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FDA Panel Recommends Approval for Amgen's Skin Cancer Immunotherapy

April 30, 2015

By Reuters Staff

Amgen Inc's skin cancer immunotherapy showed enough efficacy in the treatment of melanoma to be given marketing approval, an independent advisory panel to the U.S. Food and Drug Administration said on Wednesday.

The panel voted 22-1 supporting an approval for the therapy, talimogene laherparepvec or "T-Vec", an engineered virus that kills cancer cells when injected into tumors and also primes the immune system to attack the disease.

The recommendation comes two days after FDA staff expressed concerns over the design and results of a key study on T-Vec and raised questions over the interpretation of data from a late-stage study.

The FDA reviewers said on Monday that it was unclear if the treatment improved overall survival of patients.

Amgen said on Wednesday that T-Vec was more effective in melanoma patients whose cancer had not spread to internal organs.

More than 70,000 cases of melanoma are expected to be diagnosed in the United States this year, according to the National Cancer Institute.

Melanoma is the most aggressive form of skin cancer and the fifth most aggressive form of cancer.


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