EMA Recommends Full Approval of Melflufen for MM

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use issued a positive opinion recommending a full marketing authorization approval of melphalan flufenamide (also called melflufen) in the European Union for patients with triple-class refractory multiple myeloma (MM).

The recommendation is based on data from the phase II HORIZON study and is supported by data from the randomized, controlled, phase III OCEAN study.

Melflufen is indicated, in combination with dexamethasone, for the treatment of adult patients with MM who have received at least three prior lines of therapies; whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one anti-CD38 monoclonal antibody; and who have demonstrated disease progression on or after the last therapy. For patients with a prior autologous hematopoietic stem cell transplantation, the time to progression should be at least three years from transplantation.

The European Commission (EC) will make a legally binding decision based on the EMA recommendation within 60 days. Once granted by EC, the marketing authorization is valid in all EU member states, as well as in the European Economic Area countries, Iceland, Lichtenstein, and Norway.

Source: PR Newswire via Oncopeptides AB, June 2022