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PharmaMar submits MAA to EMA for Aplidin for the treatment of multiple myeloma

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Additional Relevant Details 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.
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Catalyst Date
Occurred on:
Sep 22, 2016
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Related Keywords Aplidin, Plitidepsin, Dexamethasone, Relapsed/refractory Multiple Myeloma, Admyre Clinical Trial