OBR Daily Commentary

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Glaxo's Kidney-Cancer Drug Votrient Wins U.K. Backing With Price Agreement

(Bloomberg) Dec 23, 2010 - GlaxoSmithKline Plc, Europe’s second-largest drugmaker by sales, won the backing of the U.K. National Institute for Health and Clinical Excellence for the Votrient kidney-cancer pill after agreeing to lower the price.

Robert A. Figlin, MD., FACP (Posted: January 03, 2011)

quotesThe approval by the UK to offer Votrient to patients with advanced renal cell carcinoma now allows patients in the UK the option of another antiangiogenic drug targeting the VEGF receptors. This agent has been demonstrated to improve progression free survival when compared to a placebo, and has an acceptable toxicity profile. This announcement also allows for the integration of a comparative effectiveness trial comparing Sutent with Votrient in a completed large scale trial to be reported in the near future. This result is but further evidence that the pharmaceutical industry will be required to demonstrate more than just clinical effectiveness when considering drug development, especially in diseases like renal cell carcinoma where there has been the approval of 6 new agents in less than 5 years. quotes

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Gene Mutation Suggests New Treatment Target for Specific Lymphoma

(U.S. News & World Report) Dec 22, 2010 - Researchers have identified a gene mutation that may offer a target for new treatments for a type of lymphoma. The team found that a mutation of the MYD88 gene is one of the most frequent genetic abnormalities in patients with this cancer, known as large B cell lymphoma.

(Posted: December 24, 2010)

quotesAs lymphoma research advances, several very important discoveries have identified important proteins or pathways that appear to be more frequent in specific types or subtypes of lymphoma. The MYD88 genetic mutation is a new discovery in the activated B-cell type (ABC) of diffuse large B-cell lymphoma (DLBCL). This subtype is more difficult to treat than other subtypes of DLBCL and identifying potential target areas for novel therapies is an important area of research. The next step after identifying the pathways, proteins, or genetic abnormalities, is to test novel agents that target the specific pathway for treatment in patients with that subtype of lymphoma. Several different clinical trials are using this model now and it is hoped that additional information will be obtained over the next several years to validate this type of target identification. If successful, this targeted therapy could help us to use specific therapies in patients who are predicted to respond to the therapy and to decrease the use of possibly toxic and expensive therapies in those that are not predicted to respond. quotes

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Roche's Avastin Rejected By UK Cost Body For Bowel Cancer

(FOX Business/Dow Jones Newswires) Dec 14, 2010 - The U.K.'s health-care cost regulator Wednesday said it won't recommend Roche Holding AG's Avastin to treat patients with bowel cancer, due to the medicine's high cost and limited efficiency.

Howard S. Hochster, MD (Posted: December 16, 2010)

quotesWhat criteria should we use to approve the use of new drugs and how do we decide if they are worth the cost? Who should make these decisions? In the US, the FDA approves a drug and CMS is obliged to pay for the on-label use. Some off-label indications may be covered with additional literature. In England, the NICE organization judges cost-effectiveness. I recently applauded their early approval of trastuzumab for some cases of gastric cancer. Now we see NICE may not be so nice in refusing to pay for the drug in metastatic colon cancer. Of course, this decision only applies to NHS insurance, and the drug is still available in the UK for private payors and those with other insurance. Why this decision? NICE based their decision on the unfortunate results of the Roche 966 trial, one of the largest metastatic CRC trials ever, rather than the pivotal Genentech 2107 trial using IFL as the chemotherapy regimen. The primary endpoint of the 966 trial was to show non-inferiority of CapeOx compared with FOLFOX, and the regimens were indeed equivalent. However in an amendment, 1400 patients were also re-randomized to treatment with or without bevacizumab. In both arms patients treatment was stopped at 6 months, with the development of oxaliplatin neurotoxicity, in the great majority of patients. In this case, the benefit of bevacizumab could not be adequately demonstrated. A second statistical analysis censoring patients 30 days after going off study (rather than using the actual date of progression even for those who stopped treatment) showed much greater effect for bevacizumab, consistent with the hypothesis that the drug was effective as long as it was given. So, large "well-conducted" trials are not always performed as expected; clinical research often has unanticipated pitfalls. Demonstrating the additive benefit of any biologic in combination with an active chemotherapy regimen is a difficult task, as also seen for bevacizumab in breast cancer, and remains a challenge. Cost-effectiveness is in the eye of the beholder. A bureaucratic view of benefit is certainly different from those on treatment for metastatic cancer. Borderline trial results, even in flawed trials, will be used to keep a lid on costs of cancer treatment. 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...