The US Food and Drug Administration has granted accelerated approval to linvoseltamab (Lynozyfic) in adults patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti‑CD38 monoclonal antibody.
The accelerated approval is based on data from the pivotal phase 1/2 LINKER-MM1 trial. In the trial, patients receiving the bispecific antibody were shown to have an objective response rate of 70% with 45% of patients achieving a complete response or better.
“The FDA approval of Lynozyfic represents meaningful progress for the multiple myeloma community. Lynozyfic demonstrated early, deep and durable responses in heavily pre-treated patients, which I saw firsthand in clinical trials,” said Sundar Jagannath, MD, the Network Director of the Center of Excellence for Multiple Myeloma at Mount Sinai in New York City and a trial investigator. “Lynozyfic has a convenient response-adapted dosing regimen, which provides the potential to extend time between doses. This is a significant patient-centric advancement that could help reduce treatment burden.”
