On June 18, 2025, the FDA approved tafasitamab-cxix (Monjuvi; Incyte) with lenalidomide and rituximab for adults with relapsed or refractory follicular lymphoma (FL).1
The researchers evaluated the therapy in inMIND, a double-blind, placebo-controlled trial (NCT04680052) in which 548 patients with relapsed or refractory FL randomly received tafasitamab-cxix or placebo with lenalidomide and rituximab. Patients had received a median of 1 prior line of systemic therapy; 25% and 20% had 2 and 3 or more prior lines, respectively.
After a median follow-up of 14.1 months, progression-free survival (PFS) was statistically significantly longer in the tafasitamab-cxix arm.
After a median follow-up of 14.1 months, progression-free survival (PFS) was statistically significantly longer in the tafasitamab-cxix arm. The estimated median PFS was 22.4 months in the tafasitamab-cxix arm and 13.9 months in the control arm.
Serious adverse reactions occurred in 33% of patients in the tafasitamab-cxix arm, including serious infections in 24%. The prescribing information for tafasitamab-cxix includes warnings and precautions for infusion-related reactions, myelosuppression, and infections.
Reference
- FDA. FDA approves tafasitamab-cxix for relapsed or refractory follicular lymphoma [press release]. June 18, 2025. Accessed July 1, 2025. www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-tafasitamab-cxix-relapsed-or-refractory-follicular-lymphoma