On June 18, 2025, the Food and Drug Administration approved tafasitamab-cxix (Monjuvi, Incyte Corporation) with lenalidomide and rituximab for adults with relapsed or refractory follicular lymphoma (FL).
Full prescribing information for Monjuvi will be posted on Drugs@FDA.
Efficacy and Safety
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.
Recommended Dosage
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.
Source from FDA
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