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 outcome measure based on response rate – was cited as...