US FDA revokes Roche/Genentech Avastin license for metastatic breast cancer

After months of deliberations, the US Food and Drug Administration (FDA Commissioner is revoking the approval of Avastin (bevacizumab) for the treatment of metastatic breast cancer (mBC in the USA, the drug’s maker, Genentech, a subsidiary of Swiss pharma major Roche (ROG: SIX), announced on Friday. 

“This was a difficult decision,” said FDA Commissioner Margaret Hamburg, adding: “FDA recognizes how hard it is for patients and their families to cope with metastatic breast cancer and how great a need there is for more effective treatments. But patients must have confidence that drugs they take are both safe and effective for their intended use.”

This decision does not impact Avastin’s approved uses for other cancer types – such as colon, Lung, Kidney and brain cancer - in the USA or other countries, nor does it impact the approval of Avastin for mBC in more than 80 other countries. Also, the FDA's action does

Decision decried by FAMEDS