Difference between revisions of "Dostarlimab (Jemperli)"
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===[[MSI-H or dMMR|MSI-H or dMMR tumors (tissue-agnostic)]]=== | ===[[MSI-H or dMMR|MSI-H or dMMR tumors (tissue-agnostic)]]=== | ||
*8/17/2021: Granted accelerated approval for adult patients with [[Biomarkers#dMMR|mismatch repair deficient (dMMR)]] recurrent or advanced [[:Category:Malignant solid neoplasm|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 GARNET)'' | *8/17/2021: Granted accelerated approval for adult patients with [[Biomarkers#dMMR|mismatch repair deficient (dMMR)]] recurrent or advanced [[:Category:Malignant solid neoplasm|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 GARNET)'' | ||
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| + | ==History of changes in EMA indication== | ||
| + | *4/21/2021: Initial marketing authorization at Jemperli. | ||
==Also known as== | ==Also known as== | ||
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[[Category:MSI-H or dMMR medications]] | [[Category:MSI-H or dMMR medications]] | ||
| + | [[Category:EMA approved in 2021]] | ||
[[Category:FDA approved in 2021]] | [[Category:FDA approved in 2021]] | ||
[[Category:GlaxoSmithKline product]] | [[Category:GlaxoSmithKline product]] | ||
Revision as of 03:27, 5 December 2021
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.
Diseases for which it is used
History of changes in FDA indication
Endometrial cancer
- 4/22/2021: 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 GARNET)
MSI-H or dMMR tumors (tissue-agnostic)
- 8/17/2021: 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 GARNET)
History of changes in EMA indication
- 4/21/2021: Initial marketing authorization at Jemperli.
Also known as
- Code name: TSR-042
- Generic name: dostarlimab-gxly
- Brand name: Jemperli