The Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended marketing authorization approval of Abecma (idecabtagene vicleucel; ide-cel) for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.
The European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a positive opinion recommending the approval of Sarclisa (isatuximab-irfc) in combination with bortezomib, lenalidomide, and dexamethasone, also called VRd, for the induction treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant. A final decision is expected in the coming months.
