FDA Panel Votes to Rescind Approval of Cancer Drug
The Associated Press has reported on the 12-1 results of a vote in favor of rescinding the Food and Drug Administration’s (FDA) approval of a drug’s use in treating breast cancer. The vote, conducted by a panel of FDA cancer experts, was in regard to the Roche Pharmaceutical drug Avastin. According to the article, follow-up studies on Avastin did not demonstrate benefits for patients.
The panel’s vote was reportedly limited to Avastin’s use only in breast cancer. The panel’s advice is not binding on the FDA, however, it is usually followed. Other reportedly approved uses for Avastin include treatment for colon, lung, kidney and brain cancer.
In 2008, the FDA approved Avastin as a breast cancer treatment reportedly based on a trial that it extended the amount of time, by over five months, until the disease worsened.
The conditional approval reportedly required follow-up studies. Roche, according to the AP, submitted two follow-up studies that did not have the same results. In these studies, Avastin did not delay the cancer’s progression as it did in the first study and did not demonstrate a significant improvement in lifespan.
Roche reportedly asserted to the panel that Avastin improved the quality of life in patients, however, the panel was not convinced.
