Curis, Inc. (NASDAQ: CRIS), a drug development company seeking to develop next generation targeted small molecule drug candidates for cancer treatment, today announced that the U.S. Food and Drug Administration (FDA) has accepted and filed for review Genentech's new drug application (NDA) for vismodegib for the treatment of adults with advanced basal cell carcinoma (BCC) for whom surgery is considered inappropriate. Vismodegib (GDC-0449, RG3616) is a first-in-class, investigational, oral medicine designed to selectively inhibit signaling in the Hedgehog pathway and is being developed by Genentech, a member of the Roche group, under a collaboration agreement with Curis.
The vismodegib NDA has been granted priority review by the FDA. The FDA grants priority review status to products that, if approved, would address an unmet medical need or are considered to be potentially significant therapeutic advancements over existing approved therapies in the treatment, diagnosis or prevention of a disease. The FDA has established March 8, 2012 as the action date under the Prescription Drug User Fee Act (PDUFA) to complete its review of the NDA and potentially grant marketing approval of vismodegib.
Curis earned an $8 million milestone payment from Genentech as a result of FDA's acceptance of the NDA submission. If vismodegib receives FDA approval, Curis will also be entitled to receive an additional milestone payment as well as royalties on any future sales.
"We are extremely pleased that the FDA has accepted the vismodegib NDA for review and that the submission will receive priority review," said Dan Passeri, Curis President and Chief Executive Officer. "With no currently approved treatments for advanced basal cell carcinoma, this brings vismodegib one step closer to being an important treatment and the only approved pharmacologic treatment for those suffering from this serious disease."
The application is based on clinical data from ERIVANCE BCC/SHH4476g, a pivotal Phase II study of vismodegib in patients with advanced basal cell carcinoma.