FDA OKs melanoma drug after denying it accelerated approval

Two days after it reported that the Food and Drug Administration had denied accelerated approval to Amgen experimental melanoma drug talimogene laherparepvec (T-Vec), Reuters reported that an FDA advisory panel voted to approve the drug for marketing.

Dermatology Timesdiscussed the approval with Wm. Philip Werschler, M.D., FAAD, FAACS, Associate Clinical Professor at University of Washington School of Medicine in Seattle, Wash.

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"Globally, the treatment of melanoma has advanced greatly in the past 5 years. It appears that we are on the cusp of significant success in the medical management of melanoma, something that heretofore was the domain of surgical management.

Because of the culmination of many decades of dedicated research on the genetics and biological behavior of melanoma, and tumor response to various medical interventions, today there exists a variety of anti-tumor drug options of various types and classes. The medical oncologist, in consultation with dermatologists, internists and surgeons is at the same time fortunate and bewildered in terms of selecting the best and most efficacious and most appropriate drug therapy option(s) for the individual melanoma patient. Truly, the era of personalized medicine is upon us with regard to melanoma therapy.

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The seemingly confusing about-face of the FDA with regard to Amgen's T-Vec investigational drug perhaps is better examined in the perspective of a very rapidly changing landscape of melanoma therapy. I applaud the FDA for having the insight and courage to face criticism and be willing to reexamine facts to arrive at a different conclusion from one reached just days earlier."

NEXT: FDA staff review of T-Vec

Reuters reported April 27 that FDA staff reviewers said they could not consider an accelerated review of T-Vec-an engineered virus that kills cancer cells when injected into tumors and primes the immune system to attack the disease-due to concerns over the design and results of a key study. Specifically, an independent panel said it questioned whether the immunotherapy improved overall survival of patients.

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Also on April 27, Medical Marketing & Media reported that the recent approval of drugs such as Merck’s Keytruda and Bristol-Myers Squibb’s Opdivo-unavailable when Amgen started testing in 2009-reduced the urgency of an accelerated-approval designation for T-Vec. According to MM&M, Amgen and Merck signed a deal last year to explore how T-Vec worked with PD-1 inhibitor Keytruda.

Then, on April 29, Reuters reported the FDA’s ruling that T-Vec had shown enough efficacy to earn marketing approval. According to another report by Medscape Medical News, the recommendation for approval came from two advisory panels: the Oncologic Drugs Advisory Committee and the Cellular, Tissue and Gene Therapies Advisory Committee, members of which voted 22-1 to approve.

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T-Vec contains a genetically modified version of the herpes simplex virus, engineered to replicate in the tumor and destroy cancer cells.

The drug also is being considered for approval in the European Union.