Genentech announced that the FDA has accepted its New Drug Application (NDA) for vismodegib for the treatment of adults with advanced basal cell carcinoma (BCC) for whom surgery is considered inappropriate. The application has been granted Priority Review status and the FDA confirmed the action date is March 8, 2012.
The vismodegib application is based on results from the pivotal ERIVANCE BCC study. The trial showed vismodegib substantially shrank tumors or healed visible lesions (objective response rate [ORR]) in 43% of patients with locally advanced BCC (laBCC) and 30% of patients with metastatic BCC (mBCC), as assessed by independent review, the primary endpoint of the study. The ORR as assessed by study investigators, a secondary endpoint, was 60% for laBCC and 46% for mBCC. The median progression-free survival by independent review for both metastatic and locally advanced BCC patients was 9.5 months.
Vismodegib is an investigational, oral, targeted medicine designed to selectively inhibit signaling in the Hedgehog pathway, which is implicated in more than 90% of BCC cases.
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