News Summary: FDA backs early-stage cancer drug

AP News
Posted: Sep 10, 2013 5:42 PM

ACCELERATED APPROVAL: Government scientists on Tuesday recommended speedy approval for a Roche breast cancer drug that could become the first pharmaceutical product approved for use before surgery.

NEW OPTION: Preliminary results submitted by Roche showed that women who received the drug Perjeta were more likely to be cancer-free than women receiving older drug combinations.

COMMITTEE OPINION: On Thursday, the FDA will ask an outside panel of cancer specialists whether Perjeta's benefits outweigh its risks for treating early-stage breast cancer. The vote is non-blinding but factors into the FDA's decision.