Erivedge May Be The Gleevec Of Hedgehog Inhibitors
FDA approval of Curis/Genentech’s hedgehog inhibitor Erivedge validates the class, but basal cell carcinoma is only the ante; cancers exploit hedgehog signaling in a variety of ways yet to be elucidated.
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The Lexington, Mass.-based oncology specialist seeks to resume enrollment in a Phase I trial halted after a patient death, while a revenue-generating drug partnered with Genentech could soon have a new competitor.
The review division and CDER senior staff supported approval of Genentech’s highly teratogenic, basal cell carcinoma treatment vismodegib without a Risk Evaluation and Mitigation Strategy, but the Division of Risk Management believed a communications plan should be carried out under a REMS for the first-in-class Hedgehog pathway inhibitor.
Roche put up improved sales figures reflecting a 9% increase in oncology sales so far in 2012 and elaborated on its plan for continued growth in the face of eventual generic competition.