Plitidepsin (Aplidin®), a new medicine for the treatment of relapsed and refractory myeloma, has today received a second negative recommendation from the Committee for Medicinal Products for Human Use (CHMP). This decision means that plitidepsin is very unlikely to made available to patients across Europe.
This upholds a previous negative recommendation from the CHMP, which was reviewed following an appeal by the pharmaceutical company Pharma Mar.
Ananda Plate, Myeloma Patients Europe (MPE) CEO commented:
“This is a disappointing decision for myeloma patients. However, following an extensive review by the CHMP, they remain unconvinced that survival benefits of the medicine outweigh the risks. Whilst MPE considers there to be a place in the myeloma pathway for plitidepsin, we respect the decision of the CHMP and commend their involvement of patients in the appeal process. We hope PharmaMar continues to explore the benefits of plitidepsin in combination with other medicines and in other stages of the disease given the promising early results.”
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