After two first positive judgments, a scientific study at the world's largest blood cancer congress ("ASH") in December 2017, appeals from the "Mieloma España" and "Myeloma Patients Europe" patients association and finally the refusal of medicines European Agency (EMA). At last some questions addressed to the European Parliament by Spanish exponents (Socialists and Democrats and EPP of the European People's Party).
The heart of the matter is a drug against multiple myeloma based on "plitidepsin", produced by a Spanish company (at the moment the only therapies come from the United States and Japan). In the report on the preliminary authorization and subsequent review, there was an initial judgment by the EMA specialists and a final refusal on the statistical methodology of the phase III study ("ADMYRE"), presented at the 'ASH' Congress 2017: the benefits of the combination of the drug with dexamethasone, the statistically significant increase in Progression Free Survival (PFS) and 2,7 months advantage in OS (p=0,12) and the few side effects. The molecule, pending approval in Australia, New Zealand, Israel, Korea and Switzerland, was, therefore, the subject of 3 parliamentary questions, to clarify the process.
"Myeloma Patients Europe" sent a letter to the CHMP last December: "Data from the Phase I-III clinical trial and the experience of haematologists show that patients respond well to plitidepsin in combination with dexamethasone. Plitidepsin has been shown to develop responses in patients who have been pre-treated with a range of existing treatments. The intravenous administration method is acceptable. We sincerely hope that the CHMP is willing to guarantee plitidepsin a positive recommendation, only by ensuring the approval of new and promising treatments for myeloma patients across Europe, we can maintain survival rates in myeloma on an upward trajectory".