FDA Approves Tafasitamab in R/R Follicular Lymphoma

US FDA

• Tafasitamab-cxix (Monjuvi) is now FDA-approved with lenalidomide (Revlimid) and rituximab (Rituxan) for adults with relapsed/refractory follicular lymphoma (R/R FL).
• The inMIND trial (NCT04680052) showed a 57% reduction in risk of progression or death, with median progression-free survival (PFS) of 22.4 months vs. 13.9 months in control.
• Serious infections occurred in 24% of patients; label includes warnings for infusion reactions, myelosuppression, and infection risk.

The FDA has approved tafasitamab in combination with lenalidomide and rituximab for the treatment of adult patients with R/R FL. This regulatory decision marks an important addition to the therapeutic landscape for patients with this indolent yet often relapsing form of non-Hodgkin lymphoma.

This approval was based on findings from the phase 3 inMIND trial, a randomized, double-blind, placebo-controlled study evaluating tafasitamab in combination with lenalidomide and rituximab vs placebo with the same backbone therapy. The trial enrolled 548 patients with R/R FL who had received at least 1 prior systemic therapy. The patient population was reflective of real-world relapsed disease: 25% had received 2 prior lines of treatment, and 20% had received 3 or more.

The primary end point of the trial was investigator-assessed PFS. With a median follow-up of 14.1 months, the study demonstrated a statistically significant improvement in PFS for the tafasitamab arm compared with the control arm. The hazard ratio for disease progression or death was 0.43 (95% CI, 0.32-0.58; P <.0001), representing a 57% reduction in risk. Median PFS was 22.4 months (95% CI, 19.2-not evaluable [NE]) in the tafasitamab group vs 13.9 months (95% CI, 11.5-16.4) in the control arm.

Lymphoma: © David A Litman - www.stock.adobe.com

According to independent review committee (IRC) assessment, the median PFS was not yet reached (NR; 95% CI, 19.3-NE) with the triplet compared with 16.0 months (95% CI, 13.9-21.1) with the doublet (HR, 0.41; 95% CI, 0.29-0.56; P <.0001).² These results were presented at the 2024 ASH Annual Meeting.

The safety profile of tafasitamab in this combination was consistent with known adverse events from prior studies involving CD19-targeted therapies. Serious adverse reactions occurred in 33% of patients receiving tafasitamab, with serious infections reported in 24%.¹

Key warnings and precautions in the product labeling include infusion-related reactions, myelosuppression, and infections. Clinicians are advised to monitor blood counts and infection risk during therapy and to manage infusion reactions with appropriate premedication and supportive care.

The recommended dosage of tafasitamab is 12 mg/kg administered via intravenous infusion. Treatment is intended for up to 12 cycles in combination with lenalidomide and rituximab. This regimen is not approved for use in relapsed/refractory marginal zone lymphoma and is not recommended for such patients outside of clinical trials.

Tafasitamab, a humanized monoclonal antibody targeting CD19, was previously approved for use in combination with lenalidomide for R/R diffuse large B-cell lymphoma. This new indication in follicular lymphoma represents a broadened role for tafasitamab in B-cell malignancies and offers a chemotherapy-free triplet option for patients with relapsed disease who may benefit from immune-based therapy.

REFERENCES:

1. FDA approves tafasitamab-cxix for relapsed or refractory follicular lymphoma. News release. US FDA. June 18, 2025. Accessed June 18, 2025. https://tinyurl.com/4a97zn26

2. Sehn LH, Luminari S, Scholz CW, et al. Tafasitamab plus lenalidomide and rituximab for relapsed or refractory follicular lymphoma: results from a phase 3 study (inMIND). Blood. 2024;144(suppl 2):LBA-1. doi:10.1182/blood-2024-212970