Avastin as breast cancer treatment may get disapproved by the FDA


The FDA won't pull Avastin completely, but might say it can't be sold for certain purposes. Image from Wikimedia Commons.

A committee of the Food and Drug Administration has recommended that the approval for Avastin to be marketed as a breast cancer drug be pulled. A new round of clinical testing revealed the drug had little or no effect on breast cancers, after the first round of clinical trials for the drug showed positive results. The FDA has not ruled on whether the drug’s approval for marketing purposes is being canceled. Should the marketing approval be pulled by the FDA, the manufacturer of the drug, Roche, stands to lose a lot.

Avastin is the best selling cancer drug ever

Avastin is the trade name of Bevacizumab, a cancer medication. It’s called an angiogenesis inhibitor, which means it prohibits the growth of new blood vessels. It works by stopping a hormone called vascular endothelial growth factor, which stimulates blood vessel growth. According to the Los Angeles Times, the FDA fast tracked the drug for approval in 2008, conditioned on follow up studies to prove the drug really works. Roche and its subsidiary Genentech, which makes the drug, have failed to prove in a second round of trials that Avastin is definitely effective in eliminating or stopping breast cancer. The drug sells about $6 billion worth annually, and up to $1 billion of that is for breast cancer patients.

Roche feels side effects

The company that owns Genentech, Roche Holding Inc., dropped 4.1 percent in market shares after the FDA panel recommended pulling the approval to market the drug as a breast cancer treatment, according to Market Watch. The drop in share value comes on the heels of a series of lawsuits concerning Accutane, an anti-acne medication the company produces. Regardless of whether the drug won’t be used to treat breast cancer patients, it has proven very promising for treating other cancers.

Not the end of the drug

It takes a long time to develop effective medications, especially for diseases like cancer. There may well one day be a cure for cancer, but it will take a long time. If the FDA does pull its approval of Avastin being marketed for breast cancer treatments, it may lead to selling fewer pills, but that’s about it.

Further Reading

Los Angeles Times

Market Watch


Other recent posts by bryanh