FDA Approves Linvoseltamab‍ for⁣ Multiple Myeloma

‍ ⁤ Updated July 03, ‍2025
⁢ ‍

the⁤ FDA has granted accelerated approval to linvoseltamab-gcpt (Lynozyfic, Regeneron⁤ Pharmaceuticals) for patients ⁣with relapsed or refractory multiple myeloma. The treatment is intended for those who have undergone⁢ at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and ⁤an anti-CD38 monoclonal⁣ antibody.

Linvoseltamab-gcpt is a bispecific ⁢B-cell ‍maturation antigen-directed‍ CD3 T-cell engager.

Sundar Jagannath, network director of the Center of Excellence for Multiple Myeloma at Mount Sinai, said the approval represents progress and the response-adapted dosing regimen could reduce treatment burden.

The approval stems from the phase 1/phase 2 LINKER-MM1 trial. The trial included 80 patients who had received at least four prior therapies.

The study’s ⁣primary measures were ⁤objective response rate ⁣and⁣ duration of response, assessed ‍using International‍ myeloma Working‍ Group criteria.

Results showed ⁢a 70% objective response rate (95% CI, 59%-80%), with 45% achieving a complete response or better. At a median follow-up of 11.3 months,the median duration of response was ⁣not reached. 89% remained in response at 9 months, and 72% at 12 months.

Common adverse ⁣effects included musculoskeletal pain, cytokine release syndrome, cough,⁢ upper respiratory⁣ tract infection, diarrhea, fatigue, pneumonia, nausea, headache, and dyspnea. Common grade 3 to grade 4 laboratory abnormalities included ⁢decreases in lymphocytes, neutrophils, hemoglobin, and white ⁢blood cell count.

Cytokine release syndrome developed in 46% of patients (grade 3, less than 1%), and 54% developed neurologic toxicity, including immune effector cell-associated neurotoxicity (ICANS; grades 3-4, 8%).

Linvoseltamab-gcpt⁢ carries a ⁢boxed warning for life-threatening cytokine release syndrome⁣ and neurologic toxicity, including ICANS. It is available only through the ⁢Lynozyfic Risk Evaluation and Mitigation Strategy program.

The FDA recommends administering linvoseltamab-gcpt through⁢ step-up IV doses starting at 5 mg, 25 ‍mg, and 200 mg, followed ⁢by ‍200 mg weekly for 10 doses, then 200 mg ⁢biweekly.⁢ The dosage can be decreased to 200 mg every 4 weeks if patients maintain a very good partial response‍ or better after week 24 and⁣ have received at least 17 doses ⁣at 200 mg.

What’s next

Further studies may explore ⁢linvoseltamab’s efficacy in earlier lines of⁤ multiple myeloma ⁣treatment.