| ■ Drug's Breast Cancer Promise Seems to Fade: Report | 2010.07.16 |
| U.S. regulators could rescind approval of the cancer drug Avastin for the treatment of breast cancer, based on follow-up studies reported Friday that failed to show the medication shrank tumors or extended lives, according to published reports. The Food and Drug Administration on Tuesday will ask a panel of outside experts to review the evidence on the Roche drug, the Associated Press said. It's possible the FDA will withdraw approval of Avastin as a breast cancer treatment. The drug is also approved for lung, colon, brain and kidney cancer. Avastin received conditional FDA approval in 2008 based on preliminary evidence that it shrank breast cancer tumors. Continued approval would depend on subsequent studies showing a survival benefit, the agency said. But two follow-up studies recently submitted by Roche failed to show that Avastin prolonged lives significantly longer than chemotherapy alone, the AP said. And the tumor shrinkage findings of previous studies were not confirmed by recent data, according to documents posted online, the news agency said. |