EC grants conditional marketing authorization to linvoseltamab for RRMM

On April 28, 2025, the European Commission (EC) granted conditional marketing authorization to linvoseltamab, a B-cell maturation antigen (BCMA)-directed bispecific antibody therapy, for the treatment of adult patients with relapsed/refractory multiple myeloma (RRMM) and ≥3 prior therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody, with progression on the last therapy.¹

The approval was based on data from the phase I/II LINKER-MM1 (NCT03761108) trial with 200 mg dosing and represents the first regulatory approval for a BCMA-directed therapy that can be administered every 4 weeks under a response-adapted regimen, provided a very good partial response or better is achieved after at least 24 weeks of treatment.¹

LINKER-MM1 pivotal data¹

• The objective response rate for linvoseltamab 200 mg was 71%, with a 50% rate of complete response (CR) or better.
• The measurable residual disease negativity rate among patients who experienced a CR or better was 41%.
• The median duration of response was 29 months.
• The most common adverse reaction was musculoskeletal pain, recorded in 52% of patients.
• Cytokine release syndrome was reported in 46% of patients, with the majority being Grade 1 (35%) or Grade 2 (10%).
• Neutropenia was observed in 43% of patients. Other common adverse events included cough (42%), diarrhea (39%), anemia (38%), fatigue (36%), pneumonia (32%), and upper respiratory tract infection (30%).
• Serious infections (Grade 3 or 4) occurred in 36% of patients, while fatal infections were reported in 4%.