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Erivedge Efficacy Overcomes Limitations Of Single-Arm Study

 
• By Sue Sutter

Response rates of 30%-43% and a 7.6-month median duration of response were sufficiently clinically meaningful to allow FDA approval of Genentech’s basal cell carcinoma treatment on the basis of a non-randomized study.

FDA has been encouraging oncology drug sponsors to move away from pursuing initial approval based on single-arm studies, but in the case of Genentech Inc.’s Erivedge (vismodegib) the agency harbored little concern about approving the basal cell carcinoma drug on the basis of such a limited data package once it saw the pivotal trial results.

The adequacy of the clinical efficacy data – comprising a single-arm trial, a limited number of patients and a primary...

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More from North America

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