By Patrick Daly - Last Updated: February 7, 2024
The Marketing Authorization Application for linvoseltamab has been submitted and is under review by the European Medicines Agency (EMA), and a Biologics License Application was submitted to the US Food and Drug Administration, according to a release from Regeneron Pharmaceuticals, the manufacturer of the drug.
Linvoseltamab is a bispecific antibody against BCMA developed to treat adult patients with relapsed or refractory multiple myeloma (MM) who progressed after at least three lines of therapy.
The linvoseltamab application includes data from the ongoing, pivotal phase I/II LINKER-MM1 trial. The primary endpoint is objective response rate and secondary endpoints include duration of response, progression-free survival, measurable residual disease negativity, and overall survival.
The trial has enrolled 282 patients who all received an initial step-up dosing regimen followed by a full dose. Patients who achieved a very good partial response or complete response could swap from linvoseltamab every two weeks to every four weeks after at least 24 weeks of treatment.
The follow-up phase III LINKER-MM3 trial is currently enrolling, and additional planned or ongoing trials include linvoseltamab in first-line therapy, high-risk smoldering MM, monoclonal gammopathy of undetermined significance, and in combination with a CD32xCD28 bispecific.
Original Source: Application for Linvoseltamab in Multiple Myeloma Accepted for Review in Europe | Blood Cancers Today