Tafasitamab-cxix Approved for Relapsed or Refractory Follicular Lymphoma
Expert Perspectives · Lyn Brook · 2025-06-23
The FDA has granted approval to tafasitamab-cxix (Monjuvi®, Incyte Corporation) in combination with lenalidomide and rituximab for the treatment of adults with relapsed or refractory follicular lymphoma (FL). This approval is for patients who have experienced disease progression following at least one prior line of systemic therapy.
Tafasitamab-cxix is not indicated for patients with relapsed or refractory marginal zone lymphoma outside of controlled clinical trials.
Why This Approval Matters
The approval of tafasitamab-cxix in combination with lenalidomide and rituximab provides a new, evidence-based treatment option for patients with relapsed or refractory FL. This regimen offers a statistically significant improvement in progression-free survival (PFS), addressing an important unmet need for patients whose disease has returned or not responded to previous therapies.
Breaking Down the inMIND Trial
The efficacy of tafasitamab-cxix was evaluated in the inMIND trial (NCT04680052), a double-blind, placebo-controlled study. The trial enrolled 548 patients with relapsed or refractory FL who had received a median of one prior line of systemic therapy; 25% had received two prior lines, and 20% had received three or more. Patients were randomized to receive either tafasitamab-cxix or placebo, each in combination with lenalidomide and rituximab.
The primary efficacy end point was investigator-assessed PFS. At a median follow-up of 14.1 months, tafasitamab-cxix produced a statistically significant increase in duration of PFS compared with the control arm. The estimated median PFS was 22.4 months in the tafasitamab-cxix arm versus 13.9 months in the control arm.
Managing Adverse Events
Serious adverse reactions occurred in 33% of patients receiving tafasitamab-cxix, including serious infections in 24%. The safety profile observed was consistent with known risks of the regimen. The prescribing information for tafasitamab-cxix includes warnings and precautions for infusion-related reactions, myelosuppression, and infections.
Clinical Implications and Future Outlook
“Addition of tafasitamab-cxix to lenalidomide and rituximab resulted in significant and clinically meaningful improvement in PFS, representing a 57% reduction in risk of progression, relapse, or death in patient with relapsed/refractory FL,” concluded Laurie Sehn, MD, MPH, a Clinical Professor with the BC Cancer Centre for Lymphoid Cancer and University of British Columbia, and colleagues, in their published results of the inMIND trial. “Tafasitamab-cxix plus lenalidomide and rituximab can be administered in community as well as academic settings and represents a potential new standard of care option for patients with relapsed/refractory FL.”
Dosing and Administration
The recommended dose of tafasitamab-cxix is 12 mg/kg administered as an intravenous infusion for a maximum of 12 cycles, in combination with lenalidomide and rituximab. Treatment should continue until disease progression or unacceptable toxicity.