BioCentury
ARTICLE | Regulation

Getting the message in melanoma

How subgroup data helped FDA panel recommend Amgen's T-Vec in melanoma

May 4, 2015 7:00 AM UTC

Initial hand-wringing by FDA reviewers over the statistical robustness and meaningfulness of efficacy data for Amgen Inc.'s talimogene laherparepvec faded away last week when an FDA advisory committee saw a subset of patients they thought received clear benefit, including a suggestion of greatly improved survival.

At the beginning of the meeting, FDA reviewers presented a litany of concerns over the study design and clinical benefit shown in Amgen's lone Phase III trial. The product, T-Vec, met the primary endpoint of durable response rate but narrowly missed the secondary endpoint of overall survival...