After issues at a third-party manufacturer caused the FDA to reject Regeneron's multiple myeloma bispecific antibody linvoseltamab, the company has crossed the regulatory finish line with its new drug in Europe.

The European Commission has approved Regeneron's Lynozyfic as a treatment for patients with relapsed or refractory multiple myeloma who have received three or more prior therapies, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody.

Branded as Lynozyfic, the drug is designed to bridge B-cell maturation antigen (BCMA) on multiple myeloma cells with CD3-expressing T cells to trigger T-cell activation. Under a response-adapted regimen, the drug can be given every four weeks if patients achieve a "very good partial response" or better after 24 weeks of therapy, Regeneron said in an April 28 press release.

For patients with multiple myeloma who have relapsed while on multiple other treatment classes, it's "important to have new therapies with different mechanisms of action," Paula Rodriguez-Otero, M.D., of Spain's Cancer Center Clínica Universidad de Navarra, said in a statement. 

In a clinical trial, Regeneron's new drug "demonstrated compelling and impressive efficacy with the potential for complete remission" in this patient group, Rodriguez-Otero continued.

Specifically, the LINKER-MM1 trial showed that 71% of patients with relapsed or refractory multiple myeloma had a complete or partial response. The median duration of response was 29 months. The trial's complete response rate was 50%. 

A range of adverse reactions were documented in the study, including musculoskeletal pain experienced by 52% of treated patients, cytokine release syndrome (CRS) experienced by 46%, and diarrhea experienced by 39%. In addition, investigators recorded a 38% adverse reaction rate for anemia, 36% for fatigue, 32% for pneumonia and 30% for upper respiratory tract infection.

There was one case of grade 3 CRS and no cases of grade 4 or above CRS, Regeneron said.

The EU approval comes after the FDA turned away Regeneron's linvoseltamab filing last summer. At the time, Regeneron said that the "sole approvability issue identified" involved the agency's inspection of a third-party manufacturer's facility for another approval filing.

Regeneron has since re-filed the BCMAxCD3 drug in the U.S., and it's now awaiting a July 10 decision target date.

With linvoseltamab's delayed arrival in the U.S., the multiple myeloma bispecific antibody market has had more time to evolve. Johnson & Johnson's Tecvayli, an in-class rival, scored its FDA approval in 2022 and generated full-year sales of $549 million in 2024. Pfizer's Elrexfio entered the market in 2023 and pulled down $133 million last year. Both drugs are approved in Europe as well.

For patients with multiple myeloma who have relapsed while on multiple other treatment classes, it's "important to have new therapies with different mechanisms of action," Paula Rodriguez-Otero, M.D., of Spain's Cancer Center Clínica Universidad de Navarra, said in a statement. 

In a clinical trial, Regeneron's new drug "demonstrated compelling and impressive efficacy with the potential for complete remission" in this patient group, Rodriguez-Otero continued.

Specifically, the LINKER-MM1 trial showed that 71% of patients with relapsed or refractory multiple myeloma had a complete or partial response. The median duration of response was 29 months. The trial's complete response rate was 50%. 

A range of adverse reactions were documented in the study, including musculoskeletal pain experienced by 52% of treated patients, cytokine release syndrome (CRS) experienced by 46%, and diarrhea experienced by 39%. In addition, investigators recorded a 38% adverse reaction rate for anemia, 36% for fatigue, 32% for pneumonia and 30% for upper respiratory tract infection.

There was one case of grade 3 CRS and no cases of grade 4 or above CRS, Regeneron said.

The EU approval comes after the FDA turned away Regeneron's linvoseltamab filing last summer. At the time, Regeneron said that the "sole approvability issue identified" involved the agency's inspection of a third-party manufacturer's facility for another approval filing.

Regeneron has since re-filed the BCMAxCD3 drug in the U.S., and it's now awaiting a July 10 decision target date.

With linvoseltamab's delayed arrival in the U.S., the multiple myeloma bispecific antibody market has had more time to evolve. Johnson & Johnson's Tecvayli, an in-class rival, scored its FDA approval in 2022 and generated full-year sales of $549 million in 2024. Pfizer's Elrexfio entered the market in 2023 and pulled down $133 million last year. Both drugs are approved in Europe as well.