Skin cancer immunotherapy recommended in spite of clinical uncertainties
Skin cancer immunotherapy recommended in spite of clinical uncertainties29 Apr 2015
Amgen’s skin cancer immunotherapy showed enough efficacy in the treatment of melanoma to be given marketing approval, according to an independent advisory panel to the U.S. Food and Drug Administration.
Doubts around the results of the key study
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.
Company’s response on the expressed concerns
The FDA reviewers had already commented that it was unclear if the treatment improved overall survival of patients.
In the opinion of Amgen, T-Vec was more effective in melanoma patients whose cancer had not spread to internal organs.Source: Reuters