OBR Daily Commentary

forumImage

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).

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

Read Article arrow
Add Comment 1 Comment
forumImage

Some Pharmacy Benefit Manager Practices May Erode Patient Access to Cancer Care, ASCO Analysis Finds

(ASCO) Aug 30, 2018 - The American Society of Clinical Oncology (ASCO) warns that some of the practices used by pharmacy benefit manager (PBM) companies could hinder patient access to timely, high-quality cancer care. In a new position statement released today, ASCO describes a range of PBM practices that, while they may be intended to help control costs in cancer care, might compromise physicians’ ability to provide the right treatment at the right time for people with cancer; place cancer patients at risk of serious complications due to drug dispensing errors; or drive up out-of-pocket costs for patients. ASCO also recommends a series of actions to address PBM practices that interfere with the delivery of prescribed therapies. “Examples are emerging of PBM practices that may place patients at risk of life-threatening complications,” said ASCO President Monica M. Bertagnolli, MD, FACS, FASCO.

Winston Wong, PharmD (Posted: September 08, 2018)

quotesWhile reality demonstrates that these practices do create issues with regards to access and financial toxicity, it is a bit one-sided in that if the PBM is doing their job, there are patient support benefits. The key issue here is that some pharmacies are more efficient and better at providing these services than others. Patient follow-up, compliance and adherence monitoring are among the benefits. No question that there are major disconnects, and fixes are needed. Unfortunately, they are a result of our disjointed health care system.quotes

Read Article arrow
Add Comment 1 Comment
forumImage

Is Fairness in the Eye of the Beholder? Pfizer Citizen Petition Looking for Fair and Level Playing Field Between Biologics and Biosimilars

(FDA Law Blog) Aug 29, 2018 - An interesting Citizen Petition popped up earlier this week in which pharma giant Pfizer has requested FDA guidance on sponsor communications about biosimilar products.

Winston Wong, PharmD (Posted: September 08, 2018)

quotesWhile there may be some truth that there is a lack of confidence with biosimilar products, I believe that the confidence level is increasing, thus not the reason for the slow uptake in utilization. I believe that the true reason for the slow uptake is due to contracting and rebate levels increasing with the reference product so that there is little motivation for any stakeholder to switch to the biosimilar product. The power of the rebate is so woven into the selection process that unless the biosimilars start to represent more significant deeper discounts than they do today, uptake will continue to be slow.quotes

Read Article arrow
Add Comment 1 Comment

Meet the Editorial Board

Prostate Cancer
member photo
Tomasz M. Beer, MD, FACP

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

Community Oncology
member photo
Dean Gesme, MD

FACP FACPE FASCO President, Minnesota Oncology...

Breast Cancer
member photo
Debu Tripathy, MD

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

Lung Cancer
member photo
H. Jack West, MD

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

Gastrointestinal Cancers
member photo
Howard S. Hochster, MD

Distinguished Professor of Medicine, Rutgers Robert Woo...

Radiation Oncology
member photo
Howard Sandler, MD, MS, FASTRO

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

Community Oncology
member photo
Jeff Patton, M.D.

CEO Tennessee Oncology...

Precision Medicine Section Editor
member photo
Jennifer Levin Carter, MD, MPH

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

Financial Sector
member photo
Michael G. King Jr.

Managing Director and Senior Biotechnology Analyst...

Gastrointestinal Cancers
member photo
Richard Goldberg, MD

Director WVU Cancer Institute Director of Cancer Signa...

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

Professor and Director, Division of Hematology Oncology...

Health Policy
member photo
Ted Okon

Executive Director Community Oncology Alliance...

Community Oncology
member photo
Thomas Marsland, MD

Vice President Integrated Community Oncology Network ...

Community Oncology
member photo
William Harwin MD

Florida Cancer Specialists President and Managing Part...

Health Policy
member photo
William McGivney, PhD

National Health Policy Expert...

Payer
member photo
Winston Wong, PharmD

President, W-Squared Group...