Difference between revisions of "Serplulimab (Hansizhuang)"

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==Diseases for which it is used==
 
==Diseases for which it is used==
*[[MSI-H or dMMR|MSI-H or dMMR solid tumors (tissue-agnostic)]]
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*[[Malignant solid neoplasm, MSI-H or dMMR|MSI-H or dMMR solid tumors (tissue-agnostic)]]
 
*[[Small cell lung cancer]]
 
*[[Small cell lung cancer]]
  
 
==History of changes in NMPA indication==
 
==History of changes in NMPA indication==
*2022-03-25: Initial approval for the treatment of adult patients with advanced unresectable or metastatic MSI-H (Microsatellite Instability-High) [[:Category:Malignant solid neoplasm|solid tumors]] that have failed to respond to previous standard treatments.
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*2022-03-25: Initial approval for the treatment of adult patients with advanced unresectable or metastatic MSI-H (Microsatellite Instability-High) [[:Category:Malignant solid neoplasm|solid tumors]] that have failed to respond to previous standard treatments. ''(Based on HLX10-010-MSI201)''
 
*2022-11-01: Approved in combination with carboplatin and albumin-bound paclitaxel for the first-line treatment of unresectable locally advanced or metastatic [[Non-small cell lung cancer, squamous|squamous non-small cell lung cancer (sqNSCLC)]]. ''(Based on ASTRUM-004)''
 
*2022-11-01: Approved in combination with carboplatin and albumin-bound paclitaxel for the first-line treatment of unresectable locally advanced or metastatic [[Non-small cell lung cancer, squamous|squamous non-small cell lung cancer (sqNSCLC)]]. ''(Based on ASTRUM-004)''
 
*2023-01-18: Approved for ES-[[Small cell lung cancer|SCLC]] in combination with carboplatin & etoposide. ''(Based on ASTRUM-005)''
 
*2023-01-18: Approved for ES-[[Small cell lung cancer|SCLC]] in combination with carboplatin & etoposide. ''(Based on ASTRUM-005)''
  
 
==Also known as==
 
==Also known as==
*'''Code name:''' HLX10
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*'''Code name:''' HLX-10
 
*'''Brand name:''' Hansizhuang
 
*'''Brand name:''' Hansizhuang
  
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[[Category:Anti-PD-1 antibodies]]
 
[[Category:Anti-PD-1 antibodies]]
  
[[Category:MSI-H or dMMR medications]]
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[[Category:Malignant solid neoplasm, MSI-H or dMMR medications]]
 +
[[Category:Non-small cell lung cancer, squamous medications]]
 
[[Category:Small cell lung cancer medications]]
 
[[Category:Small cell lung cancer medications]]
  
 
[[Category:NMPA approved in 2022]]
 
[[Category:NMPA approved in 2022]]

Latest revision as of 01:17, 23 May 2024

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 used

History of changes in NMPA indication

  • 2022-03-25: Initial approval for the treatment of adult patients with advanced unresectable or metastatic MSI-H (Microsatellite Instability-High) solid tumors that have failed to respond to previous standard treatments. (Based on HLX10-010-MSI201)
  • 2022-11-01: Approved in combination with carboplatin and albumin-bound paclitaxel for the first-line treatment of unresectable locally advanced or metastatic squamous non-small cell lung cancer (sqNSCLC). (Based on ASTRUM-004)
  • 2023-01-18: Approved for ES-SCLC in combination with carboplatin & etoposide. (Based on ASTRUM-005)

Also known as

  • Code name: HLX-10
  • Brand name: Hansizhuang