FDA Makes Avastin Mistake For Breast Cancer Treatment

The Food and Drug Administration (FDA) released new information Friday about the approval of Roche Holding AG’s breast cancer drug Avastin. Two recent studies have provided new data indicating that the drug is not suitable for breast cancer patients.

Avastin was in early stage trials in 2008 when the FDA used the accelerated approval process to allow it to be a breast cancer treatment. A preliminary trial had initially shown Avastin provided 5.5 months of survival without an increase in cancer growth. Two additional trials were required for Avastin to meet with full FDA approval. The secondary two trials are calling the first Avastin results into question, with little to no improvement in patients and a range of unpleasant side effects.

Avastin is currently approved to treat several other types of cancer. Domestic and international Avastin sales reached roughly six billion dollars in the last fiscal year. It is estimated by financial analysts that losing the breast cancer approval would drop Avastin profits by one billion dollars.

The FDA’s committee for oncology drugs will meet Tuesday to discuss Avastin’s breast cancer approval. The committee will choose from several options, including removing the FDA’s approval for Avastin to treat breast cancer.