By Fineline Cube 
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced that it has received conditional marketing authorization from the European Commission (EC) for its bispecific antibody (BsAb) Lynozyfic (linvoseltamab). The therapy is approved for adult patients with relapsed and refractory multiple myeloma (R/R MM) who have received at least three prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody, and whose disease has progressed on the last treatment.
Therapeutic Innovation and Adaptive Regimen
Lynozyfic is the first BCMAxCD3 bispecific antibody approved in Europe with a response-adapted regimen. Patients achieving a very good partial response (VGPR) or better after completing at least 24 weeks of therapy may transition to dosing every four weeks. This adaptive dosing approach aims to optimize treatment efficacy and patient convenience.
Clinical Trial Data Supporting Approval
The approval is supported by data from the pivotal LINKER-MM1 trial (200 mg cohort, n=117). Key results include a 71% objective response rate (ORR) by independent review, with 50% of patients achieving a complete response (CR) or better. Additionally, a 41% minimal residual disease (MRD) negativity rate was observed among CR/stringent CR patients (24/58; 95% CI: 29–55%), and the median duration of response (DOR) was 29 months (95% CI: 19–NE). These results highlight Lynozyfic’s potential to significantly improve outcomes for patients with advanced multiple myeloma.-Fineline Info & Tech