Regeneron Pharmaceuticals gained priority review from FDA for linvoseltamab to treat adult patients with R/R Multiple Myeloma that has progressed after ≥3 prior therapies

In February 2024, following positive results from a phase 1/2 study (LINKER-MM1), the FDA accepted a BLA from Regeneron Pharmaceuticals, Inc (Regeneron), for linvoseltamab to treat adult patients with RRMM that has progressed after ≥3 prior therapies and granted it priority review.

Linvoseltamab is an investigational bispecific antibody designed to bridge B-cell maturation antigen on MM cells with CD3-expressing T cells to facilitate T-cell activation and the killing of cancer cells, according to the sponsor.

Regeneron is also recruiting ~300 participants for an open-label, randomized phase 3 study (LINKER-MM3) evaluating the efficacy and safety of linvoseltamab compared to the combination of elotuzumab, pomalidomide, and dexamethasone in participants with RRMM who have returned after having received prior treatment that included lenalidomide, a proteasome inhibitor, and a CD38 mAb. The primary outcome measure is PFS per IMWG response criteria determined by IRC in CD38-exposed participants up to ~5 years. The study began in September 2023 and is expected to complete in December 2032.