Incyte Gets FDA Nod for the Expanded Use of Monjuvi in Lymphoma

Core Insights - Incyte's Monjuvi (tafasitamab-cxix) received FDA approval for a new indication in combination with Rituxan and Revlimid for treating adult patients with relapsed or refractory follicular lymphoma (FL) [1][2][8] - This marks the second approved indication for Monjuvi in the U.S. and establishes it as the first CD19- and CD20-targeted immunotherapy combination approved for FL [2][8] - The approval was based on the pivotal phase III inMIND study, which demonstrated significant improvement in progression-free survival (PFS) [6][7][8] Company Performance - Incyte's shares have decreased by 1.1% year-to-date, while the industry has seen a decline of 4.8% [5] - Monjuvi's revenues reached $29.6 million in Q1 2025, reflecting a 24% year-over-year increase, with expectations for further sales growth due to the expanded label [10] Clinical Data - The inMIND study showed a median PFS of 22.4 months for patients treated with Monjuvi, Rituxan, and Revlimid, compared to 13.9 months in the control group [9]