OBR Daily Commentary

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FDA Approves Olaparib For HRR Gene-Mutated Metastatic Castration-Resistant Prostate Cancer

(FDA.gov) May 20, 2020 - On May 19, 2020, the Food and Drug Administration approved olaparib (LYNPARZA, AstraZeneca Pharmaceuticals, LP) for adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC), who have progressed following prior treatment with enzalutamide or abiraterone. Today, the FDA also approved FoundationOne CDx (Foundation Medicine, Inc.) for selection of patients with mCRPC carrying HRR gene alterations and BRACAnalysis CDx test (Myriad Genetic Laboratories, Inc.) for selection of patients with mCRPC carrying germline BRCA1/2 alterations as companion diagnostic devices for treatment with olaparib.

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Tomasz M. Beer, MD, FACP (Posted: May 21, 2020)

quotesPAPR inhibitor approval means that we will need to genotype all advanced prostate cancer patients. With about 20% of patients potentially benefiting, the era of precision oncology is upon us. quotes

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ERLEADA® (apalutamide) Significantly Improved Overall Survival in Patients with Non-Metastatic Castration-Resistant Prostate Cancer

(Janssen) May 13, 2020 - The Janssen Pharmaceutical Companies of Johnson & Johnson announced today results from the final analysis of the pivotal Phase 3 SPARTAN study demonstrating ERLEADA® (apalutamide) in combination with androgen deprivation therapy (ADT) significantly improved overall survival (OS), compared to ADT alone, in patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who were at high risk of developing metastases.

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Tomasz M. Beer, MD, FACP (Posted: May 14, 2020)

quotesWe expect to see overall survival results from several agents in non-metastatic castration resistant prostate cancer. I will be discussing these presentations at the ASCO meeting in a presentation entitled "Advanced Prostate Cancer: Putting Survival Into Perspective". I look forward to offering my commentary at the meeting. quotes

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NUBEQA® (darolutamide) Plus Androgen Deprivation Therapy Achieved the Secondary Endpoint of Overall Survival (OS) in Men with Non-Metastatic Castration-Resistant Prostate Cancer

(Bayer) Jan 30, 2020 - Results from the preplanned final overall survival analysis of the Phase III ARAMIS (Androgen Receptor inhibiting Agent for MetastatIc-free Survival) trial that investigated NUBEQA® (darolutamide) in men with non-metastatic castration-resistant prostate cancer (nmCRPC) show a significant improvement in overall survival (OS) in patients receiving NUBEQA plus androgen deprivation therapy (ADT) compared to placebo plus ADT. Results of ARAMIS previously published show a statistically significant improvement in the primary efficacy endpoint of metastasis-free survival (MFS) of darolutamide plus ADT compared to placebo plus ADT; however OS data were not yet mature at the time of the MFS analysis. Detailed data on the updated OS and other additional endpoints as well as an update on longer term safety will be presented at an upcoming scientific meeting.

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Tomasz M. Beer, MD, FACP (Posted: January 30, 2020)

quotesThe magnitude of the OS benefit will be of significant interest. Three agents have been approved in this setting based on metastases-free survival results with overall survival not mature. This is the first report that overall survival is improved. This would be expected given that this class of agents improved OS in metastatic disease, but it is reassuring that such results are being confirmed in the non-metastatic population. However, the available press release provides little details and the actual results are eagerly awaited.quotes

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Meet the Editorial Board

Prostate Cancer
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Tomasz M. Beer, MD, FACP

Professor of Medicine, Division of Hematology/Medical O...

Community Oncology
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Dean Gesme, MD

FACP FACPE FASCO President, Minnesota Oncology...

Breast Cancer
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Debu Tripathy, MD

Professor and Chair, Department of Breast Medical Oncol...

Lung Cancer
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H. Jack West, MD

Associate Clinical Professor, Medical Oncology Executi...

Gastrointestinal Cancers
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Howard S. Hochster, MD

Distinguished Professor of Medicine, Rutgers Robert Woo...

Radiation Oncology
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Howard Sandler, MD, MS, FASTRO

Ronald H. Bloom Chair in Cancer Therapeutics
Pr...

Editor-In-Chief
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Robert A. Figlin, MD., FACP

Professor and Director, Division of Hematology Oncology...

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Stephen M. Schleicher, M.D., MBA

Community Oncology, Medical Oncologist, OneOncology...

Health Policy
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Ted Okon

Executive Director Community Oncology Alliance...

Community Oncology
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Thomas Marsland, MD

Vice President Integrated Community Oncology Network ...

Health Policy
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William McGivney, PhD

National Health Policy Expert...