FDA Approval for Avastin Rescinded

The Food and Drug Administration (FDA) announced that it is rescinding its 2008 approval of the drug, Avastin, for the treatment of metastatic breast cancer. Federal health officials voted twelve to one to recommend the discontinuation of the use of Avastin to treat breast cancer. Genentech, the manufacturer of the drug and a subsidiary of Roche pharmaceutical company, has fifteen days to appeal the recommendation.

The FDA put Avastin on the fast-track for approval in 2008. They conditionally approved the drug based on initial clinical trials that showed the drug could prevent tumor growth for a longer span of time which provided the patient with a better quality of life. Fast-track approval requires that additional clinical trials substantiate the initial findings. However, each of the three following studies did not corroborate these findings. Furthermore, they indicated that the drug did not decrease tumor growth. Additionally, Avastin was found to cause life-threatening side effects not caused by other, more effective breast cancer drugs. These side effects include heart attacks, heart or kidney failure, nose bleeds, and bleeding of the intestine and stomach. The subsequent studies, combined with the severe adverse side effects have caused the FDA to rescind its previous approval of Avastin for breast cancer treatment.

Some doctors are disappointed in the FDA’s recommendation. They state there is definitely a population of women that the drug treats effectively, but they need more time to identify the specific tumors or patient population the drug will work on effectively. The FDA also conceded that if approval for Avastin is actually rescinded, it could be reinstated for specific groups of patients who it would benefit.

It is also worth mentioning that the FDA made their recommendation on the same day that the European Union’s Committee for Medicinal Products for Human Use (CHMP) praised the merits of the use of Avastin for breast cancer treatment when used in conjunction with another cancer drug called Paclitaxel. Utilizing a combination of medications in chemotherapy is common. It will be interesting to see if the data the FDA used to make their recommendation mirrors the data CHMP used to sing Avastin’s praises. If CHMP’s data proves that Avastin is effective for the treatment of metastatic breast cancer, Genentech could utilize CHMP’s data to win their appeal of the FDA’s decision.

Breast cancer patients currently taking the drug are not expected to experience any immediate affects from the FDA’s recommendation such as a limited supply. Doctors can still use their discretion to continue prescribing Avastin for breast cancer as an “off label” drug, like they do with many other drugs, since Avastin is currently approved for treating brain, kidney, lung, and colon cancers. However, many insurance companies will not cover “off label” drugs. At a cost of $8,000 a month, many patients may find the cost prohibitive.

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