U.S. License Holder:
GlaxoSmithKline
Date of License:
April-22-2021 [August-17-2021]
Last Update:
Sep-23-2023
FDA-Approved Indications
BL 761174: JEMPERLI (dostarlimab-gxly) is a programmed death receptor-1 (PD-1)-blocking antibody indicated:
Endometrial cancer: 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 microsatellite instability-high (MSI-H); As a single agent for the treatment of adult patients with dMMR recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that has progressed on or following prior treatment with a platinum-containing regimen in any setting and are not candidates for curative surgery or radiation;
Mismatch Repair Deficient Recurrent or Advanced Solid Tumors: As a single agent for the treatment of adult patients with dMMR recurrent or advanced solid tumors, as determined by an FDA-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options.
BL 761223: JEMPERLI (dostarlimab-gxly) is a programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of adult patients with mismatch repair deficient (dMMR) recurrent or advanced:
Edometrial cancer, as determined by an FDA-approved test, that has progressed on or following prior treatment with a platinum-containing regimen, or
Solid tumors, as determined by an FDA-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options.
