Regeneron Pharmaceuticals announced on 2 July that US regulator the Food and Drug Administration (FDA) granted accelerated approval to Lynozyfic (linvoseltamab), a BCMAxCD3 bispecific antibody (BsAb), for adults with relapsed/refractory multiple myeloma (r/r MM) who received ≥4 prior therapies. The approval was based on Phase I/II LINKER-MM1 trial data showing a 70% objective response rate (ORR) and 45% complete response rate (CRR) among heavily pretreated patients (n=80). Lynozyfic features a response-adapted dosing regimen, allowing reduced frequency from weekly to every four weeks for responders maintaining very good partial response (VGPR) or better after 24 weeks.

The therapy carries a boxed warning for cytokine release syndrome (CRS) and neurologic toxicity. Common adverse events included musculoskeletal pain (54%), CRS (48%) and infections (36%). Regeneron plans confirmatory Phase III trials (LINKER-MM3) while exploring earlier-line use and combinations. MM, the second most common blood cancer, affects over 187,000 patients globally every year. Lynozyfic becomes the first FDA-approved BCMAxCD3 bispecific with flexible dosing.

Source:
https://www.globenewswire.com/news-release/2025/07/02/3109328/0/en/Lynozyfic-linvoseltamab-gcpt-Receives-FDA-Accelerated-Approval-for-Treatment-of-Relapsed-or-Refractory-Multiple-Myeloma.html