Class/mechanism: mTOR (mammalian target of rapamycin) inhibitor. mTOR inhibition by temsirolimus interferes with the ability of mTOR to phosphorylate downstream targets in the PI3 kinase/AKT pathway, such as p70S6k and the S6 ribosomal protein. Temsirolimus has also been observed to reduce levels of VEGF (vascular endothelial growth factor) and hypoxia-inducible factors HIF-1 and HIF-2 alpha.
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 (work in progress)
Diseases for which it is used
Patient drug information
- Temsirolimus (Torisel) package insert
- Temsirolimus (Torisel) patient drug information (Chemocare)
- Temsirolimus (Torisel) patient drug information (UpToDate)
History of changes in FDA indication
- 2007-05-30: Initial FDA approval for the treatment of advanced renal cell carcinoma. (Based on ARCC)
History of changes in EMA indication
- 2007-11-19: Initial authorization as Torisel. Torisel is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC) who have at least three of six prognostic risk factors. (Based on ARCC)
- 2009-10-14: Extension of Indication to add treatment of adult patients with relapsed and/or refractory mantle cell lymphoma (MCL).
History of changes in Health Canada indication
- 2007-12-21: Initial notice of compliance
History of changes in PMDA indication
- 2010-07-23: Initial approval for the treatment of unresectable or metastatic renal cell carcinoma.
Also known as
- Code name: CCI-779
- Brand name: Torisel