The CHMP recommended granting a conditional marketing authorisation for Lynozyfic (linvoseltamab) for the treatment of patients with relapsed and refractory multiple myeloma
On 27 February 2025, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional marketing authorisation for the medicinal product Lynozyfic (linvoseltamab), intended for the treatment of patients with relapsed and refractory multiple myeloma who have received at least three prior therapies.
The full indication is:
Lynozyfic is indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least 3 prior therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.
The applicant for this medicinal product is Regeneron Ireland DAC.
Lynozyfic will be available as a 5 mg or 200 mg concentrate for solution for infusion. The active substance of Lynozyfic is linvoseltamab, a bispecific monoclonal antibody (ATC code: not yet assigned). Lynozyfic targets CD3, a receptor expressed on the surface of T cells, and BCMA, expressed on the surface of plasma cells, including malignant multiple myeloma cells.
The benefit of Lynozyfic is its ability to induce a partial or complete response in patients with relapsed or refractory multiple myeloma, as shown in a phase 2, open-label study.
The most common side effects with Lynozyfic are musculoskeletal pain, cytokine release syndrome, neutropenia, cough, diarrhoea, anaemia, fatigue, pneumonia and upper respiratory tract infection.
Treatment with Lynozyfic should be initiated and supervised by physicians experienced in the treatment of multiple myeloma.