Incyte Seeks Expanded Approval for Monjuvi Following Successful Phase III Trial in Follicular Lymphoma

Phase III Trial Success:
Incyte has announced positive results from the Phase III inMIND study evaluating Monjuvi (tafasitamab) in patients with relapsed or refractory follicular lymphoma.

Label Expansion Plans:
The company plans to submit a supplemental biologics license application by the end of 2024 to expand Monjuvi's label as a second-line treatment for follicular lymphoma.

Current Approval:
Monjuvi is currently approved in the US as a second-line treatment for relapsed or refractory diffuse large B-cell lymphoma (DLBCL) when used in combination with lenalidomide.

Market Performance:
Monjuvi generated $92 million in sales in the US last year, with projections indicating sales could exceed $400 million by 2030.

Competitive Landscape:
The treatment landscape for follicular lymphoma is competitive, with other approved therapies including BeiGene's zanubrutinib and CAR-T cell therapies like Novartis' Kymriah and Gilead Sciences' Yescarta.

Acquisition and Partnership:
Incyte acquired exclusive global development and commercialization rights to tafasitamab (Monjuvi) from MorphoSys AG in February 2024.