Myeloma Patients Europe (MPE) has written to the Chair of the Committee for Human Medicinal Products for Human Use (CHMP) within the European Medicines Agency (EMA) to provide the patient viewpoint on the importance of plitidepsin (Aplidin®) for relapsed and refractory myeloma patients across Europe. We have outlined how important it is for patients across Europe to gain access to effective drugs that have new mechanisms of action.
Our letter was triggered by reading headlines in Spanish press that the manufacturer of plitidepsin (Pharma Mar) recently informed the Comisión Nacional de Mercado de Valores (CNMV – the Spanish stock market commission) that a negative trend vote is expected from the CHMP on their assessment of plitidepsin in combination with dexamethasone for the treatment of relapsed and refractory myeloma.
As the final meeting of the CHMP committee is still to take place, MPE has taken definitive action to reemphasise the importance of the treatment for myeloma patients to the CHMP committee and to urge approval. You can read our letter here.
Given rules around confidentiality, it is not yet known why the CHMP is trending a negative vote. MPE will be following the decision with interest and will keep our members updated. If you have any questions in the meantime, please email email@example.com
Plitidepsin is an investigational drug for the treatment of relapse and refractory myeloma.
It is a first-in-class drug specifically targeting eEF1A2 in myeloma cells and is of marine origin. The Phase III licensing trial, known as ADMYRE, looked at plitidepsin in combination with dexamethasone vs dexamethasone in relapsed and/or refractory myeloma. Whilst the final results of the data are due to be presented at the American Society of Hematology (ASH) Annual Meeting in 2017, results published to-date have shown good anti-myeloma effect, with a 35% reduction in the risk of relapse in patients compared to the comparator. It is also being looked at in a Phase III trial in combination with bortezomib (Velcade®) and dexamethasone in relapsed myeloma.