Article
Independent Committee Recommends T-Vec for Approval Despite FDA Staff Concerns
Amgen might be the latest entrant in the immunotherapy realm if the FDA heeds the advice of an independent advisory panel, recommending Amgen's anticancer viral therapy, T-Vec, for melanoma treatment.
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 FDA 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 2 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.
Complete article on Reuters: http://reut.rs/1bgix4y
