Unlike FDA panel, CHMP backs AZ's olaparib

EMA's CHMP recommended marketing authorization of Lynparza olaparib from AstraZeneca plc (LSE:AZN; NYSE:AZN) as maintenance treatment of platinum-sensitive relapsed ovarian, fallopian tube or peritoneal cancer in patients with germline breast cancer early onset (BRCA) mutations who are responding to platinum-based chemotherapy. If approved, the therapy would be the first poly(ADP-ribose) polymerase ( PARP) inhibitor available in the indication.

CHMP based its recommendation on the results of the Phase II Study 19, which showed that olaparib increased progression free survival (PFS) by 7.1 months compared to placebo. ...