OBR Daily Commentary

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Threshold Pharmaceuticals Initiates Clinical Trial Evaluating TH-302 in Combination With Sunitinib

(StreetInsider) June 29, 2011 - Threshold Pharmaceuticals, Inc., today announced the initiation of a Phase 1/2 dose escalation clinical trial of TH-302 in combination with sunitinib in patients with advanced renal cell carcinoma (RCC), gastrointestinal stromal tumor (GIST) and pancreatic neuroendocrine tumor (PNET).

Robert A. Figlin, MD., FACP (Posted: June 29, 2011)

quotesThe study proposed of TH-302 in combination with Sunitinib in renal cell carcinoma, GIST, and pancreatic neuroendocrine tumors will test the role of a novel agent targeting tumor hypoxia in a phase 1/2 study. Targeting tumor hypoxia in this study must also recognize that the biology of these tumors is distinctively different. Clear Cell RCCa is widely recognized as a disease with genetic control of tumor hypoxia through mechanisms that involve 3p and other chromosomal abnormalities. This is in contrast with GIST and neuroendocrine tumors, where tumor hypoxia is regulated through other mechanisms. It is hoped that in the development of this approach the investigators recognize the inherent biologic differences of the disease they will test in the phase 1 study.quotes

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New York Breast Cancer Charity Sued For Misusing Millions

(Fox News) June 28, 2011 - New York's attorney general filed a lawsuit Tuesday to shut down a phony breast cancer charity whose directors allegedly spent nearly all of the $9.1 million it raised over the past five years on exorbitant salaries and personal purchases.

William Harwin MD (Posted: June 29, 2011)

quotesThe reported allegations against this so called breast cancer charity Coalition Against Breast Cancer (CABC) is an outrage that should be dealt with sternly by New York's Attorney General. The bad publicity underlies the efforts of any number of organizations that raise money for cancer research and assistance for cancer patients. As an oncologist who has participated in Susan Komen, American Cancer Society, and on an annual basis the Pan Massachusetts Challenge bike event I find the alleged actions of the CABC unsettling and offensive to all of us that treat or have been personally impacted by a friend or relative with cancer.quotes

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F.D.A. Panel Rejects Use of Avastin for Breast Cancer

(NYT/Prescriptions blog) June 29, 2011 - An advisory committee to the Food and Drug Administration voted unanimously on Wednesday that the approval of Avastin as a treatment for breast cancer should be revoked, despite a two-day appeal hearing by Genentech, the drug’s manufacturer.

(Posted: June 29, 2011)

quotesAfter a two day hearing with presentations by many supporters of bevacizumab, the FDA came to the same conclusion they had many months ago, when they first recommended withdrawing approval for bevacizumab use in breast cancer. Bevacizumab combined with paclitaxel is still approved for use, until the FDA takes their final action expected this summer. There are several important issues that have been highlighted by the tremendous controversy surround approval of bevacizumab in the treatment of late stage breast cancer. First, endpoints required for approval seem to be variable depending on the agent added to standard therapy. For example, small benefits have led to approval of chemotherapy agents, despite additional toxicity. The FDA has commented on the lack of survival data, but in order to obtain survival benefit in first-line metastatic trials, we would either need very large studies that would be costly and difficult to complete, or we need to establish a very homogenous population to study. We have already observed significant variations in classifications of tumor biology, and recognize that many novel agents may be most effective in small breast cancer subsets. Our challenge is that we have not yet identified the subsets. The second issue is the extent of data required to confirm initial positive results, and what format confirmatory studies should take to avoid demonstrating clinical benefit not thought to be adequate for final drug approval. Lastly, this unfortunate ruling does provide a new direction and marching orders for breast oncology; we need to collect tissue in all patients enrolled in novel agent trials, and assign significant resources to identify subpopulations that benefit from specific targeted treatments. 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...

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...