Aplidin (plitidepsin) filed with EMA for multiple myeloma - PharmaMar

PharmaMar has announced the submission to the European Medicines Agency (EMA) of the Marketing Authorization Application (MAA) for Aplidin (plitidepsin) in combination with dexamethasone for the treatment of relapsed/refractory multiple myeloma (MM). PharmaMar has gone through with this application given the positive data obtained from the randomized, Phase III ADMYRE clinical trial, where the efficacy and safety of Aplidin with dexamethasone versus dexamethasone alone in patients with relapsed/refractory MM after at least three, but no more than six, prior therapeutic regimens has been evaluated. The results of the ADMYRE study showed a statistically significant 35% reduction in the risk of progression or death over the comparator. The study met its primary endpoint.

Comment: Plitidepsin is currently in clinical development for hematological cancers, including a Phase Ib trial in relapsed or refractory multiple myeloma as a triple combination of plitidepsin, bortezomib and dexamethasone, and a Phase II study in relapsed or refractory angioimmunoblastic T-cell lymphoma. Plitidepsin has received orphan drug designation in the European Union and the United States of America.