Retifanlimab - Incyte Corporation/MacroGenics
Alternative Names: AEX-1188; INCMGA-0012; INCMGA00012; MGA-012; Retifanlimab-dlwr; ZynyzLatest Information Update: 03 Jun 2025
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
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Orphan Drug Status
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- 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