FDA grants accelerated approval to GSK Jemperli for MSI-H or dMMR locally advanced rectal cancer
The FDA has granted accelerated approval to GSK's Jemperli for previously untreated MSI-H or dMMR locally advanced rectal cancer, introducing a potentially organ-preserving immunotherapy approach.
Jemperli (dostarlimab-gxly), a PD-1 inhibitor, is now authorised for adults with Stage II or III locally advanced rectal cancer characterised by microsatellite instability-high or mismatch repair-deficient disease, as identified by an FDA-authorised test.
The decision was supported by the single-arm Phase II AZUR-1 study involving 154 patients and may enable some eligible individuals to avoid conventional chemotherapy, radiation or surgery, subject to clinical assessment and follow-up.
Field | Content |
Article Type | Approvals |
Drug Name | Jemperli |
Generic Name | Dostarlimab-gxly |
Company | GSK |
Regulatory Authority | U.S. Food and Drug Administration |
Regulatory Decision | Accelerated approval |
Approval Date | 19 October 2026 |
New Indication | Previously untreated locally advanced rectal cancer with MSI-H or dMMR status |
Patient Population | Adults with Stage II or III locally advanced MSI-H or dMMR rectal cancer |
Biomarker Requirement | Microsatellite instability-high or mismatch repair-deficient status determined by an FDA-authorised test |
Therapeutic Area | Oncology; colorectal cancer |
Drug Class | PD-1 immune checkpoint inhibitor |
Mechanism of Action | PD-1 inhibition |
Supporting Clinical Study | Phase II AZUR-1 |
Clinical Trial Design | Single-arm Phase II study |
Study Population | 154 patients |
Potential Clinical Benefit | May allow selected patients to avoid chemotherapy, radiation or surgery depending on response and clinical assessment |
Geography | United States |
What Happened | The FDA granted accelerated approval to Jemperli for previously untreated Stage II or III MSI-H or dMMR locally advanced rectal cancer. |
Why It Matters | The approval introduces an immunotherapy approach that may reduce the need for conventional multimodal treatment in a biomarker-defined patient population. |
Clinical Evidence | The decision was supported by the Phase II AZUR-1 study involving 154 patients; specific response statistics were not provided in the supplied summary. |
Regulatory Context | Accelerated approval; any confirmatory requirements were not specified in the supplied summary |
Key Takeaway | Jemperli is now authorised for eligible adults with previously untreated MSI-H or dMMR locally advanced rectal cancer under the FDA's accelerated approval pathway. |
What to Watch | Confirmatory evidence requirements, longer-term outcomes, organ preservation, clinical guideline updates and real-world adoption. |
Primary Source | U.S. Food and Drug Administration |
Primary Source URL | https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-dostarlimab-locally-advanced-rectal-cancer |
Relevant Date | 19 October 2026 |
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