Elotuzumab receives a positive Committee for Medicinal Products for Human Use (CHMP) opinion for the treatment of multiple myeloma patients who have receive at least one prior therapy.
The reccommensation is based in the results of a randomised open-label Phase 3 study evaluating the use of elotuzumab in combination with lenalidomide and dexamethasone versus lenalidomide and dexamethashone alone. The results show that myeloma progresses more slowly on those patients who took elotuzumab compared to those who didn’t (difference in medians of 4.2 months).
Elotuzumab was already approved for the same indication by the US Food and Drug Administration (FDA) in 2015. The Committee’s decision brings over the availability of this new drug to the European patients. The application will be review by the European Commission which will ultimately have to decide on the final marketing authorisation. Once the authorisation is granted, each Member State will decide about price and reimbursement.
Elotuzumab is the first immune-based therapy to show benefit in the treatment of multiple myeloma. It works by stimulating the immune system to attack malignant cells by its mechanism as a SLAMF7 (CD319 positive) directed monoclonal antibody.
You can find more information on the European Medicines Agency (EMA) website.