OBR Daily Commentary

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DNA Mutations Shed in Blood Predicts Response to Immunotherapy in Patients with Cancer

(UC San Diego Health) Oct 1, 2017 - In a first-of-its-kind study, University of California San Diego School of Medicine researchers report that a blood sample, or liquid biopsy, can reveal which patients will respond to checkpoint inhibitor-based immunotherapies.

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Howard S. Hochster, MD (Posted: October 02, 2017)

quotesThis interesting study from Kurzrock and colleagues looks at circulating tumor DNA (ctDNA) to determine who may benefit from immunotherapy. The study included 69 patients with various diagnoses. With more than 3 mutations detected on the 70-gene panel the response rate was 45% in this group compared with 15% for those with 3 or fewer mutations. Presumably this is closely linked with the calculated "tumor mutation burdern" score. This is a good step in the effort to define the utility of ctDNA which is determined on a blood draw and can be done serially. The title refers to this as "liquid biopsy" though in the old days it was just "phlebotomy" for a blood analysis. quotes

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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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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...