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Retifanlimab - Incyte Corporation/MacroGenics

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Drug Profile

Retifanlimab - Incyte Corporation/MacroGenics

Alternative Names: AEX-1188; INCMGA-0012; INCMGA00012; MGA-012; Retifanlimab-dlwr; Zynyz

Latest Information Update: 03 Jun 2025

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At a glance

  • Originator MacroGenics
  • Developer BriaCell Therapeutics Corp; Incyte Corporation; MacroGenics; University of Washington; ZAI Lab
  • Class Antineoplastics; Immunotherapies; Monoclonal antibodies
  • Mechanism of Action Antibody-dependent cell cytotoxicity; Programmed cell death 1 receptor antagonists; T lymphocyte stimulants
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Anal cancer; Merkel cell carcinoma
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Merkel cell carcinoma; Squamous cell cancer
  • Phase III Endometrial cancer; Non-small cell lung cancer
  • Phase II Adenosquamous carcinoma; Bladder cancer; Gastric cancer; Glioblastoma; Glioma; Head and neck cancer; Liposarcoma; Oesophageal cancer; Pancreatic cancer; Penile cancer; Sarcoma; Solid tumours; Triple negative breast cancer
  • Phase I/II Breast cancer; Colorectal cancer; Malignant melanoma; Soft tissue sarcoma
  • Phase I Adenocarcinoma
  • No development reported Acute myeloid leukaemia; Haematological malignancies

Most Recent Events

  • 15 May 2025 Launched for Squamous cell cancer (Metastatic disease, Combination therapy, First-line therapy, Recurrent) in USA (IV)
  • 15 May 2025 Launched for Squamous cell cancer (Second-line therapy or greater, Recurrent, Metastatic disease, Monotherapy) in USA (IV)
  • 15 May 2025 Preregistration for Squamous cell cancer (Late-stage disease) in Japan (IV), before May 2025

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