Dostarlimab (Jemperli)
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General information
Class/mechanism: PD-1 receptor antibody.
Route: IV
Extravasation: no information
For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.
Toxicity management
Diseases for which it is established
History of changes in FDA indication
Endometrial cancer
- 2021-04-22: Granted accelerated approval for adult patients with mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that has progressed on or following a prior platinum-containing regimen. (Based on GARNETendometrial)
- 2023-02-09: Regular approval for adult patients with mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that has progressed on or following a prior platinum-containing regimen in any setting and are not candidates for curative surgery or radiation. (Based on GARNETendometrial)
- 2023-07-31: Approved in combination with carboplatin and paclitaxel, followed by single-agent dostarlimab-gxly, for primary advanced or recurrent endometrial cancer (EC) that is mismatch repair deficient (dMMR), as determined by an FDA-approved test, or microsatellite instability-high (MSI-H). (Based on RUBY)
MSI-H or dMMR tumors (tissue-agnostic)
- 2021-08-17: Granted accelerated approval for adult patients with mismatch repair deficient (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. (Based on GARNETMSI-H)
History of changes in EMA indication
- 2021-04-21: Initial conditional authorization at Jemperli. Jemperli is indicated as monotherapy for the treatment of adult patients with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) recurrent or advanced endometrial cancer (EC) that has progressed on or following prior treatment with a platinum-containing regimen.
- 2023-10-12: CHMP adopted new indication Jemperli is indicated in combination with carboplatin and paclitaxel for the treatment of adult patients with mismatch repair deficient (dMMR)/ microsatellite instability high (MSI H) primary advanced or recurrent endometrial cancer (EC) and who are candidates for systemic therapy.
History of changes in Health Canada indication
- 2021-12-23: Initial notice of compliance with conditions as a monotherapy for the treatment of adult patients with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) recurrent or advanced endometrial cancer (EC) that has progressed on or following prior treatment with a platinum containing regimen.
Also known as
- Code name: TSR-042
- Generic name: dostarlimab-gxly
- Brand name: Jemperli