Incyte has received the US Food and Drug Administration (FDA) approval for Monjuvi (tafasitamab-cxix) in combination with rituximab and lenalidomide for adult patients with relapsed or refractory follicular lymphoma (FL).

Monjuvi, a humanised Fc-modified cytolytic CD19-targeting monoclonal antibody, is engineered to facilitate B-cell lysis through several mechanisms.

The mechanisms include Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP).

Monjuvi was previously approved in the US in July 2020 for use in combination with lenalidomide for relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

The earlier approval was based on the overall response rate (ORR) and was granted under accelerated approval.

Incyte CEO Hervé Hoppenot said: “Patients living with relapsed or refractory FL have been waiting for new options that improve progression-free survival without a substantial increase in side effects.

“Based on the data from the inMIND trial of Monjuvi, today’s approval brings to this patient population the first CD-19 and CD20-targeted immunotherapy combination and a potential new treatment standard.

“This second US approval for Monjuvi reinforces our commitment to advancing innovation for the lymphoma community.”

The FDA approval follows a successful Phase 3 inMIND trial and represents a significant development in the treatment options for FL.

The inMIND trial was a randomised, double-blind, placebo-controlled study evaluating the efficacy and safety of Monjuvi combined with rituximab and lenalidomide.

The study has met its primary endpoint, showing a statistically significant improvement in progression-free survival (PFS).

In the study, patients receiving Monjuvi experienced a median PFS of 22.4 months, compared to 13.9 months in the control arm.

Safety data from the inMIND trial, which included 546 patients, indicated serious adverse reactions in 33% of patients receiving Monjuvi, including serious infections in 24% of them.

Other adverse reactions included renal insufficiency, second primary malignancies, and febrile neutropenia, with fatal reactions occurring in 1.5% of patients.

Incyte, which acquired exclusive rights to further develop and commercialise Monjuvi in February 2024, offers eligible US patients access to the IncyteCARES programme.

The initiative provides personalised support, financial assistance, and educational resources to patients undergoing treatment with Monjuvi.

Earlier this year, Incyte entered a strategic collaboration with Genesis Therapeutics, a biotechnology company focused on AI technologies.

The collaboration is focused on the research, discovery and development of novel small-molecule medicines, with an initial focus on targets selected by Incyte.