FDA priority review for Roche/Genentech's vismodegib for skin cancer

The US Food and Drug Administration has accepted and filed Swiss drug major Roche (ROG: SIX) subsidiary Genentech’s New Drug Application for vismodegib for the treatment of adults with advanced basal cell carcinoma (BCC) for whom surgery is considered inappropriate. The application has been granted Priority Review status and the FDA confirmed the action date is March 8, 2012.

This further good news comes just shortly after Roche gained FDA approval for its Zelboraf (vemurafenib) in the treatment of BRAF V600E mutation-positive, inoperable or metastatic melanoma, as determined by an FDA-approved test, around three months earlier than expected (The Pharma Letter August 18).

"The priority review cuts the review length considerably," said Zuercher Kantonalbank analyst Michael Nawrath, quoted by the Wall Street Journal. "But even this shorter time span could be conservative." Analysts, on average, expect sales of less than $500 million for vismodegib in the basal cell carcinoma indication.