Genentech Submits NDA for Skin Cancer Drug Vismodegib

Biotechnology firm Genentech has submitted a NDA for vismodegib to the FDA for the treatment of advanced basal cell carcinoma.

California-based biotechnology corporation Genentech, a member of the Roche Group, has submitted a NDA for vismodegib to the FDA for the treatment of advanced basal cell carcinoma (BCC), when surgery is considered inappropriate.

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. BCC is the most common type of skin cancer, and is generally considered curable by surgery. However, when it advances, BCC can cause disfiguring and debilitating effects and can ultimately be life-threatening.

This submission to the FDA is based on results from the ERIVANCE BCC study that evaluated vismodegib in people with advanced BCC.