Difference between revisions of "Dostarlimab (Jemperli)"

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==History of changes in FDA indication==
 
==History of changes in FDA indication==
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===[[Endometrial cancer]]===
 
*4/22/2021: Granted accelerated approval for adult patients with [[Biomarkers#dMMR|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)''
 
*4/22/2021: Granted accelerated approval for adult patients with [[Biomarkers#dMMR|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)''
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===[[MSI-H or dMMR|MSI-H or dMMR tumors (tissue-agnostic)]]===
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*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)''
  
 
==Also known as==
 
==Also known as==
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[[Category:Anti-PD-1 antibodies]]
 
[[Category:Anti-PD-1 antibodies]]
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[[Category:Endometrial cancer medications]]
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[[Category:MSI-H or dMMR medications]]
  
 
[[Category:FDA approved in 2021]]
 
[[Category:FDA approved in 2021]]
 
[[Category:GlaxoSmithKline product]]
 
[[Category:GlaxoSmithKline product]]

Revision as of 20:21, 18 August 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)

Also known as

  • Code name: TSR-042
  • Generic name: dostarlimab-gxly
  • Brand name: Jemperli