OBR Daily Commentary

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Dismissing Reduced Abiraterone Dose Is 'Absolutely Wrong'

(Medscape Medical News) Sept 17, 2018 - A debate has intensified about cutting the dose — and hence the cost — of the oral prostate cancer drug abiraterone acetate (Zytiga, Janssen) by taking it with food.

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Tomasz M. Beer, MD, FACP (Posted: September 18, 2018)

quotesWhile there is room for a range of views, this is a situation where there must be room for clinical skill and judgment. Skilled clinical assessment and monitoring of cancer status, carried out by an expert oncologist would very likely capture the benefits of abiraterone even if dosed in an alternative fashion. Oncologists do not practice strictly "on label" in any disease. They integrate best available evidence and apply it to each individual patient's unique circumstance. There is no question that the evidence is strongest for conventional food-free dosing, but there is now sufficient evidence to have a through discussion with individual patients about the option of alternative dosing when the economic consequences of not doing so may deny the patient access to the drug altogether. quotes

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Progenics Pharmaceuticals Reports Top Line Phase 3 Data for Prostate Cancer Imaging Agent 1404

(NASDAQ) Sept 12, 2018 - Meets co-primary endpoint of specificity; 1404 successfully identifies patients without clinically significant prostate cancer; co-primary endpoint of sensitivity to identify patients with clinically significant disease not met.

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Tomasz M. Beer, MD, FACP (Posted: September 13, 2018)

quotesLow sensitivity seen in this trial is a bit of a disappointment. We will need to learn more about this result as the data are fully analyzed, presented, and published. Low sensitivity means that a negative result is not as reassuring for patients as one would have hoped.quotes

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Endocyte Announces FDA Acceptance of Radiographic Progression Free Survival (rPFS) as an Alternative Primary Endpoint of the VISION Trial in Addition to Overall Survival (OS)

(Morningstar) Sept 10, 2018 - Endocyte, Inc., a biopharmaceutical company developing targeted therapeutics for personalized cancer treatment, today announced that following a meeting with the U.S. Food and Drug Administration (FDA), it was determined that rPFS is an appropriate efficacy endpoint in the ongoing phase 3 VISION trial to support the submission of a New Drug Application (NDA) for full FDA approval of 177Lu-PSMA-617 for the treatment of metastatic castration-resistant prostate cancer (mCRPC).

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Tomasz M. Beer, MD, FACP (Posted: September 10, 2018)

quotesIntermediate endpoints can speed the delivery of impactful drugs to patients and in prostate cancer, where we now have multiple lines of therapy, it is important that we consider intermediate endpoints because overall survival can be impacted by subsequent therapies and take a long time to measure. But the progression-free survival advantage has to be clear and compelling in quality and magnitude to serve as a robust measure of patient benefit.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

Medical Director, Thoracic Oncology Program, Swedish Ca...

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...

Community Oncology
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Jeff Patton, M.D.

CEO Tennessee Oncology...

Precision Medicine Section Editor
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Jennifer Levin Carter, MD, MPH

Chief Medical Officer and Founder, N-of-One...

Financial Sector
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Michael G. King Jr.

Managing Director and Senior Biotechnology Analyst...

Gastrointestinal Cancers
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Richard Goldberg, MD

Director WVU Cancer Institute Director of Cancer Signa...

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

Professor and Director, Division of Hematology Oncology...

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 ...

Community Oncology
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William Harwin MD

Florida Cancer Specialists President and Managing Part...

Health Policy
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William McGivney, PhD

National Health Policy Expert...

Payer
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Winston Wong, PharmD

President, W-Squared Group...