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news.Genentech has filed a new drug application (NDA) with the US Food and Drug Administration (FDA) for its experimental drug vismodegib as a treatment for the patients with advanced basal cell carcinoma (BCC) for whom surgery is inappropriate.
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The filing of the NDA is backed by the results from a multicenter, two-cohort, single-arm, open-label Phase II Erivance BCC study that investigated vismodegib in patients with advanced BCC.
The results of the trial demonstrated that 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).
Genentech is developing vismodegib under a collaboration agreement with Curis.