publication date: May. 1, 2015

Thumbs Up on Amgen’s T-VEC to Treat Melanoma; Is it Local Therapy for Systemic Disease?


NCI surgeon Richard Sherry tried unsuccessfully to refocus FDA’s approval question.



An FDA advisory committee April 29 recommended approval of a metastatic melanoma treatment based on an attenuated Herpes Simplex Virus-1.

In a joint meeting, the agency’s Oncologic Drugs Advisory Committee and its Cellular, Tissue, and Gene Therapies Advisory Committee voted 22 to 1 to recommend full approval for talimogene laherparepvec, sponsored by Amgen Inc.

At the contentious all-day meeting, which ran twice as long as a standard session of ODAC, the unusually large group of advisors summoned by the FDA didn’t get the opportunity to clearly identify the group of patients who stand to benefit from the agent, also called T-VEC, or specify the agent’s place in a sequence of melanoma treatments.

One panel member—NCI surgeon Richard Sherry—pressed to narrow the indication, which, according to data, is active in cutaneous lesions and less active (or inactive) in visceral disease.

“Does it further the discussion or weaken the discussion not to step up to the plate and define whom this makes sense in?” Sherry said. “You can’t just leave it open.”

In explanation of their votes on the single approval question, several committee members said they would have been more comfortable had the questions been broken … Continue reading 41-17 Thumbs Up on Amgen’s T-VEC to Treat Melanoma; Is it Local Therapy for Systemic Disease?

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