FDA approves tafasitamab for relapsed or refractory follicular lymphoma in 2 line
On June 18, 2025, the Food and Drug Administration approved tafasitamab-cxix (Monjuvi, Incyte Corporation), a humanized Fc-modified cytolytic CD19-targeting monoclonal antibody, in combination with lenalidomide and rituximab for adults with relapsed or refractory follicular lymphoma (FL).
The recommended tafasitamab-cxix dose is 12 mg/kg as an intravenous infusion for a maximum of 12 cycles with lenalidomide and rituximab. Tafasitamab-cxix is neither indicated nor recommended for patients with relapsed or refractory marginal zone lymphoma outside of controlled clinical trials.
Efficacy was evaluated in inMIND, a double-blind, placebo-controlled trial (NCT04680052) randomizing 548 patients with relapsed or refractory FL to receive 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.
The major efficacy outcome measure was investigator-assessed progression-free survival (PFS). After a median follow-up of 14.1 months, PFS was statistically significantly longer in the tafasitamab-cxix arm (hazard ratio 0.43 [95% CI: 0.32, 0.58]; p-value <0.0001). The estimated median PFS was 22.4 months (95% CI: 19.2, not evaluable) in the tafasitamab-cxix arm and 13.9 months (95% CI: 11.5, 16.4) in the control.
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.
In July 2020, Monjuvi in combination with lenalidomide received FDA approval for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication was approved under accelerated approval by the U.S. FDA based on overall response rate (ORR). Continued approval of Monjuvi for this indication may be contingent on verification and description of clinical benefit in confirmatory trial(s). Tafasitamab is also being evaluated as a therapeutic option in an ongoing pivotal trial for first-line DLBCL.