In a significant advancement for lymphoma treatment, the FDA has approved Monjuvi (tafasitamab-cxix) in combination with lenalidomide and rituximab for adults with relapsed or refractory follicular lymphoma (FL). This new triple regimen offers a promising option for patients who have previously undergone systemic therapy

The approval is based on data from the inMIND trial (NCT04680052), a randomized, double-blind, placebo-controlled study involving 548 patients. The combination demonstrated a significant improvement in progression-free survival (PFS). Median PFS was 22.4 months with tafasitamab-cxix versus 13.9 months with placebo (HR 0.43; p < 0.0001).

As for the dosage of Tafasitamab-cxix it is administered as a 12 mg/kg IV infusion, up to 12 cycles alongside lenalidomide and rituximab. It is not indicated for marginal zone lymphoma outside of clinical trials.

Serious adverse events were seen in 33% of patients, with infections stated in 24%. The product labeling includes warnings for infusion-related reactions, myelosuppression, and infections.

This approval was granted under the FDA’s Project Orbis and received priority review and orphan drug designation. International regulatory reviews are ongoing in collaboration with Australia's TGA and Health Canada

Learn more: FDA approves tafasitamab-cxix for relapsed or refractory follicular lymphoma | FDA