Genentech Submits NDA for Skin Cancer Drug

Genentech 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.

“We are excited by the pivotal study results that showed vismodegib substantially reduced tumor size or healed lesions for people with this rare skin cancer, which has no approved treatments,” said Hal Barron, M.D., chief medical officer and head, Global Product Development. “We look forward to continuing our discussions with the FDA about these data.”

This submission to the FDA is based on results from the ERIVANCE BCC study that evaluated vismodegib in people with advanced BCC. The trial showed vismodegib substantially shrank tumors or healed visible lesions in 43% of patients with locally advanced BCC and 30% of patients with metastatic BCC. The median duration of progression-free survival (PFS) by independent review for both metastatic and locally advanced BCC patients was 9.5 months.