Genentech, a subsidiary of Roche Holding AG (ROG.VX, RHHBY.PK), Wednesday reported the acceptance by the US Food and Drug Administration, or FDA, of its new drug application, or NDA, for vismodegib as a therapy for basal cell carcinoma in adults who cannot undergo surgery. The company also reported the application receiving a Priority Review status, with an action date of March 8, 2012.
The application is based on a Phase II study dubbed ERIVANCE which showed that vismodegib, which inhibits signaling in the Hedgehog Pathway, caused tumors to shrink substantially, or cured any visible lesions in basal cell carcinoma, or BCC patients. There are current FDA-approved medicines for BCC.
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