Difference between revisions of "Tremelimumab (Imjudo)"
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*2023-02-20: Initial authorisation as Imjudo in combination with durvalumab is indicated for the first line treatment of adults with advanced or unresectable [[hepatocellular carcinoma|hepatocellular carcinoma (HCC)]]. | *2023-02-20: Initial authorisation as Imjudo in combination with durvalumab is indicated for the first line treatment of adults with advanced or unresectable [[hepatocellular carcinoma|hepatocellular carcinoma (HCC)]]. | ||
*2023-04-04: Tremelimumab AstraZeneca in combination with durvalumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic [[non-small cell lung cancer|non-small cell lung cancer (NSCLC)]] with no sensitising EGFR mutations or ALK positive mutations. | *2023-04-04: Tremelimumab AstraZeneca in combination with durvalumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic [[non-small cell lung cancer|non-small cell lung cancer (NSCLC)]] with no sensitising EGFR mutations or ALK positive mutations. | ||
| − | + | ==History of changes in PMDA indication== | |
| + | *2022-12-23: Initial approval | ||
==Also known as== | ==Also known as== | ||
*'''Code name:''' CP-675, CP-675206 | *'''Code name:''' CP-675, CP-675206 | ||
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[[Category:FDA approved in 2022]] | [[Category:FDA approved in 2022]] | ||
[[Category:EMA approved in 2023]] | [[Category:EMA approved in 2023]] | ||
| + | [[Category:PMDA approved in 2022]] | ||
Revision as of 20:49, 15 June 2023
General information
Class/mechanism: Anti-CTLA-4 antibody. CTLA-4 is a negative regulator of T-cell activation and ipilimumab interferes with the ability of CTLA-4 to interact with its ligands CD80/CD86. CTLA-4 blockade results in T-cell activation and proliferation, and it is suspected that its anti-neoplastic activity may be due to T-cell mediated anti-tumor immune responses.[1][2]
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 established
Diseases for which it is used
History of changes in FDA indication
- 2022-10-21: Approved in combination with durvalumab for adult patients with unresectable hepatocellular carcinoma (uHCC). (Based on HIMALAYA)
- 2022-11-10: Approved in combination with durvalumab and platinum-based chemotherapy for adult patients with metastatic non-small cell lung cancer (NSCLC) with no sensitizing epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. (Based on POSEIDON)
History of changes in EMA indication
- 2023-02-20: Initial authorisation as Imjudo in combination with durvalumab is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (HCC).
- 2023-04-04: Tremelimumab AstraZeneca in combination with durvalumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic non-small cell lung cancer (NSCLC) with no sensitising EGFR mutations or ALK positive mutations.
History of changes in PMDA indication
- 2022-12-23: Initial approval
Also known as
- Code name: CP-675, CP-675206
- Generic name: ticilimumab
- Brand name: Imjudo