28 octubre 2016

The EMA Accepts to Assess the Marketing Authorization Application from PharmaMar for Aplidin® .

Con esta aceptación se pone en marcha el proceso de evaluación en la EMA de este
posible tratamiento para un tipo de cáncer de la sangre que representa el 10% de
las neoplasias hematológicas malignas.

MADRID, October 28, 2016 /PRNewswire .

PharmaMar (MSE: PHM) has announced today 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 hematological malignancies.
The ADMYRE clinical trial is a randomized, 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 bee
n 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.