OBR Daily Commentary

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U.S. Supreme Court Agrees To Hear Dispute Over Biologic Drug Sales

(Reuters) Jan 13, 2017 - The U.S. Supreme Court on Friday agreed to hear a dispute over whether companies that make copycat versions of biologic drugs must wait six months after winning federal approval to begin selling them.

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Howard S. Hochster, MD (Posted: January 17, 2017)

quotesThe Supreme Court ruling is important in the coming era of biosimilars. This is an area where the Supremes should be educated on the difference in the approval process for biosimilars versus generics. In the case of biosimilars, the sponsor of the new agent is not only required to support extensive manufacturing data, mechanistic data and composition within tolerable manufacturing bands compared to the originator compound, but they must conduct expensive and time-consuming clinical trials to show clinical equivalence to the originator compound. Biosimilar compounds are named individually with a suffix to the international name so they can be individually distinguished. The extra 180 waiting day for generics should not be extended to biosimilars. They are actual new drugs requiring extensive testing and individual naming.quotes

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Advaxis Announces GOG-0265 12-month Overall Survival Rate of 37.5% in Stage 2

(Advaxis) Oct 24, 2016 - Advaxis, Inc., a clinical stage biotechnology company developing cancer immunotherapies, today announced topline results from the early closure of stage 2 of the Phase 2 GOG-0265 trial, conducted by the Gynecologic Oncology Group (GOG, now part of NRG Oncology) and supported by the Cancer Therapy Evaluation Program (CTEP) of the National Cancer Institute (NCI).

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Howard S. Hochster, MD (Posted: October 25, 2016)

quotesThis is an important proof of concept. The engineered listeria bacterium is both attenuated and loaded with hpv genes. When taken up in macrophages this novel biologic acts like a super vaccine. The 1-year survival of these refractory Cervix cancer patients is better than expected. We hope to see even better activity in metastatic anal cancer, where no good therapies exist. quotes

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Chemotherapy Combination With Capecitabine Extends Survival After Pancreatic Cancer Surgery

(ASCO Annual Meeting) June 3, 2016 - A European phase III trial, one of the largest ever conducted in pancreatic cancer, showed that adding the oral drug capecitabine chemotherapy to gemcitabine prolongs survival without increased toxicity.

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Howard S. Hochster, MD (Posted: June 04, 2016)

quotesWe have known for a while that combinations are in fact more active in advanced pancreatic cancer. This is the first large study showing the benefit of adding a second anti metabolite on long term outcome. With HR for survival of 0.82, statistical significance was achieved and 18% more patients are likely to be cured with the addition of capecitabine. Most impressive is the 5 year survival of 29 vs 16%. While toxicity is somewhat higher for the combination arm, this seems like a good trade-off. Gem-cape is likely to be the new standard for adjuvant therapy until we see the results of the APACT trial with nab-paclitaxel. 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

Professor and Chair, Department of Radiation Oncology...

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...

Health Policy
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Joseph Bailes, MD

National Health Policy Expert...

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

Professor and Physician-in-Chief of the Ohios State Uni...

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

Professor and Director, Division of Hematology Oncology...

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...