OBR Daily Commentary

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UK's Body NICE Blocks Novartis's Kidney Cancer Drug Afinitor

(SmartMoney/Dow Jones Newswires) Nov 25, 2010 - The U.K. health cost body Friday said it refuses to back Novartis AG's kidney cancer drug Afinitor as a second line treatment due to lingering cost and efficiency concerns even as the Swiss pharma giant, which said it will appeal the verdict, has cut the price for the drug.

Robert A. Figlin, MD., FACP (Posted: November 29, 2010)

quotesThis decision is just another example that highlights the challenges in drug development. In this case we have a drug Afinitor that has demonstrated clinical efficacy following prior VEGFr TKI therapy in metastatic renal cell carcinoma and is approved for use in the United States and the EU. It is not that the data is being questioned as much as the value added to this patient population of the treatment effects. The medical oncology community (ie: physicians, industry, patient advocate groups, health care providers) will consistently be asked to not only prove a drugs effectiveness using standard metrics of benefit (ie: PFS, OS )but also demonstrate why a health care dollar should be used for this intervention vs another. This is a challenging time for drug development as the clinical trials often ask questions that answer only part of the effectiveness question for a particular therapy. It should be the oncology community at large including all interested parties that set the agenda for what constitutes "effectiveness" when the health care dollar is not unlimited. This announcement today will be just one of the many future similar challenges we all face in caring for our patients.quotes

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UK's NICE Recommends Roche's Herceptin For Stomach Cancer

(SmartMoney/Dow Jones Newswires) Nov 23, 2010 - The U.K.'s National Institute for Health and Clinical Excellence Wednesday said it recommended Roche Holding AG's Herceptin oncology drug be made routinely available on the publicly funded National Health Service to certain patients with metastatic gastric cancer.

Howard S. Hochster, MD (Posted: November 24, 2010)

quotesFor once NICE leads the pack on approval of a new cancer drug. This seems fairly revolutionary for the nation which never believed in paclitaxel for ovarian cancer and the agency that approved oxaliplatin (for reimbursement) only in potentially resectable metastatic colorectal cancer to the liver. Of interest, they are focused more on the high HER-2 expressors, which may be IHC 3+ or FISH high copy number. We are not aware of the analysis presented to NICE and what percent of patients fall into this group. In any case, in the US, few patients fall into this group, but hopefully the FDA will follow suit shortly. ASCO will need to develop the specific testing guidelines (IHC, FISH or both) to match the approval.quotes

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Cancer Drug Shortage Arrives

(Anchorage Daily News) Nov 20, 2010 - Cancer doctors say a national shortage of a chemotherapy drug has hit Anchorage, is already disrupting treatment for local patients, and could affect dozens more if it continues.

(Posted: November 22, 2010)

quotesThe ongoing shortage of commonly used but older and more cost effective chemotherapy agents represents a major issue for Hem/Onc physicians and their patients. This is particularly true when the illness being treated is a curable malignancy such as Hodgkin or non-Hodgkin lymphoma. The recent shortage of doxorubicin (Adriamycin) is the most difficult example yet of this recent phenomenon. There are no proven equivalent substitutes for doxorubicin for these highly curable patients. It is forcing many oncologists to ration or substitute less proven agents for these patients. The system needs to be modified so that these older agents can still be competitive for companies to make despite being cost effective. Alternatively, a standardized manufacturer that is underwritten by the government must assure there is an adequate supply for these life saving drugs available for our patients. quotes

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Meet the Editorial Board

Prostate Cancer
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Tomasz M. Beer, MD, FACP

Professor of Medicine, Division of Hematology/Medical O...

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

Distinguished Professor of Medicine, Rutgers Robert Woo...

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...

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Jennifer Levin Carter, MD, MPH

Chief Medical Officer and Founder, N-of-One...

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Michael G. King Jr.

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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...

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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...

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Winston Wong, PharmD

President, W-Squared Group...