Drug Profile

Retifanlimab - Incyte Corporation/MacroGenics

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

Latest Information Update: 02 Sep 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
Preregistration Non-small cell lung cancer
Phase III Breast cancer; Endometrial 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
No development reported Acute myeloid leukaemia; Adenocarcinoma; Haematological malignancies

13 Aug 2026 Preregistration for Non-small cell lung cancer (Metastatic disease, Late-stage disease, Combination therapy, First-line therapy) in USA (IV) before August 2026
13 Aug 2026 Incyte submits phase III POD1UM-304 study data to US FDA in response to complete response letter in Non-small cell lung cancer before August 2016
13 Aug 2026 The US FDA issues complete response letter citing manufacturing issues at Novo Nordisk’s Catalent-acquired site for retifanlimab sBLA in Non-small cell lung cancer before August 2026

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