FDA Advisory Committee to review T Vec (talimogene laherparepvec) for Metastatic Melanoma on 29 April 2015- Amgen

Amgen has announced that the Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC) and the Oncologic Drugs Advisory Committee (ODAC) of the FDA will jointly review the Company's Biologics License Application (BLA) for talimogene laherparepvec. The FDA is currently reviewing the talimogene laherparepvec BLA for the treatment of patients with injectable regionally or distantly metastatic melanoma. The advisory committees will review talimogene laherparepvec at a meeting on April 29, 2015.

Comment:T-Vec increased overall survival by four months compared to standard growth factor therapy. In interim results, patients taking T-Vec, posted a median overall survival rate of 23.3 months, beating the 19 months for those treated with the white blood cell-spurring GM-CSF. The virus, designed to infect tumour cells and lead an attack by the immune system, had a particularly strong effect on patients with stage IIIB, IIIC or IV melanoma and on those taking T-Vec as a first-line treatment.