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Incyte’s Monjuvi Regimen Receives the US FDA Approval for R/R Follicular Lymphoma

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  • The US FDA has approved Monjuvi (tafasitamab-cxix) + rituximab & lenalidomide for the treatment of adult pts with r/r follicular lymphoma (FL)
  • Approval was based on the P-III (inMIND) trial assessing Monjuvi regimen vs PBO + rituximab & lenalidomide in adults (n=654) with r/r Grade 1 to 3a FL or r/r nodal, splenic or extranodal MZL
  • Trial met its 1EP of improved investigator-based PFS (mPFS: 22.4 vs 13.9mos.), showing 27.5% vs 47.6% pts with an event; PFS per IRC was consistent (mPFS: was not reached vs 16mos.), with PFS benefit seen across all pts subgroups, incl. no. of prior lines of treatment. Data was shared at ASH 2025

Ref: Businesswire | Image: Incyte| Press Release

Related News:- Bayer Reports the US FDA’s NDA Submission of Gadoquatrane for Contrast-Enhanced MRI

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