CHMP backs Xtandi, Erivedge, Nuedexta
EMA's CHMP issued a number of positive recommendations on Friday, including a recommendation to approve an MAA from Astellas Pharma Inc. (Tokyo:4503) for Xtandi enzalutamide to treat metastatic castration-resistant prostate cancer (CRPC) in men whose disease has progressed on or after docetaxel therapy. FDA approved the oral androgen receptor antagonist for the indication last August. Astellas and Medivation Inc. (NASDAQ:MDVN) partnered to develop and commercialize Xtandi in 2009. Medivation was up $0.36 to $52.38 on Friday.
CHMP also recommended conditional approval of an MAA from Roche (SIX:ROG; OTCQX:RHHBY) for Erivedge vismodegib to treat adults with metastatic or locally advanced basal cell carcinoma (BCC) for whom surgery or radiation are considered inappropriate. The recommendation was based on data from the open-label Phase II ERIVANCE BCC trial in 104 patients with inoperable advanced BCC. Last January, FDA granted full approval to Erivedge based on the same data. Roche's Genentech Inc. unit discovered the small molecule hedgehog pathway inhibitor and jointly validated the compound with Curis Inc. (NASDAQ:CRIS) in preclinical studies. Curis was up $0.37 to $3.78 on Friday. ...