The controversial cancer drug Avastin becomes the focus of U.S. regulators’ attention again Tuesday during a two-day hearing to determine if the medication can keep its FDA approval for the treatment of metastatic breast cancer.
Back on Dec. 16, the U.S. Food and Drug Administration recommended revoking approval of the drug to fight breast cancer, citing the medication’s poor performance in follow-up studies and its potential for serious side effects.
The drug’s maker, Genentech, now owned by the pharmaceutical giant Roche, was given the chance to appeal the FDA recommendation and present additional evidence. That appeal will be the focus of the hearing and, according to published reports, will involve Genentech urging one more clinical trial before any government action on the drug.
The FDA’s unusual step of scheduling another hearing on the drug underscores the difficulty of withdrawing approval of a cancer medication.