Regulatory approval
Published by the Food and Drug Administration.
The U.S. Food and Drug Administration granted approval to dostarlimab in combination with carboplatin and paclitaxel, followed by dostarlimab as a single agent, for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR), as determined by an FDA-approved test, or microstallite instability-high (MSI-H).
This is written in the approval document as:
JEMPERLI is a programmed death receptor-1 (PD-1)-blocking antibody indicated in combination with carboplatin and paclitaxel, followed by JEMPERLI as a single agent for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR), as determined by an FDA-approved test, or microstallite instability-high (MSI-H).
Citation
Therapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.
| Type | Biomarker(s) | Cancer type | Therapy(ies) | |
|---|---|---|---|---|
| Sensitivity (+) | dMMR | Endometrial Carcinoma | Carboplatin, Dostarlimab, Paclitaxel | |
| Sensitivity (+) | MSI-H | Endometrial Carcinoma | Carboplatin, Dostarlimab, Paclitaxel |