dostarlimab

1 INDICATIONS AND USAGE JEMPERLI 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 (EC). ( 1.1 ) • as a single agent for the treatment of adult patients with mismatch repair deficient (dMMR) recurrent or advanced EC, 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. ( 1.1 , 2.1 ) 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. 1 ( 1.2 , 2.1 ) 1 This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ( 1.2 ) 1.1 Endometrial Cancer JEMPERLI, in combination with carboplatin and paclitaxel, followed by JEMPERLI as a single agent, is indicated for the treatment of adult patients with primary advanced or recurrent endometrial cancer (EC). JEMPERLI, as a single agent, is indicated for the treatment of adult patients with mismatch repair deficient (dMMR) recurrent or advanced EC, 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 [see Dosage and Administration ( 2.1 )]. 1.2 Mismatch Repair Deficient Recurrent or Advanced Solid Tumors JEMPERLI, as a single agent, is indicated 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 [see Dosage and Administration ( 2.1 )]. This indication is approved under accelerated approval based on tumor response rate and durability of response [see Clinical Studies ( 14.2 )]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).