FDA Approves Tafasitamab Combo in R/R Follicular Lymphoma

Fact checked by" Roman Fabbricatore
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Tafasitamab combined with lenalidomide and rituximab demonstrated a median OS of 22.4 months vs 13.9 months with placebo in patients with follicular lymphoma.

Data from the phase 3 InMIND trial (NCT04680052) supported the FDA approval of tafasitamab plus lenalidomide and rituximab for adult patients with relapsed/refractory follicular lymphoma.

Data from the phase 3 InMIND trial (NCT04680052) supported the FDA approval of tafasitamab plus lenalidomide and rituximab for adult patients with relapsed/refractory follicular lymphoma.

The FDA has approved tafasitamab-cxix (Monjuvi) in combination with lenalidomide (Revlimid) and rituximab (Rituxan) as a treatment for patients with relapsed or refractory follicular lymphoma, according to a release from the agency.1

Supporting results from the double-blind, placebo-controlled phase 3 inMIND trial (NCT04680052) compared the approved combination vs placebo with lenalidomide and rituximab. A total of 548 patients with relapsed or refractory follicular lymphoma were randomly assigned to receive one of the combinations.

With a median follow-up of 14.1 months, the median progression-free survival (PFS) was 22.4 months with tafasitamab (95% CI, 19.2-not evaluable) vs 13.9 months (95% CI, 11.5-16.4) in the control arm, demonstrating a statistically significant improvement (HR, 0.43; 95% CI, 0.32-0.58; P <.0001).

The median number of prior lines of therapy was 1, with 25% receiving 2 lines and 20% receiving 3 or more lines.

The recommended dosage of tafasitamab is 12 mg/kg via intravenous infusion for a maximum of 12 cycles with lenalidomide and rituximab. It was noted that the agent is neither indicated nor recommended for the treatment of relapsed or refractory marginal zone lymphoma outside of controlled clinical trials.

Regarding safety, serious adverse reactions were observed in 33% of patients who received tafasitamab, 24% of which were serious infections. Warnings for infusion-related reactions, myelosuppression, and infections appear on the prescribing information for tafasitamab.

Previously, results from the phase 3 inMIND trial were exhibited at the 2024 American Society of Hematology Annual Meeting and Exposition.2

References

  1. FDA approves tafasitamab-cxix for relapsed or refractory follicular lymphoma. FDA. June 18, 2025. Accessed June 18, 2025. https://tinyurl.com/njjw9rpu
  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
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