Knight Therapeutics seeks OK for new Minjuvi indication

Executive Summary

• Knight Therapeutics announced the submission of a regulatory supplemental application to Anmat (Argentina) and Cofepris (Mexico) seeking approval for Minjuvi (tafasitamab) for a new indication: treatment of adult patients with relapsed or refractory follicular lymphoma (FL) in combination with lenalidomide and rituximab.
• This follows the company's previous launches of Minjuvi in Brazil, Mexico, and Argentina for diffuse large B-cell lymphoma (DLBCL), and the recent approval and launch of Minjuvi for FL in Brazil in March 2026.
• The submission is based on data from the phase 3 inMIND study, which demonstrated statistically significant improvements in progression-free survival (PFS) for patients receiving tafasitamab plus R2 therapy compared to placebo plus R2.

Key Details

• Regulatory Action: Submitted supplemental applications to Anmat (Argentina) and Cofepris (Mexico) for Minjuvi (tafasitamab).
• Target Indication: Treatment of adult patients with relapsed or refractory follicular lymphoma (FL) (Grade 1-3a) after at least one prior line of systemic therapy.
• Treatment Regimen: Minjuvi in combination with lenalidomide and rituximab.
• Commercial Context: Knight Therapeutics holds an exclusive supply and distribution agreement with Incyte for tafasitamab (Minjuvi ex-U.S.) across Latin America, entered into in September 2021.
• Recent Milestones:
  • Minjuvi launched in Brazil, Mexico, and Argentina for DLBCL (combination with lenalidomide, followed by monotherapy).
  • Minjuvi received regulatory approval and launched in Brazil for FL (combination with rituximab and lenalidomide) in March 2026.
• Clinical Data (inMIND Study):
  • Study Design: Phase 3, randomized, double-blind, placebo-controlled, multicentre study.
  • Population: Participants with relapsed/refractory FL or marginal zone lymphoma (MZL) previously treated with at least one prior line of systemic therapy.
  • Primary Endpoint (PFS): Median PFS was 22.37 months (95% CI: 19.22, NE) for tafasitamab + R2 vs. 13.93 months (95% CI: 11.53, 16.39) for placebo + R2.
  • Hazard Ratio: 0.434 (95% CI: 0.324, 0.580), p < 0.0001.
  • Outcome: 57% lower risk of progression, relapse, or death in the tafasitamab group.

Notable Quotes

• "In past two years we have launched Minjuvi for the treatment of diffuse large B-cell lymphoma in Brazil, Mexico and Argentina. More recently, Minjuvi received regulatory approval for the treatment of refractory follicular lymphoma in Brazil," said Samira Sakhia, president and chief executive officer of Knight Therapeutics. "We continue to advance our pipeline with the submissions for Minjuvi in both Argentina and Mexico. More importantly, Minjuvi is more than a single product. With approvals across distinct indications, it effectively represents multiple therapies within one brand, expanding the ways physicians can use Minjuvi to address different patient needs. I am proud of the progress we have made with Minjuvi and look forward to continuing our mission to bring high-quality pharmaceuticals that improve patients' health in our markets."