Drug Profile

Dostarlimab - GSK

Alternative Names: ANB 011; Dostarlimab-gxly; GSK-4057190; GSK-4057190A; JEMPERLI; Jemperli; TSR 042; WBP 285

Latest Information Update: 24 Apr 2025

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At a glance

Originator AnaptysBio
Developer GSK; Italian Sarcoma Group
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.

No
New Molecular Entity Yes

Marketed Endometrial cancer; Solid tumours
Phase III Adenocarcinoma; Fallopian tube cancer; Ovarian cancer; Peritoneal cancer; Squamous cell cancer
Phase II/III Non-small cell lung cancer
Phase II Breast cancer; Cervical cancer; Clear cell sarcoma; Colorectal cancer; Liver cancer; Malignant melanoma; Neuroendocrine tumours; Pancreatic cancer; Rectal cancer; Small cell lung cancer

17 Apr 2025 Health Canada approves dostarlimab in Endometrial cancer (Combination therapy, Late stage disease, Recurrent, First line therapy)
04 Apr 2025 GlaxoSmithKline terminates the phase-II trial in Non-small cell lung cancer (Combination therapy, First-line therapy, Metastatic disease) in USA, Chile, Argentina, Brazil, France, Germany, Italy, Poland, Romania, Spain, South Korea, Taiwan (IV) due to strategic reasons (NCT04581824)
04 Apr 2025 GSK withdraws a phase II trial in Ovarian cancer (Combination therapy, Late-stage disease, Recurrent, Second-line therapy or greater) prior to enrollment since it was never submitted to competent authority nor to ethics committee (NCT05126342) (EUCT2021-003572-14)

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