FDA Approves Linvoseltamab-gcpt for Patients With Relapsed/Refractory Multiple Myeloma
On July 2, 2025, the US Food and Drug Administration (FDA) approved linvoseltamab-gcpt for the treatment of adults with relapsed/refractory (R/R) multiple myeloma (MM). This approval was based on results from the LINKER-MM1 trial.
The open-label, multi-cohort LINKER-MM1 trial enrolled 80 patients with R/R MM who previously received at least 3 prior lines of therapy with a proteasome inhibitor (PI), an immunomodulatory agent (IMiD), or an anti-CD38 monoclonal antibody.
Patients were treated with linvoseltamab (200 mg) weekly for 10 weeks, then 200 mg biweekly. The primary end points were safety and efficacy of linvoseltamab-gcpt, including objective response rate (ORR) with secondary end points including duration of response (DOR).
At a median follow-up of 11.3 months, the ORR was 70% (95% confidence interval [CI], 59 to 80). At 9 months, the median DOR was 89% (95% CI, 77 to 95) and at 12 months it was 72% (95% CI, 54 to 84).
In terms of safety, cytokine release syndrome (CRS) occurred in 46% of patients, of which 1% were grade 3, and neurologic toxicities including immune effector cell-associated neurotoxicity syndrome (ICANS) which occurred in 54% of patients, of those incidents, 8% were grade 3.
The recommended administration of linvoseltamab-gcpt is step-up doses of 5 mg, 25 mg, and 200 mg weekly for 10 doses followed by 200 mg biweekly. Dosing frequency may be decreased to every 4 weeks among patients who achieve a partial response or better at 24 weeks with at least 17 doses of linvoseltamab-gcpt (200 mg).
Source:
FDA grants accelerated approval to linvoseltamab-gcpt for relapsed or refractory multiple myeloma. Accessed on July 2, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-linvoseltamab-gcpt-relapsed-or-refractory-multiple-myeloma
