Drug Profile

Retifanlimab - Incyte Corporation/MacroGenics

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

Latest Information Update: 16 Mar 2026

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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

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

07 Mar 2026 Registered for Squamous cell cancer (Late-stage disease, First-line therapy, Inoperable/Unresectable, Combination therapy, Metastatic disease, Recurrent) in European Union (IV)
30 Jan 2026 Preregistration for Squamous cell cancer (Combination therapy, First-line therapy, Metastatic disease, Recurrent, Inoperable/Unresectable, Late-stage disease) in European Union (IV)
30 Jan 2026 The CHMP of the EMA adopts a positive opinion recommending approval of Retifanlimab in combination with carboplatin and paclitaxel for the first-line treatment of Advanced squamous cell carcinoma of the anal canal

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