FDA Denies Avastin Decision Based on Cost

Responding 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.

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