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AUMN 0.275 +0.0% GGX 0.040 +0.0% S 0.155 +29.2% NNX 0.035 +0.0% ABX 51.90 −0.6% TTS 2.40 −4.0% FCI 0.400 −9.1% GR 0.075 +0.0% AII 23.38 +12.4% TUNG 1.72 +1.8% LGO 1.01 −2.9% EMM 0.080 +0.0% OGN 3.45 +2.1% MSA 6.67 +3.7% SGZ 0.040 −11.1% GRSL 0.310 −3.1% AUMN 0.275 +0.0% GGX 0.040 +0.0% S 0.155 +29.2% NNX 0.035 +0.0% ABX 51.90 −0.6% TTS 2.40 −4.0% FCI 0.400 −9.1% GR 0.075 +0.0% AII 23.38 +12.4% TUNG 1.72 +1.8% LGO 1.01 −2.9% EMM 0.080 +0.0% OGN 3.45 +2.1% MSA 6.67 +3.7% SGZ 0.040 −11.1% GRSL 0.310 −3.1%
Regulatory

Knight wins Anvisa approval for Minjuvi use in Brazil

By The Northwire Desk — AI Analysis Mar 17, 2026 · 17:30 GUD · 6.15 Knight Therapeutics Inc
GUD · Price

Executive Summary

  • Anvisa approved Minjuvi® (tafasitamab) in Brazil for a new indication: treatment of adult patients with relapsed or refractory follicular lymphoma (FL) in combination with rituximab and lenalidomide.
  • The approval is based on positive Phase 3 inMIND trial data showing significantly improved progression‑free survival versus placebo plus R2.
  • The decision expands Knight Therapeutics’ commercial footprint for Minjuvi across Latin America, adding FL to the previously approved DLBCL indication in Brazil.

Key Details

  • Regulatory body: Anvisa (Brazilian health agency) under Project Orbis.
  • Product: Minjuvi® (tafasitamab), humanized Fc‑modified CD19‑targeting monoclonal antibody.
  • New approved indication: Relapsed or refractory follicular lymphoma (FL) – adult patients – in combination with rituximab and lenalidomide (R2).
  • Existing Brazilian indications: Minjuvi + lenalidomide followed by monotherapy for relapsed/refractory diffuse large B‑cell lymphoma (DLBCL) not eligible for autologous stem cell transplant.
  • Supporting clinical data: inMIND Phase 3 study (INCMOR 0208‑301) – 273 patients received tafasitamab + R2 vs 275 placebo + R2. Median PFS: 22.37 mo vs 13.93 mo; HR = 0.434; p < 0.0001 (57% risk reduction).
  • Safety profile: Most common ≥20% adverse events – respiratory infections, diarrhea, rash, fatigue, constipation, musculoskeletal pain, cough; Grade 3‑4 labs – neutrophil and lymphocyte decreases.
  • Supply agreement: Knight holds exclusive supply/distribution rights with Incyte (Nasdaq: INCY) for tafasitamab across Latin America (agreement signed 2021).
  • Commercial status: Minjuvi already launched in Brazil, Mexico, Argentina for DLBCL; now also marketed for FL.
  • Quotes:
  • Dr. Jorge Vaz Pinto Neto highlighted the new chemotherapy‑free option for Brazilian patients.
  • Samira Sakhia (President & CEO) emphasized Knight’s regulatory capabilities and the benefit to partners.

Notable Quotes

“Anvisa's approval of the new indication for tafasitamab in combination with rituximab and lenalidomide represents an important step in expanding treatment options for patients with relapsed or refractory follicular lymphoma.” – Dr. Jorge Vaz Pinto Neto

“The rapid review and approval under Project Orbis reflect Knight's strong regulatory capabilities and focused execution for the benefit of Knight and our partners.” – Samira Sakhia, President & CEO, Knight Therapeutics

Read the original news release →

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