What is the generic name?

DOSTARLIMAB

What is the Trade Name for DOSTARLIMAB?

Jemperli

What are the Indications for DOSTARLIMAB?

• 1 INDICATIONS AND USAGE JEMPERLI is indicated for the treatment of adult patients with mismatch repair deficient (dMMR) recurrent or advanced: ‚Ä¢ endometrial cancer (EC), as determined by an FDA-approved test, that has progressed on or following prior treatment with a platinum-containing regimen, or ‚Ä¢ 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 )] . These indications are approved under accelerated approval based on tumor response rate and durability of response [see Clinical Studies ( 14 )] . Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). JEMPERLI is a programmed death receptor-1 (PD-1)‚Äìblocking antibody indicated for the treatment of adult patients with mismatch repair deficient (dMMR) recurrent or advanced: ‚Ä¢ endometrial cancer, as determined by an FDA-approved test, that has progressed on or following prior treatment with a platinum-containing regimen, or ‚Ä¢ 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 , 2.1 ) These indications are approved under accelerated approval based on tumor response rate and durability of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ( 1 )

References: https://open.fda.gov/