Northwire Canada EditionSunday, October 18, 2026
Sign inSubscribe
Northwire
⌕
GOLD 4181.10 +0.3% SILVER 57.30 +0.3% COPPER 6.57 +0.3% OIL 99.02 +1.1% PALLADIUM 1118.60 −0.9% GBU 0.095 +0.0% ATY 0.225 +4.7% GRDM 0.215 +0.0% PPM 0.300 +0.0% GZD 0.040 −11.1% CAN 0.060 +0.0% BGF 0.025 +0.0% MSV 0.570 +0.0% CCMM 0.485 +0.0% MON 0.385 −6.1% OMI 0.245 −2.0% BUFF 0.800 +2.6% FEO 0.630 −3.1% LIB 0.710 −1.4% NPR 0.620 +0.0% QZM 0.380 +0.0% GOLD 4181.10 +0.3% SILVER 57.30 +0.3% COPPER 6.57 +0.3% OIL 99.02 +1.1% PALLADIUM 1118.60 −0.9% GBU 0.095 +0.0% ATY 0.225 +4.7% GRDM 0.215 +0.0% PPM 0.300 +0.0% GZD 0.040 −11.1% CAN 0.060 +0.0% BGF 0.025 +0.0% MSV 0.570 +0.0% CCMM 0.485 +0.0% MON 0.385 −6.1% OMI 0.245 −2.0% BUFF 0.800 +2.6% FEO 0.630 −3.1% LIB 0.710 −1.4% NPR 0.620 +0.0% QZM 0.380 +0.0%
Regulatory

Knight launches Minjuvi in Argentina for DLBCL patients

By The Northwire Desk — AI Analysis Oct 30, 2025 · 16:23 GUD · 5.8 Knight Therapeutics Inc
GUD · Price

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).

Read the original news release →

More from Knight Therapeutics Inc

Jun 17, 2026 · 17:30

Debt-free balance sheet achieved ahead of schedule, but the credit win was already telegraphed by Q1 cash flow and priced into the +11% run-up.

Other Jun 05, 2026 · 18:00

Knight Announces Early Warning Filing Regarding Shares of Crescita

M&A / Property May 27, 2026 · 18:00

LATAM Expansion Validates Growth Strategy But FX and Generic Risks Loom

Other May 08, 2026 · 06:30

Knight Therapeutics scores Brazilian approval for TAVALISSE just as record sales lift stock to all‑time high

Regulatory May 07, 2026 · 06:30

Knight Therapeutics Q1 Earnings Beat Drives Guidance Hike Amidst LATAM Expansion

Earnings Mar 19, 2026 · 07:30

Knight Therapeutics Reports Fourth Quarter and Year-End 2025 Results

Earnings