USFDA Approves Linvoseltamab-Gcpt for Refractory Multiple Myeloma

The US FDA has approved linvoseltamab-gcpt, a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, for adults 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. It is the first FDA-approved BCMAxCD3 bispecific antibody. Clinical evidence In a clinical trial involving 80 patients with relapsed or refractory multiple myeloma, linvoseltamab-gcpt achieved an overall response rate (ORR) of 70%.

At 9 months, 89% of patients maintained a duration of response (DOR), and 72% maintained a DOR at 12 months. Dosage and administration Available only as an intravenous infusion Step-up dosing schedule: Day 1 – 5 mg; Day 2 – 25 mg; Day 15 – 200 mg Weekly dosing schedule: After day 15 and until week 13 – 200 mg Biweekly dosing schedule:…