JEMPERLI (dostarlimag-gxly)

TherapyGSK

JEMPERLI (dostarlimab-gxly) from GSK is a PD-1–directed immunotherapy used in mismatch-repair–deficient tumors.

Approvals

Indications

Biomarkers

Mapped tests

Where this therapy is approved with a companion diagnostic

Each row represents a defined combination of indication, biomarker criteria, and JEMPERLI. Select a testing pathway to see the eligible companion diagnostic tests.

Indication-specific approvals

Approvals where JEMPERLI is tied to a specific indication and biomarker definition.

Indication	Biomarker criteria	Notes
Endometrial Carcinoma (EC) Solid Tumor · Endometrium	deficient mismatch repair (dMMR) proteins MLH1, PMS2, MSH2 and MSH6		View testing pathway →

Tumor-agnostic approvals

Approvals defined at the solid tumor level where biomarker criteria determine eligibility for JEMPERLI.

Level	Biomarker criteria	Notes
Solid Tumors	MSI-High Microsatellite instability-High
Solid Tumors	deficient mismatch repair (dMMR) proteins MLH1, PMS2, MSH2 and MSH6

Tests used in these approvals

These assays are identified in FDA labeling or sponsor materials as companion diagnostics or acceptable tests when considering JEMPERLI for eligible patients.

Test

MI Cancer Seek (MCS)

Caris Life Sciences

Method

NGS

Specimen

Tissue (FFPE)

1 approvalView test profile →

Test

Ventana MMR RxDx Panel

Ventana Medical Systems, Inc. (Roche Diagnostics)

Method

IHC

Specimen

Tissue (FFPE)

2 approvalsView test profile →

This view is scoped to JEMPERLI (dostarlimag-gxly). You can also see how it compares with other therapies and indications on the main Know Your Companions™ map.