Amgen faces a critical review for T-Vec

Amgen ($AMGN) took its best case for its dual cancer-killing oncolytic virus/cancer vaccine talimogene laherparepvec (T-Vec) to an FDA advisory committee this morning. But the morning reviews included a critical analysis from FDA reviewers who raised questions about the overall survival data as well as the company's claims related to statistically significant evidence of a durable response rate among patients. "The evidence that talimogene has a systemic effect was limited and difficult to calculate," FDA reviewer Robert Le told the committee. Amgen, though, is putting on a full court press today as it looks for a slate of new drug approvals this year. The committee will vote on the application this afternoon and the final decision will then be in the hands of the agency. Release (PDF)

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