Avastin Approval for Treatment of Breast Cancer Revoked

Balancing the needs of so-called “super responders” with the ethics of efficacy and serious side effects can be a delicate balance at best.  But the FDA, after hearing an appeal by Genentech (owned by Roche), manufacturer of the drug Avastin (bevacizumab), stood by its decision to pull the plug on the drug’s indicator for breast cancer.

Emotions ran high early in the summer when the FDA initially pulled the indication in the treatment of breast cancer.  Women who seem to have responded remarkably well to bevacizumab – super responders – challenged the FDA contention that Avastin is ineffective against metastic breast cancer when combined with the anti-cancer drug paclitaxel.

The FDA decision also ran counter to the recommendations of the breast cancer guideline committee of the National Comprehensive Cancer Network (NCCN) which voted 24-0 with one abstention in June to stand by its existing recommendation that “bevacizumab in combination with paclitaxel is an appropriate therapeutic option for metastatic breast cancer.” Ten of the panel’s 33 members have relationships with Genentech/Roche.

The FDA had originally fast tracked the drug when progression-free survival benefits were observed with bevacizumab in an early study. However, the FDA concluded that follow up studies failed to confirm the findings. The drug has also been shown to have potentially serious side effects like severe high blood pressure and hemorrhaging.

The Genentech drug retains its indications for colon, lung, kidney, and brain cancer and will remain on the market allowing doctors to prescribe it off-label for breast cancer.  However patients will most likely have to foot the $8,000 bill per month themselves.

According to a company spokesperson, a new phase III study of bevacizumab in combination with paclitaxel in previously untreated metastatic breast cancer will be started. Genetech hopes to use specific biomarkers to pinpoint which patients are most likely to benefit from the drug.

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