EMA to assess marketing authorisation application from PharmaMar for Aplidin

Multiple myeloma is a relatively uncommon type of blood cancer, which accounts for 10% of all haematological malignancies

PharmaMar has announced that the European Medicines Agency (EMA) has accepted to assess the Marketing Authorization Application (MAA) for Aplidin (plitidepsin) in combination with dexamethasone for the treatment of relapsed/refractory multiple myeloma (MM).

PharmaMar submitted the above mentioned application for the antitumor drug of marine origin, Aplidin, in combination with dexamethasone given the positive results obtained from the ADMYRE study. Plitidepsin could be a therapeutic alternative for patients suffering from relapsed and/or refractory multiple myeloma.

After this acceptance, the EMA is going to start the assessment of this potential treatment for a type of blood cancer, which accounts for 10% of all haematological malignancies.

The ADMYRE clinical trial is a randomised, Phase III study 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 compared with the comparator. The study met its primary endpoint.

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