Knight launches Minjuvi in Argentina for DLBCL patients

Executive Summary

• Knight Therapeutics’ Argentine affiliate obtained ANMAT approval and launched Minjuvi® (tafasitamab) in Argentina for relapsed/refractory DLBCL patients ineligible for ASCT.
• The launch marks the third Latin American country introduction of Minjuvi, expanding Knight’s commercial footprint in the region.
• Approval is based on Phase 2 L‑MIND trial data showing a 60% objective response rate (43% complete responses) and a 74% disease control rate.

Key Details

• Regulatory approval: ANMAT approved Minjuvi (tafasitamab) in combination with lenalidomide, followed by monotherapy, for adult relapsed/refractory DLBCL patients not eligible for autologous stem cell transplantation.
• Launch location: Argentina – third Latin American market after prior launches elsewhere.
• Clinical data supporting approval: L‑MIND Phase 2 trial (open‑label, multicentre, single‑arm) reported:
• Objective response rate (ORR): 60%
• Complete response (CR) rate: 43%
• Disease control rate (DCR): 74%
• Guideline status: Listed as a preferred second‑line therapy for this patient population in the 2024 NCCN guidelines.
• Supply & distribution agreement: Knight holds exclusive rights to distribute tafasitamab/Minjuvi in Latin America under its 2021 agreement with Incyte.
• Future regulatory activity: A supplemental application submitted to Brazil’s ANVISA (July 2025) seeks approval for Minjuvi combined with rituximab and lenalidomide for previously treated follicular lymphoma; the application is under Project Orbis review.
• Quotes:
• Dr. Amalia Cerutti highlighted Minjuvi’s innovative CD19‑targeted mechanism and its potential to deliver sustained remission.
• Samira Sakhia, President & CEO, emphasized the launch as a milestone expanding patient access in Latin America.

Notable Quotes

• “Minjuvi has a unique and innovative mechanism of action targeting CD19 and represents a significant advancement in the treatment of DLBCL… I am enthusiastic about the transformative potential of Minjuvi in improving patient outcomes.” – Dr. Amalia Cerutti
• “With the approval and launch of Minjuvi in Argentina, we mark the third country launch in Latin America for this innovative product… offering new treatment choices.” – Samira Sakhia, President & CEO, Knight Therapeutics

Materiality: Material – Positive (new regulatory approval and market entry expanding commercial presence).