Incyte announced the FDA approval of Monjuvi® (tafasitamab-cxix). This advanced CD19-targeting monoclonal antibody, when used in combination with rituximab and lenalidomide, is now approved to treat adult patients battling relapsed or refractory follicular lymphoma (FL). This is a significant milestone for Monjuvi, marking it as the first FDA-approved CD19- and CD20-targeted immunotherapy combination for FL. It also represents Monjuvi's second approved indication in the U.S., further solidifying its role in lymphoma treatment.

This approval is rooted in the strong data from the Phase 3 inMIND trial. The study showcased that patients treated with the Monjuvi combination experienced a statistically significant and clinically meaningful improvement in progression-free survival (PFS). Specifically, the median PFS for these patients stretched to 22.4 months, a notable gain compared to the 13.9 months seen in the control group. This vital benefit was consistently observed across various patient subgroups, highlighting the treatment's broad potential.

Follicular lymphoma is often a chronic and recurring cancer, making the search for effective, long-term treatment options crucial. This new chemotherapy-free combination offers a vital new tool for clinicians and a ray of hope for patients. It addresses a significant unmet need in the FL community by providing a treatment that has demonstrated a meaningful reduction in the risk of disease progression. Incyte is also committed to ensuring patients can access this new therapy through its IncyteCARES program, which provides personalized support, financial assistance, and educational resources.