April 27 (Reuters) – The U.S. Food and Drug Administration should not consider an accelerated review of Amgen Inc’s marketing application for its skin cancer vaccine, FDA staff reviewers concluded in documents released on Monday, citing concerns over the design and results of a key study.
The review comes two days before a panel of FDA advisers votes on whether the treatment, a cancer-killing virus called talimogene laherparepvec or “T-Vec”, should be approved to treat melanoma.
The reviewers also said it was unclear whether T-Vec improved overall survival, raising questions over the drug’s effectiveness.
The panel is scheduled to discuss the late-stage study on Wednesday, including whether the trial’s main goal of showing an improvement in the durable response rate was meaningful. (http://1.usa.gov/1djTiQs)
The FDA typically accepts the panel’s recommendations.
The staff review is the second setback for T-Vec, after the FDA in February pushed back a decision on approving the drug to Oct. 27, citing the need for more data.
Amgen’s shares were little changed in early trading on the Nasdaq.
(Reporting by Anjali Rao Koppala and Vidya L Nathan in Bengaluru; Editing by Simon Jennings)