Advisors to the US Food and Drug Administration will meet at the end of April to review Amgen’s closely-watched oncolytic immunotherapy T-Vec for melanoma.
The FDA’s Cellular, Tissue and Gene Therapies Advisory and Oncologic Drugs Advisory Committees will jointly review the company’s Biologics License Application for T-Vec, also known as talimogene laherparepvec, for the treatment of patients with injectable regionally or distantly metastatic melanoma. The meeting will take place on April 29 with a Prescription Drug User Fee Act (PDUFA) action date of October 27.
__T-Vec is injected directly into tumour tissue then replicates until the membrane of the cancer cells rupture, thereby destroying them. It was filed on the back of Phase III data which showed that T-Vec reached its primary endpoint with a 16% durable response rate and increased median overall survival rate to 4.4 months, though the latter fell slightly short of statistical significance.
Amgen R&D chief Sean Harper said that “the incidence of melanoma has continued to rise in recent years, and even with recent additional options in treatment, there is an important unmet medical need”. He added that “we look forward to discussing the efficacy and safety profile of talimogene laherparepvec with the advisory committees”.
T-Vec has generated much excitement, not least for its potential in combinations. In December, a trial combining the therapy with Merck & Co’s approved anti-PD-1 therapy Keytruda (pembrolizumab) began for advanced melanoma.