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Posted by on Jan 7, 2011 in FDA, Oncology, Pharma

FDA Denies Avastin Decision Based on Cost

FDA Denies Avastin Decision Based on Cost

Roche.jpgResponding to a charge by some House Republicans that the FDA considered cost in its decision to pull Avastin’s indication for breast cancer, the agency’s oncology director says that drug price was not considered. Dr. Richard Pazdur responded, according to today’s WSJ

We made the decision because the drug has a marginal effect on tumor growth in breast cancer and in light of Avastin’s severe side effects, the risks outweigh the limited benefit.

Pazdur cited “issues” and “problems” with a pivotal study, E2100, which showed that Avastin (with paclitaxel) delays the growth of advanced breast cancer for 5 months. Not surprisingly, drugmaker Genentech, a subsidiary of Roche, rejects the FDA’s view of the controversial study and its results. But follow-up studies failed to confirm the favorable results of E2100, reports the WSJ. Some insurance companies, acting independently of the FDA, have already denied coverage for the use of Avastin in metastatic breast cancer.

For the full story go here. For background, go here.

bmartin (1127 Posts)

A native East Tennessean, Barbara Martin is a formerly practicing, board-certified neurologist who received her BS (psychology, summa cum laude) and MD from Duke University before completing her postgraduate training (internship, residency, fellowship) at the Hospital of the University of Pennsylvania in Philadelphia. She has worked in academia, private practice, medical publishing, drug market research, and continuing medical education (CME). For the last 3 years, she has worked in a freelance capacity as a medical writer, analyst, and consultant. Follow Dr. Barbara Martin on and Twitter.