What cancers is temsirolimus approved for?

It is approved for advanced renal cell carcinoma and, in the EU, for relapsed or refractory mantle cell lymphoma.

How does temsirolimus relate to sirolimus and everolimus?

Temsirolimus is a prodrug that is converted to sirolimus (rapamycin), and like everolimus it inhibits the mTOR pathway; the main practical difference is that temsirolimus is intravenous whereas everolimus is oral.

Why is premedication needed?

Infusion-related hypersensitivity reactions can occur, so an antihistamine is usually given beforehand and patients are monitored during the infusion.

Does temsirolimus affect metabolism?

Yes; hyperglycaemia, raised lipids and low phosphate are recognised effects, so blood tests are monitored during treatment.

EMA-approved

Temsirolimus — Complete Research Guide (2026)

Last updated 2026-06-30

TL;DR

Temsirolimus is a peptide catalogued under Cyclic & Antimicrobial. Neutral reference entry; EU status: EU-approved prescription medicine.

What is Temsirolimus?

Temsirolimus (Torisel) is an intravenously administered mTOR inhibitor that acts as an ester prodrug of sirolimus (rapamycin).

It received FDA approval in 2007 and EMA approval for advanced renal cell carcinoma, and is additionally EMA-approved for relapsed or refractory mantle cell lymphoma.

Its efficacy rests on randomised phase 3 trials (Hudes 2007 in RCC and Hess 2009 in mantle cell lymphoma).

How does Temsirolimus work?

Temsirolimus (and its active metabolite sirolimus) binds FKBP-12 to inhibit mTOR complex 1, suppressing tumour-cell proliferation and HIF/VEGF-driven angiogenesis.

This mTOR blockade halts cells in the G1 phase and reduces synthesis of proteins that promote cancer growth and blood-vessel formation.

What does the research say about Temsirolimus?

In previously untreated poor-prognosis advanced renal cell carcinoma, single-agent temsirolimus improved overall survival compared with interferon alfa. ^[1]
In relapsed or refractory mantle cell lymphoma, temsirolimus improved progression-free survival versus investigator's choice of therapy. ^[2]
As second-line therapy after sunitinib in metastatic RCC, temsirolimus did NOT improve overall survival versus sorafenib (INTORSECT) - a candid negative result. ^[3]

Clinical research & studies

The references below are the primary sources cited throughout this guide. Each links directly to PubMed or the regulator. Where evidence is preclinical (animal or in-vitro), that is stated rather than implied.

[1] Temsirolimus, interferon alfa, or both for advanced renal-cell carcinoma — Hudes G et al., The New England Journal of Medicine 2007. (Randomised phase 3 trial)
[2] Phase III study to evaluate temsirolimus compared with investigator's choice therapy for the treatment of relapsed or refractory mantle cell lymphoma — Hess G et al., Journal of Clinical Oncology 2009. (Randomised phase 3 trial)
[3] Randomized phase III trial of temsirolimus versus sorafenib as second-line therapy after sunitinib in patients with metastatic renal cell carcinoma — Hutson TE et al., Journal of Clinical Oncology 2014. (Randomised phase 3 trial (INTORSECT))
[4] Clinical experience with temsirolimus in the treatment of advanced renal cell carcinoma — Zanardi E et al., Therapeutic Advances in Urology 2015. (Narrative review)
[5] Temsirolimus — Schulze M et al., Recent Results in Cancer Research 2014. (Drug review/monograph)

Dosing context

This is not medical advice or a usage recommendation. Dosing figures are reported research context only, cited from the published literature.

Dosing is context-only: temsirolimus is given as a weekly intravenous infusion by oncology teams, with premedication, and the schedules used for renal cell carcinoma and mantle cell lymphoma differ.

It is not an oral, self-administered, or research-use product and requires supervised administration and monitoring.

Side effects & safety profile

As an mTOR inhibitor, temsirolimus shares the class risk of immunosuppression with serious infections plus metabolic effects such as hyperglycaemia, hyperlipidaemia and hypophosphataemia.

Because it is infused, hypersensitivity/infusion reactions are a specific concern and antihistamine premedication is recommended.

Other common effects include rash, mucositis/stomatitis, asthenia, cytopenias, and non-infectious interstitial lung disease.

Stacking & combinations

Temsirolimus is a specialist-administered oncology infusion used as monotherapy or per clinical-trial protocol, not a discretionary stack component.

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Frequently asked questions

It is administered as an intravenous infusion, typically weekly, in an oncology setting with antihistamine premedication to reduce infusion reactions.

References

[1] Temsirolimus, interferon alfa, or both for advanced renal-cell carcinoma — Hudes G et al., The New England Journal of Medicine 2007. PMID: 17538086. View sourceStudy: Randomised phase 3 trialTemsirolimus improved overall survival versus interferon alfa in poor-prognosis advanced RCC.
[2] Phase III study to evaluate temsirolimus compared with investigator's choice therapy for the treatment of relapsed or refractory mantle cell lymphoma — Hess G et al., Journal of Clinical Oncology 2009. PMID: 19581539. View sourceStudy: Randomised phase 3 trialTemsirolimus significantly improved progression-free survival versus investigator's choice in relapsed/refractory mantle cell lymphoma.
[3] Randomized phase III trial of temsirolimus versus sorafenib as second-line therapy after sunitinib in patients with metastatic renal cell carcinoma — Hutson TE et al., Journal of Clinical Oncology 2014. PMID: 24297950. View sourceStudy: Randomised phase 3 trial (INTORSECT)Temsirolimus did not improve overall survival versus sorafenib as second-line therapy after sunitinib.
[4] Clinical experience with temsirolimus in the treatment of advanced renal cell carcinoma — Zanardi E et al., Therapeutic Advances in Urology 2015. PMID: 26161146. View sourceStudy: Narrative reviewReviews the efficacy, positioning and toxicity profile of temsirolimus in advanced renal cell carcinoma.
[5] Temsirolimus — Schulze M et al., Recent Results in Cancer Research 2014. PMID: 24756806. View sourceStudy: Drug review/monographSummarises the pharmacology, clinical development and adverse-effect profile of temsirolimus as an mTOR inhibitor.

This article is for educational and research purposes only. Peptides discussed here are not approved for human consumption by the FDA, EMA, or equivalent regulators outside of specific clinical contexts. Always consult a licensed medical professional before any therapeutic use.