First oncolytic immunotherapy medicine recommended for approval in EU

The European Medicines Agency’s scientific committee on Friday recommended authorizing Imlygic (talimogene laherparepvec) for the treatment of adults with melanoma that cannot be removed by surgery and that has spread either to the surrounding area or to other areas of the body (regionally or distantly metastatic) without affecting the bones, brain, lung or other internal organs.

Imlygic, from US biotech giant Amgen (Nasdaq: AMGN), is a first-in-class advanced therapy medicinal product (ATMP) derived from a virus, that has been genetically engineered to infect and kill cancer cells. It is administered via intralesional injection and designed to cause the death of tumor cells. The recommendation was made by the Committee for Medicinal Products for Human Use (CHMP) based on an assessment carried out by the Committee for Advanced Therapies (CAT), the Agency’s expert committee for ATMPs. Amgen’s shares rose 2.26% to $155.75 by close of trading on the Nasdaq on Friday.

“We are pleased that Imlygic has received a positive opinion from the CHMP, and if approved by the European Commission, we look forward to continuing to work with European regulatory authorities to bring this innovative therapy to patients,” said Sean Harper, executive vice president of R&D at Amgen. “Metastatic melanoma continues to be one of the most difficult-to-treat cancers, often requiring the use of multiple treatment modalities. Despite recent advances, the five-year survival rate for patients who cannot be cured with surgery remains unacceptably low, demonstrating the critical need for additional approaches to control this disease,” Dr Harper added.