Regeneron Treatment for Multiple Myeloma Gets Conditional Marketing Approval from EC

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The European Commission (EC) has granted conditional marketing approval to Regeneron Pharmaceuticals’ Lynozyfic (linvoseltamab) for treatment of adults with relapsed and refractory (R/R) multiple myeloma (MM), Regeneron announced on April 28, 2025 (1).

The indication for which linvoseltamab was conditionally approved is specifically for those patients who have received at least three prior therapies, including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy (1).

Regeneron’s linvoseltamab treatment is a bispecific antibody that is designed to bridge B-cell maturation antigen (BCMA) on MM cells with CD3-expressing T cells, resulting in the activation of T cells and killing of cancer cells, according to the company (1).

The decision by the EC comes two months after the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) recommended the treatment for authorization on Feb. 28, 2025 (2).

In the United States, a resubmission of the biologics license application for linvoseltamab was also accepted for review by FDA in February 2025, with a target action date of July 10, 2025 for FDA’s decision (1,3).

“Despite treatment advances, patients with multiple myeloma inevitably endure relapses, reduced responses to subsequent therapies, and increasingly shorter remissions. For those who develop relapsed and refractory disease after having been exposed to the three major drug classes, it’s important to have new therapies with different mechanisms of action like linvoseltamab,” Paula Rodriguez-Otero, MD, Department of Hematology, Cancer Center Clínica Universidad de Navarra, Pamplona, Navarra, Spain, said in Regeneron’s April 28 press release (1). “In a clinical trial, linvoseltamab demonstrated compelling and impressive efficacy with the potential for complete remission in this patient population, including those with high disease burden. Furthermore, its response-adapted schedule will provide patients a convenient treatment option.”

Regeneron said that Lynozyfic will be the first BCMA×CD3 therapy approved to be dosed every four weeks, due to a response-adapted regimen, if a very good partial response (or better) is observed after the completion of a minimum of 24 weeks of therapy (1).

“Lynozyfic is our second approved bispecific antibody—in this case for relapsed/refractory multiple myeloma patients—reinforcing our relentless commitment to transforming cancer care for those who need it most,” said George D. Yancopoulos, MD, PhD, board co-chair, president and chief scientific officer of Regeneron, in the release (1). “We are excited by the potential of Lynozyfic and its differentiated clinical profile, dosing, and administration. Given the strength of the data, we are pursuing a robust clinical development program exploring its use—in earlier lines of therapy as monotherapy and in novel combinations—with the hope of further advancing care for patients.”

The second-most common blood cancer, multiple myeloma is newly diagnosed in approximately 35,000 patients in Europe, and 187,000 globally, on an annual basis, according to Regeneron (1).

References

1. Regeneron. Lynozyfic (linvoseltamab) Approved in the European Union for the Treatment of Relapsed/Refractory Multiple Myeloma. Press Release. April 28, 2025.
2. Regeneron. Linvoseltamab Recommended for EU Approval by the CHMP to Treat Relapsed/Refractory Multiple Myeloma. Press Release. Feb. 28, 2025.
3. Regeneron. Linvoseltamab BLA Accepted for FDA Review for the Treatment of Relapsed/Refractory Multiple Myeloma. Press Release. Feb. 11, 2025.