Drugs* in Metastatic Breast Cancer Diagnosis and Treatment of Patients with Primary and Metastatic Breast Cancer Chemotherapy With or Without Targeted Drugs* in Metastatic Breast Cancer * Substances without published evidence based on at

More information

For Health Professionals Who Care For Cancer Patients

For Health Professionals Who Care For Cancer Patients March 2018 Volume 21, No. 3 For Health Professionals Who Care For Cancer s Inside This Issue: Editor s Choice New Programs: Nivolumab for Squamous Cell Cancer of the Head and Neck, Ibrutinib for Mantle-Cell

More information

CHK1 Inhibitor. Prexasertib, LY MsOH H 2 O. Drug Discovery Platform: Cancer Cell Signaling

CHK1 Inhibitor. Prexasertib, LY MsOH H 2 O. Drug Discovery Platform: Cancer Cell Signaling CHK1 Inhibitor Prexasertib, LY2606368 MsOH H 2 O Derived from Garrett MD and Collins I 1 ; Thompson R and Eastman A. 2 Drug Discovery Platform: Cancer Cell Signaling A Phase 2 Study of LY2606368 in Patients

More information

Clinical Policy: Nivolumab (Opdivo) Reference Number: CP.PHAR.121 Effective Date: Last Review Date: Line of Business: Medicaid

Clinical Policy: Nivolumab (Opdivo) Reference Number: CP.PHAR.121 Effective Date: Last Review Date: Line of Business: Medicaid Clinical Policy: (Opdivo) Reference Number: CP.PHAR.121 Effective Date: 07.15 Last Review Date: 01.18 Line of Business: Medicaid Revision Log See Important Reminder at the end of this policy for important

More information

Cancer-Drug Associations: A Complex System

Cancer-Drug Associations: A Complex System Cancer-Drug Associations: A Complex System Ertugrul Dalkic 1,2,3, Xuewei Wang 1,4, Neil Wright 1,5, Christina Chan 1,2,3,4,6,7 * 1 Center for Systems Biology, Michigan State University, East Lansing, Michigan,

More information

Keytruda (pembrolizumab)

Keytruda (pembrolizumab) Keytruda (pembrolizumab) Line(s) of Business: HMO; PPO; QUEST Integration Akamai Advantage Original Effective Date: 10/01/2015 Current Effective Date: 07/24/2017TBD03/01/2018 POLICY A. INDICATIONS The

More information

Pharmacy Prior Authorization Colony Stimulating Factor (CSF)/Myeloid Growth Factor (MGF) Clinical Guideline

Pharmacy Prior Authorization Colony Stimulating Factor (CSF)/Myeloid Growth Factor (MGF) Clinical Guideline Neulasta (peg-filgrastim; G-CSF) Neupogen (filgrastim; G-CSF) Neulasta Onpro (peg-filgrastim; G-CSF) Leukine (sargramostim; GM-CSF) General Authorization Criteria for ALL Agents and Indications: Prescribed

More information

NEW DRUG FUNDING PROGRAM (NDFP) & EVIDENCE BUILDING PROGRAM (EBP) Approved Drugs and Eligibility Criteria

NEW DRUG FUNDING PROGRAM (NDFP) & EVIDENCE BUILDING PROGRAM (EBP) Approved Drugs and Eligibility Criteria NEW DRUG FUNDING PROGRAM (NDFP) & EVIDENCE BUILDING PROGRAM (EBP) Approved Drugs and Eligibility Criteria The information in this document is a summary of the funding criteria for the New Drug Funding

More information

MEDICAL NECESSITY GUIDELINE

MEDICAL NECESSITY GUIDELINE PAGE: 1 of 10 IMPORTANT REMINDER This Clinical Policy has been developed by appropriately experienced and licensed health care professionals based on a thorough review and consideration of generally accepted

More information

Clinical Trials OPEN to ENROLLMENT

Clinical Trials OPEN to ENROLLMENT CNS 2014 Second Quarter Clinical Trials OPEN to ENROLLMENT GAB 101 (CNS THERAPEUTICS INC): Safety of 3 mg/ml Gablofen (baclofen injection) Delivered by Intrathecal Administration Using the Synchromed II

More information

The Clinical Research E-News

The Clinical Research E-News Volume 3: ISSUE 2: January 26, 2011 The Clinical Research E-News Now Open: E2208, Randomized Phase II Study of Paclitaxel With or Without the Anti- IGF-IR mab Cixutumumab (IMC-A12) as Second Line Treatment

More information

Keytruda. Keytruda (pembrolizumab) Description

Keytruda. Keytruda (pembrolizumab) Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.21.50 Subject: Keytruda Page: 1 of 9 Last Review Date: September 20, 2018 Keytruda Description Keytruda

More information

Immune Checkpoint Inhibitors: The New Breakout Stars in Cancer Treatment

Immune Checkpoint Inhibitors: The New Breakout Stars in Cancer Treatment Immune Checkpoint Inhibitors: The New Breakout Stars in Cancer Treatment 1 Introductions Peter Langecker, MD, PhD Executive Medical Director, Global Oncology Clinipace Worldwide Mark Shapiro Vice President

More information

Corporate Medical Policy

Corporate Medical Policy Corporate Medical Policy Ado-Trastuzumab Emtansine (Trastuzumab-DM1) for Treatment of File Name: Origination: Last CAP Review: Next CAP Review: Last Review: ado_trastuzumab_emtansine_(trastuzumab-dm1)_for_treatment_of_her-2_positivemalignancies

More information

Clinical Policy: Ramucirumab (Cyramza) Reference Number: CP.PHAR.119

Clinical Policy: Ramucirumab (Cyramza) Reference Number: CP.PHAR.119 Clinical Policy: (Cyramza) Reference Number: CP.PHAR.119 Effective Date: 05/15 Last Review Date: 04/17 Coding Implications Revision Log See Important Reminder at the end of this policy for important regulatory

More information

Updates and best practices in the management of gastric cancer

Updates and best practices in the management of gastric cancer Updates and best practices in the management of gastric cancer Olatunji B. Alese, MD Gastrointestinal Oncology, Winship Cancer Institute of Emory University July 28, 2017 1 Incidence 3rd leading cause

More information

West of Scotland Cancer Network Guideline for Managing Chemotherapy Induced Nausea and Vomiting

West of Scotland Cancer Network Guideline for Managing Chemotherapy Induced Nausea and Vomiting West of Scotland Cancer Network Guideline for Managing Chemotherapy Induced Nausea and Vomiting Definitions Acute nausea and vomiting Delayed nausea and vomiting Anticipatory nausea and vomiting Initial

More information