Multiple Myeloma Treatment from Regeneron Gets FDA Accelerated Approval

Regeneron Pharmaceuticals announced on July 2, 2025, that FDA has granted accelerated approval for linvoseltamab-gcpt, marketed by Regeneron as Lynozyfic, for treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy—including among those a proteasome inhibitor, immunomodulatory agent, and anti-CD38 protein monoclonal antibody (1).

Firsts for FDA multiple myeloma approvals

In a press release, Regeneron said the treatment is the first of its kind approved by FDA to treat multiple myeloma: a bispecific antibody engineered to bridge B-cell maturation antigen (BCMA) on multiple myeloma cells with CD3 protein-expressing T cells (1). This design, according to the company, facilitates T cell activation and cancer cell killing.

FDA’s approval, according to the press release, was based on the rate and durability of response observed in a Phase I/II trial (LINKER-MM1), with continued approval contingent upon the verification and description of the treatment’s clinical benefits in a confirmatory trial (1). After an initial step-up dosing regimen followed by a full dose administered weekly, linvoseltamab-gcpt can be dosed every two weeks starting at week 14 and every four weeks if there is a very good partial response, or better, after the completion of 24 weeks of therapy, marking another first in an FDA approval for a multiple myeloma treatment.

“The FDA approval of Lynozyfic reinforces the strength of our bispecific antibody program as well as our commitment to delivering critical medicines to the cancer community,” George D. Yancopoulos, MD, PhD, board co-chair, president and chief scientific officer of Regeneron, said in the release (1). “With a 70% overall response rate in heavily pre-treated patients, we believe Lynozyfic is poised to potentially become a new standard of care for multiple myeloma. Furthermore, given the strength of the data, we are rapidly advancing our broad clinical development program for Lynozyfic—exploring its use in earlier lines of therapy as monotherapy and in novel combinations—as we aim to meaningfully advance care for patients.”

Treatment moving forward in Europe

Regeneron has also advanced linvoseltamab under the Lynozyfic brand name in Europe. A conditional marketing authorization granted by the European Medicines Agency’s Committee for Medicinal Products for Human Use on Feb. 28, 2025 was followed by conditional approval from the European Commission two months later to the date, April 28, 2025 (2,3). The treatment received the same basic indication in Europe as in the United States: for adult patients who had received the therapies detailed above, and who demonstrated disease progression on the last of those therapies.

In the US, Regeneron said, more than 36,000 diagnoses and 12,000 deaths from multiple myeloma are projected in 2025, among an average of more than 187,000 cases diagnosed annually worldwide (1). Approximately 8000 US patients are living with multiple myeloma that has progressed after three lines of therapy, 4000 of those whose disease has progressed following four or more therapies. Despite advancements in treatment that slow progression of the cancer, it remains incurable at the present time.

References

1. Regeneron. Lynozyfic (linvoseltamab-gcpt) Receives FDA Accelerated Approval for Treatment of Relapsed or Refractory Multiple Myeloma. Press Release. July 2, 2025.
2. Regeneron. Linvoseltamab Recommended for EU Approval by the CHMP to Treat Relapsed/Refractory Multiple Myeloma. Press Release. Feb. 28, 2025.
3. Regeneron. Lynozyfic (linvoseltamab) Approved in the European Union for the Treatment of Relapsed/Refractory Multiple Myeloma. Press Release. April 28, 2025.