Erivedge Efficacy Overcomes Limitations Of Single-Arm Study
This article was originally published in Pharmaceutical Approvals Monthly
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.
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For more than 15 years, the Pink Sheet's Drug Review Profile series has looked closely at FDA approval documents, providing a long view of the pitfalls and pitches presented in the NEJM series on interpreting clinical trial results.
A pivotal trial with a control arm was necessary to evaluate a hepatotoxicity signal with Genentech’s Kadcyla, helping to derail a bid for accelerated approval based on a single-arm Phase II trial. Genentech’s strategy of running trials in different lines of treatment concurrently enabled a quick strategy shift as an ongoing controlled Phase III trial in another line was amended to meet FDA’s regulatory requests.
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