MADRID, September 22, 2016 /PRNewswire/ -- PharmaMar (MSE:PHM) has announced today 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). This is a type of blood cancer which represents 10% of all hematological malignancies.
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.
The submission of this MMA to the EMA represents an important milestone for PharmaMar. "We have achieved positive results with this molecule throughout its clinical development and we believe Aplidin® could become a novel therapeutic alternative for patients with multiple myeloma", says Luis Mora, Managing Director of PharmaMar´s Oncology Business Unit, who also adds "that we estimate the answer from the regulatory agency for the second half of 2017".
Read more: http://www.prnewswire.co.uk/news-releases/pharmamar-submits-maa-to-ema-for-aplidin-for-the-treatment-of-multiple-myeloma-594387731.html