NDA Submitted for Vismodegib for Basal Cell Carcinoma

Curis, Inc. and its collaborator Genentech, announced the submission of a new drug application (NDA) for vismodegib for the treatment of patients with advanced basal cell carcinoma (BCC) for whom surgery is considered inappropriate. This NDA submission to the FDA is based on results from the pivotal ERIVANCE BCC study that evaluated vismodegib in people with advanced BCC. The trial showed vismodegib substantially shrank tumors or healed visible lesions (overall response rate, or 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 duration of progression-free survival (PFS) by independent review for both metastatic and locally advanced BCC patients was 9.5 months.

Vismodegib is an investigational medicine designed to selectively inhibit abnormal signaling in the Hedgehog pathway, which is the underlying molecular driver of BCC. 

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