FDA

Lynozyfic gains accelerated approval for multiple myeloma

July 7, 2025

Brand name: Lynozyfic

Generic name: linvoseltamab-gcpt

Manufacturer: Regeneron Pharmaceuticals, Inc.

Approval date: July 2, 2025

FDA granted accelerated approval to Lynozyfic (linvoseltamab-gcpt), a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, for adults with relapsed or refractory multiple myeloma who’ve received ≥4 prior lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory agent (IMiD), and an anti-CD38 monoclonal antibody.

Efficacy

Approval was based on data from LINKER-MM1 (NCT03761108), an open-label, multi-center multi-cohort trial that included patients who’d previously received ≥3 prior therapies, including a PI, an IMiD, and an anti-CD38 antibody. The trial excluded patients with prior BCMA-directed bispecific antibody therapy, prior bispecific T-cell engaging therapy, or prior BCMA CAR-T cell therapy. The efficacy population included 80 patients who’d received ≥4 prior lines of therapy, including a PI, an IMiD, and an anti-CD38 monoclonal antibody.

Efficacy was based on objective response rate (ORR) determined by a blinded independent review committee using International Myeloma Working Group criteria. ORR was 70% (95% confidence interval [CI], 59-80). With a median follow-up of 11.3 months among responders, the estimated duration of response (DOR) was 89% (95% CI, 77-95) at 9 months and 72% (95% CI, 54-84) at 12 months.

Safety

The most common adverse reactions (≥20%) in the trial were musculoskeletal pain, cytokine release syndrome (CRS), cough, upper respiratory tract infection, diarrhea, fatigue, pneumonia, nausea, headache, and dyspnea. The most common Grade 3 or 4 laboratory abnormalities (≥30%) were decreased lymphocyte count, decreased neutrophil count, decreased hemoglobin, and decreased white blood cell count.

The prescribing information includes a Boxed Warning for life- threatening CRS and neurologic toxicity, including immune effector cell-associated neurotoxicity (ICANS). Among patients who received linvoseltamab-gcpt in the LINKER-MM1 trial at the recommended dose, CRS occurred in 46% and neurologic toxicity including ICANS in 54% of patients. Grade 3 CRS occurred in <1% of patients and Grade 3 or 4 neurologic toxicity occurred in 8%.

Because of the risks of CRS and neurologic toxicity, including ICANS, Lynozyfic is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Other warnings and precautions include infections, neutropenia, hepatotoxicity, and embryo-fetal toxicity.

Recommended dose

The recommended administration of IV Lynozyfic includes step-up doses of 5 mg, 25 mg, and 200 mg, followed by 200 mg weekly for 10 doses, followed by 200 mg q2wks. In patients who’ve achieved and maintained a very good partial response or better at or after week 24 and received at least 17 doses of 200 mg, the dosing frequency is decreased to 200 mg q4wks.

Sources:

FDA grants accelerated approval to linvoseltamab-gcpt for relapsed or refractory multiple myeloma. [News release]. 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-linvoseltamab-gcpt-relapsed-or-refractory-multiple-myeloma

Lynozyfic™ (linvoseltamab-gcpt) receives FDA accelerated approval for treatment of relapsed or refractory multiple myeloma. [News release]. 2025. https://newsroom.regeneron.com/news-releases/news-release-details/lynozyfictm-linvoseltamab-gcpt-receives-fda-accelerated-approval

Lynozyfic (linvoseltamab-gcpt) [package insert]. Regeneron. https://www.regeneron.com/downloads/lynozyfic_fpi.pdf Revised July 2025. Accessed July 3, 2025.