FDA Approves Linvoseltamab to Treat R/R Multiple Myeloma
This approval comes almost a year after the drug received a complete response letter due to third-party manufacturing issues.
Linvoseltamab (Regeneron) has been
The approval marks a critical step forward for patients with late-stage MM, many of whom face limited treatment options and progressive disease.
"Lynozyfic demonstrated early, deep and durable responses in heavily pre-treated patients, which I saw firsthand in clinical trials,” Sundar Jagannath, MD, trial investigator and network director of the Center of Excellence for Multiple Myeloma at Mount Sinai, said in a
Patients Reach 70% ORR With Linvoseltamab
Linvoseltamab is a bispecific antibody designed to activate T cells by binding to B-cell maturation antigen (BCMA) on MM cells and CD3 on T cells, enabling immune-mediated tumor destruction. According to an FDA news release, the approval was based on results from the ongoing phase 1/2 LINKER-MM1 trial (
Previous reports showed that, at a median follow-up of
Mansi Shah, MD, assistant professor at Rutgers Cancer Institute of New Jersey,
Despite the high response rates, safety remains a consideration in clinical use. Cytokine release syndrome (CRS) occurred in 46% of patients in the LINKER-MM1 trial. However, most cases were mild and resolved quickly within a median of 14.7 hours, supporting a favorable safety profile compared with other bispecific antibodies, according to Shah. She also said reduced dosing frequency after initial treatment led to a notable decline in infection rates over time.
Linvoseltamab is administered weekly at its full dose following an initial step-up schedule, with dosing reduced to every 2 weeks after week 16; for patients who achieve a very good partial response or better after 24 weeks, dosing is reduced to every 4 weeks.1
Already Approved in Europe
Fill/finish manufacturing deficiencies at a third-party facility had previously resulted in a
Europe was a step ahead of the US, with the
References
- Lynozyfic (linvoseltamab-gcpt) receives FDA accelerated approval for treatment of relapsed or refractory multiple myeloma. Regeneron. News release. July 2, 2025. Accessed July 2, 2025.
https://investor.regeneron.com/news-releases/news-release-details/lynozyfictm-linvoseltamab-gcpt-receives-fda-accelerated-approval - Phase 1/2 study of REGN5458 in adult patients with relapsed or refractory multiple myeloma (LINKER-MM1). Clinicaltrials.gov. Updated May 15, 2025. Accessed June 20, 2025.
https://clinicaltrials.gov/study/NCT03761108 - Rosa K. Linvoseltamab elicits deep, durable responses in R/R multiple myeloma. OncLive®. June 17, 2024. Accessed June 20, 2025.
https://www.onclive.com/view/linvoseltamab-elicits-deep-durable-responses-in-r-r-multiple-myeloma - Steinzor P. Linvoseltamab shows durable efficacy, manageable safety in R/R multiple myeloma. AJMC®. December 10, 2024. Accessed June 20, 2025.
https://www.ajmc.com/view/linvoseltamab-shows-durable-efficacy-manageable-safety-in-r-r-multiple-myeloma - Klein HE. FDA issues CRL for linvoseltamab in R/R multiple myeloma. AJMC. August 21, 2024. Accessed June 20, 2025.
https://www.ajmc.com/view/fda-issues-crl-for-linvoseltamab-in-r-r-multiple-myeloma - Lynozyfic (linvoseltamab) approved in the European Union for the treatment of relapsed/refractory multiple myeloma. Regeneron. News release. April 28, 2025. Accessed June 20, 2025.
https://investor.regeneron.com/news-releases/news-release-details/lynozyfictm-linvoseltamab-approved-european-union-treatment
Articles in this issue
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Advances in Oncology: When Innovation and Challenge Intersectabout 1 month ago
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