FDA approves tafasitamab-cxix for relapsed or refractory follicular lymphoma
Regulatory approval: On June 18, 2025, the FDA approved tafasitamab-cxix (Monjuvi; Incyte) in combination with lenalidomide and rituximab for adults with relapsed or refractory follicular lymphoma. Approval was supported by the phase 3 inMIND trial (NCT04680052), which showed a statistically significant improvement in investigator-assessed progression-free survival versus placebo plus lenalidomide and rituximab (HR 0.43; p<0.0001).
FDA approval (June 18, 2025)
The FDA approved tafasitamab-cxix (Monjuvi, Incyte Corporation) with lenalidomide and rituximab for adults with relapsed or refractory follicular lymphoma (FL).
Supporting evidence: inMIND (NCT04680052)
Approval was based on inMIND, a double-blind, placebo-controlled trial that randomized 548 patients with relapsed or refractory FL to tafasitamab-cxix or placebo, each with lenalidomide and rituximab. Patients had received a median of 1 prior systemic therapy line; 25% had 2 prior lines and 20% had ≥3.
- Primary efficacy endpoint: investigator-assessed progression-free survival (PFS)
- Results (median follow-up 14.1 months): PFS was statistically significantly longer with tafasitamab-cxix (HR 0.43; 95% CI 0.32–0.58; p<0.0001). Estimated median PFS was 22.4 months (95% CI 19.2, not evaluable) vs 13.9 months (95% CI 11.5–16.4) in control.
Safety and dosing highlights
Serious adverse reactions occurred in 33% (serious infections 24%). Label warnings/precautions include infusion-related reactions, myelosuppression, and infections. Recommended dose: 12 mg/kg IV for a maximum of 12 cycles with lenalidomide and rituximab.
Regulatory notes
Review used Project Orbis (with TGA and Health Canada; other reviews ongoing), priority review, and orphan drug designation for FL. Tafasitamab-cxix is neither indicated nor recommended for relapsed/refractory marginal zone lymphoma outside controlled clinical trials.