FDA Grants Approval to Tafasitamab for Patients With Relapsed/Refractory Follicular Lymphoma
On June 18, 2025, the US Food and Drug Administration (FDA) approved tafasitamab with lenalidomide and rituximab for the treatment of adults with relapsed/refractory (R/R) follicular lymphoma (FL). This approval was based on results from the inMIND trial.
The double-blind, placebo controlled inMIND trial enrolled 548 patients with R/R FL who were randomized to receive tafasitamab-cxix (12 mg/kg) or placebo in addition to lenalidomide and rituximab for a maximum of 12 28-day cycles. The primary end point was investigator-assessed progression-free survival (PFS) after 174 observed events.
At a median follow-up of 14.1 months, the PFS was longer among patients treated with tafasitamab-cxix compared to placebo (22.4 months; 95% confidence interval [CI], 19.2 to not evaluable vs 13.9 months; 95% CI, 11.5 to 16.4; hazard ratio [HR], 0.43; 95% CI, .32 to .58).
In terms of safety, serious adverse events occurred more often in the tafasitamab-cxix arm than placebo (33% vs 24%). The most common adverse events included neutropenia, pneumonia, thrombocytopenia, decreased neutrophils, COVID-19 infection, and COVID-19 pneumonia. Reports of death during treatment were higher in the placebo arm than the tafasitamab-cxix arm (8.5% vs 5.5%), including fatal adverse events among 6 patients in both arms.
Source:
FDA approves tafasitamab-cxix for relapsed or refractory follicular lymphoma. US Food and Drug Administration. Accessed June 18, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-tafasitamab-cxix-relapsed-or-refractory-follicular-lymphoma
