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news.Genentech, a member of the Roche Group, has announced the FDA approval of Erivedge (vismodegib) capsule for the treatment of adults with advanced basal cell carcinoma (BCC).
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Erivedge capsule, taken orally once-a-day, is the first FDA-approved medicine for people with advanced forms of the most common skin cancer.
The approval is based on results from ERIVANCE BCC (SHH4476g), a pivotal international, single-arm, multicenter, two-cohort, Phase II study.
The open-label study enrolled 104 patients with advanced BCC, including locally advanced BCC (71) and metastatic BCC (33).
The study showed Erivedge shrank lesions in 43% of patients with locally advanced BCC and 30% of patients with metastatic BCC, the primary endpoint of the study.
Genentech chief medical officer Hal Barron said the approval provides a new treatment for people with advanced basal cell carcinoma.