The European Medicines Agency (EMA) has issued a second negative recommendation for plitidepsin (Aplidin®) in combination with dexamethasone for the treatment of relapsed and refractory myeloma.
The application to authorise this treatment combination was re-examined by the EMA after receiving an initial negative recommendation in December 2017. This decision was based upon data from the Phase III ADMYRE trial which demonstrated that plitidepsin and dexamethasone led to improved overall survival in myeloma patients who had received 3 – 6 prior treatments, compared to dexamethasone alone. However, the EMA did not find the survival benefit to be significant, particularly when more severe side-effects were reported among patients receiving plitidepsin.
Plitidepsin is currently being investigated in a Phase I trial in combination with pomalidomide (Imnovid®), bortezomib (Velcade®) and dexamethasone for newly diagnosed myeloma patients.