OBR Daily Commentary

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Pfizer Drug Wins FDA Panel’s Backing for Pancreatic Cancer

(Bloomberg) Apr 12, 2011 - Pfizer Inc. won a U.S. panel’s backing to expand marketing of a cancer drug for patients with the rare type of pancreatic tumor diagnosed in Apple Inc.’s Steve Jobs in 2004.

Robert A. Figlin, MD., FACP (Posted: April 12, 2011)

quotesThe recommendation by ODAC today to approve both Sunitinib and Everolimus for the treatment of pancreatic neuroendocrine tumors (NET) is yet another example of how we continue to understand the biology of cancers with drugs that have been approved for other indications. Both Sunitinib and Everolimus received their first approvals in the cancer space for the treatment of metastatic renal cell carcinoma in the first- and second-line respectively. Although not a common disease, there have been few new options for treatment for pancreatic NET until the results of recent trials and the presentation to the FDA that may result in the availability of Sunitinib and Everolimus. They inhibit different pathways and it will be important to understand in what sequence and which agent offers the better opportunity for benefit. It also offers the opportunity for a study of the drugs' comparative effectiveness to help clinicians know what to expect from each agent, and in what sequence. quotes

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Joint Statement of Undisputed Facts and Select Issues in Dispute of the FDA Center for Drug Evaluation and Research and Genentech, Inc.

(Genentech) Apr 7, 2011 - On April 7, 2011, Genentech and the FDA's Center for Drug Evaluation and Research (CDER) submitted a joint statement of facts not in dispute and issues that are disputed.

William Harwin MD (Posted: April 08, 2011)

quotesFascinating read. I don't know that it was well known how lopsided all the ODAC votes were against Avastin as far as the risk-benefit ratio. Avastin's use in breast cancer has dropped considerably and Genentech has an uphill climb ahead. quotes

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Off Label

(ASCO Connection Blog) Apr 6, 2011 - What is old, is new again. Off-label use of oncology drugs is common; and has long been the focus of controversy.

Thomas Marsland, MD (Posted: April 08, 2011)

quotesWith more grey hairs than my friend and colleague, Dr. Cox, I too remember the "good old days" when off-label usage was much simpler. There is no question that today life is much more complex due to more rules and regulations and most importantly cost. In the past once a drug was approved it was relatively easy to use off-label but indeed there were a lot fewer drugs and the cost of these agents was significantly less. Even in those days however, rarely was a drug used without some evidence to support its use. I remember sitting in on multiple ASCO presentations of definitive, practice-changing paper only to find out that many times the treatment was something I had routinely been doing based on early Phase II data. With the rapidly rising cost of so many of the newer drugs, I do support strong criteria for off-label usage, but this really needs to be clearly defined so that the payer community can more quickly cover off-label indications with less hassle to the practices. The paper cited by Dr. Cox does have some flaws since in the review claims data was used and it can often be difficult to get accurate clinical information from claims data so that their rates of off-label usage could have been overestimated. 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...