Genentech files with US FDA for vismodegib in rare form of advanced skin cancer

In a second filing for a novel skin cancer drug this year, Swiss drug major Roche (ROG: SIX) US subsidiary Genentech has submitted a New Drug Application for vismodegib to the US Food and Drug Administration for the treatment of people with advanced basal cell carcinoma (BCC) for whom 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 the cases of BCC, the most common type of skin cancer, which is generally considered curable by surgery. However, when it advances, BCC can cause disfiguring and debilitating effects and can ultimately be life-threatening.

The drug candidate was discovered by Genentech but was validated in preclinical trials by partner Curis (Nasdaq: CRIS), which stands to receive an $8 million milestone payment if the FDA accepts the submission for review, and additional payments if vismodegib is ultimately approved. Curis would also receive royalties on sales. The drug is licensed to Chugai, a majority Roche owned company, in Japan.