JEMPERLI (GlaxoSmithKline Australia Pty Ltd)
Product name
JEMPERLI
Date registered
Evaluation commenced
Decision date
Approval time
208 (255 working days)
Active ingredients
dostarlimab
Registration type
NCE/NBE
Indication
JEMPERLI (solution for infusion) is indicated as monotherapy for the treatment of adult patients with recurrent or advanced mismatch repair deficient (dMMR) endometrial cancer (EC) that has progressed on or following prior treatment with a platinum-containing regimen.
This medicine and indication have provisional approval, based on objective response rate and duration of response in a single-arm trial. Full registration for this indication depends on verification and description of clinical benefit in confirmatory trials.
Registration process
Provisional registration
Involves early access to vital and life-saving medicines through time-limited registration