FDA

Monjuvi approved for follicular lymphoma

June 25, 2025

FDA approved Monjuvi (tafasitamab-cxix) with lenalidomide and rituximab for adults with relapsed or refractory follicular lymphoma (FL).

Monjuvi was previously approved in combination with lenalidomide for the treatment of relapsed or refractory large B-cell lymphoma.

Efficacy

Approval was based on results from the phase 3 double-blind, placebo-controlled inMIND trial (NCT04680052) involving 548 patients with relapsed or refractory FL who received either 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% confidence interval [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 arm.

Note: The inMIND trial also included an evaluation of Monjuvi in 106 patients with relapsed or refractory marginal zone lymphoma (MZL). Since no evidence of improvement in PFS was seen in this cohort, Monjuvi is thus neither indicated nor recommended for relapsed or refractory MZL patients outside of controlled clinical trials.

Safety

The most common adverse reactions (≥ 20%), excluding lab abnormalities, in patients with relapsed or refractory FL were respiratory tract infections, diarrhea, rash, fatigue, constipation, musculoskeletal pain, and cough. The most common Grade 3 or 4 lab abnormalities (≥ 20%) were decreased neutrophils and decreased lymphocytes.

Recommended dose

The recommended dosage of tafasitamab-cxix dose is 12 mg/kg as an IV infusion for a maximum of 12 cycles with lenalidomide and rituximab.

Sources:

FDA approves tafasitamab-cxix for relapsed or refractory follicular lymphoma. [News release]. 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-tafasitamab-cxix-relapsed-or-refractory-follicular-lymphoma

Monjuvi (tafasitamab-cxix) [package insert]. Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761163s013lbl.pdf Revised June 2025. Accessed June 23, 2025.