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Regulatory

Knight Therapeutics Announces Regulatory Supplemental Submission of MINJUVI(TM) (tafasitamab) for Follicular Lymphoma in Argentina and Mexico

By The Northwire Desk — AI Analysis Mar 17, 2026 · 07:30 GUD · 6.14 KNIGHT THERAPEUTICS INC.
GUD · Price

Executive Summary

  • Knight Therapeutics’ Argentine and Mexican affiliates have filed supplemental applications with ANMAT and COFEPRIS to obtain approval for MINJUVI® (tafasitamab) in combination with lenalidomide and rituximab for relapsed/refractory follicular lymphoma (FL).
  • The submissions follow successful launches of MINJUVI® in Brazil, Mexico, and Argentina for diffuse large B‑cell lymphoma (DLBCL) and a recent approval for FL in Brazil.
  • Expansion of the MINJUVI® label into additional Latin American markets could significantly broaden Knight’s commercial footprint and revenue potential for this oncology portfolio.

Key Details

  • Regulatory filings:
  • Laboratorio LKM S.A. (Argentina) – supplemental application to ANMAT.

  • Grupo Biotoscana de Especialidad S.A. de C.V. (Mexico) – supplemental application to COFEPRIS.

  • Indication sought: MINJUVI® + lenalidomide + rituximab for adult patients with relapsed or refractory follicular lymphoma (Grade 1‑3a) after ≥ one prior systemic therapy line.

  • Current market presence:

  • Exclusive Latin America supply/distribution agreement with Incyte (Sept 2021).

  • MINJUVI® launched in Brazil, Mexico, Argentina for DLBCL; approved in Brazil for FL (Mar 2026).

  • Clinical background:

  • Phase 3 inMIND study demonstrated median PFS of 22.37 months vs 13.93 months (HR 0.434, p < 0.0001) for tafasitamab + R2 versus placebo + R2 in relapsed/refractory FL/MZL.

  • Strategic significance:

  • Adds a new indication to the product’s label across two major Latin American markets.

  • Enhances Knight’s portfolio depth, potentially increasing sales volume and market share in oncology.

  • CEO comment (Samira Sakhia): Emphasized progress of MINJUVI® launches, recent FL approval in Brazil, and the importance of expanding indications to meet diverse patient needs.

Notable Quotes

“We continue to advance our pipeline with the submissions for MINJUVI® in both Argentina and Mexico… MINJUVI® is more than a single product. With approvals across distinct indications, it effectively represents multiple therapies within one brand…” – Samira Sakhia, President & CEO, Knight Therapeutics

Materiality Assessment: Material – Positive (potential to generate additional revenue streams and broaden market coverage).

Read the original news release →

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