Plitidepsin (Aplidin®), a new medicine for the treatment of relapsed and/or refractory myeloma, has today received a negative recommendation from the Committee for Medicinal Products for Human Use (CHMP). The decision means that, as it stands, plitidepsin is unlikely to be made available for myeloma patients across Europe.
This news comes despite a letter, sent to the Chair of the CHMP by Myeloma Patients Europe (MPE), outlining its importance for myeloma patients.
Ananda Plate, CEO of MPE, commented: “This news is obviously very disappointing for myeloma patients across Europe. MPE is now working to establish the reasons why plitidepsin has received a negative opinion from the CHMP, following positive results from the Phase III clinical trial ADMYRE, and will continue to work to ensure the patient and carer voice is heard in the decision-making.”
What is the CHMP?
The CHMP is the scientific advisory committee of the European Medicines Agency (EMA), the European licensing body. It provides advice to the European Commission on new medicines going through the licensing process and whether they should be granted marketing authorisation across Europe. Their assessment is based on whether a drug is safe and effective enough to be used in patients.
What does the decision mean?
Whilst it works in an advisory capacity, the European Commission typically adopts the advice of the CHMP committee. The CHMP decision means that, as it stands, plitidepsin is unlikely to be made available to myeloma patients across Europe.
What is plitidepsin?
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. Data recently published at the 2017 American Society of Haematologists (ASH) Annual Meeting highlighted that plitidepsin improves overall survival in myeloma patients compared to dexamethasone with minimal impact on quality of life. You can see the full results of the clinical trial here:
It is also being looked at in a Phase III trial in combination with bortezomib (Velcade®) and dexamethasone in relapsed myeloma.
What are the next steps?
MPE is working to understand why the CHMP committee has issued a negative decision on plitidepsin.
Given the negative decision, it is likely that the pharmaceutical company PharmaMar will appeal the decision. If this is the case, there will be further opportunity for MPE to provide the patient perspective to the CHMP.
Where can I find further information?
To further understand the decision, you can read the EMA news release here.