Incyte Corporation reported positive topline results from the Phase III inMIND clinical trial of its CD19-targeting monoclonal antibody Monjuvi (tafasitamab) in relapsed or refractory follicular lymphoma (FL) on 16 August and said it will file a supplemental biologics license application (sBLA) with the US Food and Drug Administration for the indication by the end of this year. FL is one of two indications the company is targeting for near- to mid-term growth in an increasingly crowded drug class.
Incyte To Seek Another Monjuvi Approval In Crowded CD19-Targeting Market
Interest Growing Across Indications
Incyte reported positive topline Phase III results for Monjuvi in relapsed or refractory follicular lymphoma and plans to file for US FDA approval by the end of 2024.
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A decision from the FDA is due by 28 September.