OBR Daily Commentary

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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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Quickly Reporting Cancer Complications May Boost Survival

(Associated Press) June 4, 2017 - If you’re being treated for cancer, speak up about any side effects. A study that had patients use home computers to report symptoms like nausea and fatigue surprisingly improved survival — by almost half a year, longer than many new cancer drugs do.

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Howard S. Hochster, MD (Posted: June 05, 2017)

quotesIt's not the reporting but early intervention by caregivers to deal with symptoms of chemotherapy treatment. An amazing result! This results in fewer hospitalizations and improved survival. We need to up our game and proactively manage symptoms whether by PRO tools or direct contact. Everyone benefits. 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...

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...