# Temsirolimus

Temsirolimus (Torisel, Pfizer Europe MA EEIG) has 2 EU-approved indications in 2 tumour types.

## Approved indications

### Renal cell carcinoma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | Monotherapy | 1st line, advanced | At least three of six prognostic risk factors |

### Mantle cell lymphoma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | Monotherapy | 2nd line | Relapsed and/or refractory |

## Products

### Torisel

- Company: Pfizer Europe MA EEIG
- Target: mTOR inhibitor
- Class: Mammalian target of rapamycin (mTOR) kinase inhibitors
- ATC: L01EG01
- EU approval: 19 Nov 2007
- Label revised: 3 Mar 2025
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/torisel-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/torisel-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/torisel

Mechanism (SmPC section 5.1): Binds FKBP-12 to form a complex that inhibits mTOR, disrupting downstream translation of cell cycle regulatory proteins and impairing tumor vessel development.

## Label wording

- **Temsirolimus** (Torisel), Renal cell carcinoma, 1st line, advanced: “Torisel is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC) who have at least three of six prognostic risk factors (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/torisel-epar-product-information_en.pdf)
- **Temsirolimus** (Torisel), Mantle cell lymphoma, 2nd line: “Torisel is indicated for the treatment of adult patients with relapsed and/or refractory mantle cell lymphoma (MCL) (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/torisel-epar-product-information_en.pdf)

Source: section 4.1 of each summary of product characteristics (SmPC), EMA data as of 5 Nov 2026. AI models structured these entries and no person has checked them yet. oncolabels is a non-commercial reference for education and research and gives no medical advice; the current SmPC takes precedence.

Data under CC BY 4.0: credit oncolabels and the European Medicines Agency. Page: https://oncolabels.com/drugs/temsirolimus