FDA joint advisory panel recommends T-Vec (talimogene laherparepvec) for treatment of metastatic melanoma- Amgen

A joint FDA Advisory Panel (Cellular,Tissue and Gene Therapy and Oncologic Drugs ) has voted to recommend approval to T-Vec (talimogene laherparepvec) from Amgen, voting 22-1 in favour that the drug has a favourable benefit risk ratio in metastatic melanoma but expressed reservations and rejected an accelerated approval. Some committee members were concerned that the phase III trial ( 005/05) showed a durable response (the percentage of patients whose melanomas did not grow for six months or longer) but not a convincing improvement in overall survival and they noted that the drug did better in early disease patients. The trial evidence showed only 16% of patients treated with T-Vec had a durable response but 33% of patients with Stage IIIB or IIIC of the disease (early disease) had a durable response.They were also concerned that the survival rate was not impressive: Patients taking T-VEC had a median overall survival of just 4.4 months longer than those taking GM-CSF.

After the panel adjourned Amgen stated that it would conduct further talks with the FDA as to how T Vec would be made available.

Comment: The development of T- Vec has taken time and there has been a dramatic change in the climate of treatment of metastatic melanoma with new classes of immunotherapy drugs, such as checkpoint inhibitors (Yervoy-BMS), BRAF inhibitors (Zelboraf- Genentech/Roche + Daiichi Sankyo) and programmed death 1 inhibitors (Opdivo- BMS) and Keytruda (Merck Inc.) that have shown highly positive results. A potential future for T-vec may be in combination therapy and trials with Yervoy and Keytruda are in progress.