Roche's Erivedge gets conditional approval in EU for BCC
The European Commission conditionally approved an MAA from Roche (SIX:ROG; OTCQX:RHHBY) for Erivedge vismodegib to treat adults with symptomatic metastatic or locally advanced basal cell carcinoma (BCC) for whom surgery or radiotherapy are considered inappropriate. The approval was based on data from the open-label Phase II ERIVANCE BCC trial in 104 patients with inoperable advanced BCC. As part of the conditional approval, Roche will provide additional data from an ongoing, international safety trial of Erivedge in advanced BCC.
The approval triggers a $6 million milestone payment to partner Curis Inc. (NASDAQ:CRIS) from Roche's Genentech Inc. unit, which discovered the small molecule hedgehog pathway inhibitor and jointly validated the compound with Curis in preclinical studies. Curis was up $0.07 to $3.89 on Monday. ...