Temsirolimus
Temsirolimus (Torisel, Pfizer Europe MA EEIG) has 2 EU-approved indications in 2 tumour types.
| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Renal cell carcinoma1 | |||
None | Monotherapy | 1L advanced | At least three of six prognostic risk factors |
| Mantle cell lymphoma1 | |||
None | Monotherapy | 2L | Relapsed and/or refractory |
Full text of section 4.1 (therapeutic indications)
Renal cell carcinoma 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). Mantle cell lymphoma Torisel is indicated for the treatment of adult patients with relapsed and/or refractory mantle cell lymphoma (MCL) (see section 5.1).
Label history
1 change to the Torisel label since 2025, none of them to the indications. Newest first, in the words of EMA's record of each procedure.
Changes