Progress toward immunotherapy treatments for melanoma advanced another step with near-unanimous support from FDA advisors for Amgen Inc’s talimogene laherparepvec (T-VEC). An oncolytic virus immunotherapy, T-VEC has been developed for patients with injectable regionally or distantly metastatic melanoma. If approved, it will be the first product in a new class of drugs, oncolytic immunotherapies.
Regulatory
FDA Grants Priority Review to Frontline Nivolumab in Melanoma
The FDA has assigned a priority review designation to the PD-1 inhibitor nivolumab (Opdivo) as a treatment for previously untreated patients with unresectable or metastatic melanoma. Under the expedited process, the action date for the FDA’s decision is August 27, 2015.
FDA panel backs Amgen’s T-Vec for melanoma
An FDA advisory committee has voted in favour of approving Amgen’s virus-like melanoma therapy, despite questions about its impact on survival.
FDA Panels Support Approval of T-VEC in Melanoma
In a combined decision, members of the FDA’s Oncologic Drugs Advisory Committee (ODAC) and Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC) voted 22-1 to recommend approval of the oncolytic immunotherapy talimogene laherparepvec (T-VEC) as a treatment for patients with advanced melanoma. A final approval decision from the FDA is scheduled by October 27, 2015.