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 granting of conditional marketing authorization of Tepkinly (epcoritamab), a T-cell engaging bispecific antibody administered subcutaneously, as a monotherapy for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
