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Genentech goes beyond Infinity with FDA OK to sell Hedgehog inhibitor for advanced BCC

 
• By Daniel B Moskowitz

Well ahead of its PDUFA deadline of 8 March, the US FDA on January 30 gave Roche's Genentech arm the green light to sell vismodegib as the first nonsurgical treatment for advanced basal cell carcinoma (BCC). The company said that the once-a-day capsule will be on the US market under the trade name Erivedge before mid-February. Last month Roche filed for approval of the drug with the EMA (scripintelligence.com, 23 December 2011). It is intended for the small group of BCC patients for whom the condition is not treated soon enough or in whom it returns in the same location after treatment.

Well ahead of its PDUFA deadline of 8 March, the US FDA on January 30 gave Roche's Genentech arm the green light to sell vismodegib as the first nonsurgical treatment for advanced basal cell carcinoma (BCC). The company said that the once-a-day capsule will be on the US market under the trade name Erivedge before mid-February. Last month Roche filed for approval of the drug with the EMA (scripintelligence.com, 23 December 2011). It is intended for the small group of BCC patients for whom the condition is not treated soon enough or in whom it returns in the same location after treatment.

Genentech’s fortunes contrast with those of Infinity Pharmacuticals which recently halted a Phase II trial of its experimental Hedgehog pathway...

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