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.
Expedited Programs
This review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence. Project Orbis provides a framework for concurrent submission and review of oncology drugs among international partners. For this review, FDA collaborated with the Australian Therapeutic Goods Administration (TGA) and Health Canada. The application reviews are ongoing at the other regulatory agencies.
This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment.
This application was granted priority review. Tafasitamab-cxix received orphan drug designation for FL. FDA expedited programs are described in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics.
Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.
For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE’s Project Facilitate at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov.
Follow the Oncology Center of Excellence on X: @FDAOncology.
