Torisel gets CHMP positive opinion

EMEA's CHMP issued a positive opinion on an MAA for Torisel temsirolimus from Wyeth (WYE) as first-line treatment for patients with advanced renal cell carcinoma (RCC) who have at least three of six prognostic risk factors. The rapamycin derivative mTOR kinase inhibitor has Orphan Drug designation in the EU and Orphan Drug status in the U.S., where it was approved for the indication in May. WYE expects a final decision from the EC in November. ...