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.

Business candle stick graph chart of stock market investment trading on blue background — Follicular lymphoma may help Monjuvi revenue grow into the hundreds of millions of dollars • Source: Shutterstock

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.

Key Takeaways

Incyte plans to seek US FDA approval for Monjuvi in relapsed or refractory follicular lymphoma (FL) by the end of 2024 based on positive topline results from the inMIND study.

In February, Wilmington, DE-based Incyte agreed to pay $25m to obtain exclusive global rights to Monjuvi from its partner