Difference between revisions of "Lurbinectedin (Zepzelca)"
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==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | * | + | *2020-06-15: [https://www.fda.gov/drugs/drug-approvals-and-databases/fda-grants-accelerated-approval-lurbinectedin-metastatic-small-cell-lung-cancer Accelerated FDA approval] for adult patients with metastatic [[Small cell lung cancer|small cell lung cancer (SCLC)]] with disease progression on or after [[:Category:Platinum agents|platinum-based chemotherapy]]. ''(Based on PM1183-B-005-14)'' |
| + | ==History of changes in Health Canada indication== | ||
| + | *2021-09-29: Initial notice of compliance with conditions for the treatment of adults with Stage III or metastatic [[Small cell lung cancer|small cell lung cancer (SCLC)]] who have progressed on or after platinum-containing therapy. | ||
==Also known as== | ==Also known as== | ||
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[[Category:FDA approved in 2020]] | [[Category:FDA approved in 2020]] | ||
| + | [[Category:Health Canada approved in 2021]] | ||
Revision as of 12:31, 31 March 2023
General information
Class/mechanism: Alkylator, binds to the minor groove of DNA, which distorts the DNA helix toward the major groove. This binding interrupts normal cell function and interferes with the expression of several several transcription factors, DNA binding proteins, and DNA repair mechanisms, which interrupts cell cycle and leads to tumor death.[1][2][3]
Route: IV
Extravasation: no information to cite, but suspected vesicant due to its similarity to Trabectedin (Yondelis)
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.[1]
Diseases for which it is used
Patient drug information
- Lurbinectedin (Zepzelca) package insert[1]
- Lurbinectedin (Zepzelca) patient drug information (UpToDate)[4]
History of changes in FDA indication
- 2020-06-15: Accelerated FDA approval for adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy. (Based on PM1183-B-005-14)
History of changes in Health Canada indication
- 2021-09-29: Initial notice of compliance with conditions for the treatment of adults with Stage III or metastatic small cell lung cancer (SCLC) who have progressed on or after platinum-containing therapy.
Also known as
- Code name: PM-01183
- Brand name: Zepzelca