OBR Daily Commentary

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FDA Approves Amgen And Allergan's MVASI™ (bevacizumab-awwb) For The Treatment Of Five Types Of Cancer

(MarketWatch) Sept 14, 2017 - Amgen today announced that the U.S. Food and Drug Administration (FDA) has approved MVASI™ (bevacizumab-awwb) for all eligible indications of the reference product, Avastin [®] (bevacizumab).

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Howard S. Hochster, MD (Posted: September 15, 2017)

quotesFirst approval for a biosimilar in solid tumor usage! This should help bring down the cost of bev by about 1/3. Other bev biosimilars to follow. There is no approval for interchangeability with originator bev, and this must be prescribed specifically using the suffix. But this should be regarded as a step forward for patients and for control of costs. Ironically, Amgen took Novartis to the SCOTUS to delay their roll out of biosimilar filgrastim. Speak to your pharmacy committees!quotes

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Supreme Court Speeds Copycat Biologic Drugs to Market

(Reuters) June 12, 2017 - The U.S. Supreme Court on Monday cut the time it will take for copycat versions of biologic drugs to get to the market in a pivotal ruling about an expensive class of medicines that can yield billions of dollars in sales for drug companies.

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Howard S. Hochster, MD (Posted: June 13, 2017)

quotesA victory for consumers and cost control. SCOTUS overcame lower court considerations and parsed the BPCIA wording to mean that the biosimilar manufacturer does not need to wait 180 days after FDA approval. They can notify the originator company before actual approval. This cuts out the extra 6 month exclusivity Amgen was seeking. Looking forward to more biosimilar molecules on the market next year. quotes

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Cancer Drug Proves to Be Effective Against Multiple Tumors

(New York Times) June 8, 2017 - The 86 cancer patients were a disparate group, with tumors of the pancreas, prostate, uterus or bone. One woman had a cancer so rare there were no tested treatments. She was told to get her affairs in order.

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Howard S. Hochster, MD (Posted: June 09, 2017)

quotesAnother article by Gina Kolata where she dramatizes the situation and misses the key message. This article focuses on the fact that anti-PD1 did not work for most CRC (specifically citing the "failed" drug nivolumab) and how pembro turned it around for MSI-high patients. She brings up the cost and this has become the focus of many tweets on the article. She misses the most newsworthy fact that this is a groundbreaking approval for the FDA, moving from a histologic indication to a molecular indication. As practicing oncologists, we must stand and applaud the FDA for stepping outside their comfort zone on this one and recognizing the realities of treating such patients. MSI status now becomes a therapeutic handle rather than a genetic disease-related effect. Gina Kolata did, however, do a fine job recognizing the key contribution of Dr Luis Diaz here. quotes

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Meet the Editorial Board

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

Associate Cancer Center Director, Yale Cancer Center P...

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...