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Torisel (Temsirolimus)
Temsirolimus is an inhibitor of mTOR, a protein that controls cell division.
Torisel is an intravenous drug developed by Pfizer Inc. for the treatment of advanced renal cell carcinoma. It works by inhibiting the mTOR pathway, which controls cell division. This leads to a G1 growth arrest in treated tumor cells. Torisel is a derivative and prodrug of sirolimus. It was approved by the FDA in May 2007 and the EMA in November 2007. Torisel's mechanism of action provides a novel approach to treating renal cell carcinoma. Its approval marked a significant development in the treatment of this disease.
At a glance
| Generic name | Temsirolimus |
|---|---|
| Sponsor | Pfizer |
| Drug class | temsirolimus |
| Target | Multidrug resistance protein 1 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2007 |
Mechanism of action
Temsirolimus works by binding to an intracellular protein called FKBP-12. This protein-drug complex then inhibits the activity of mTOR, which controls cell division. Inhibition of mTOR results in a G1 growth arrest in treated tumor cells. This means that the cancer cells are unable to divide and grow, leading to a reduction in tumor size.
Approved indications
- Advanced renal cell carcinoma
Common side effects
- Hypersensitivity/Infusion Reactions
- Hepatic Impairment
- Hyperglycemia/Glucose Intolerance
- Infections
- Interstitial Lung Disease
- Hyperlipidemia
- Bowel Perforation
- Renal Failure
- Wound Healing Complications
- Intracerebral Hemorrhage
- Rash
- Asthenia
Drug interactions
- rifampin
- ketoconazole
- ramipril and/or amlodipine
Key clinical trials
- A Phase 2, Baseline-Controlled Study Evaluating the Safety and Efficacy of PTX-022 (Sirolimus) Topical Gel 3.9% in the Treatment of Cutaneous Venous Malformations (PHASE2)
- Testing Lutetium Lu 177 Dotatate in Patients With Somatostatin Receptor Positive Advanced Bronchial Neuroendocrine Tumors (PHASE2)
- Comparing Retreatment of 177Lu-DOTATATE PRRT Versus the Usual Treatment in Patients With Metastatic Unresectable Gastroenteropancreatic Neuroendocrine Tumors, NET RETREAT Trial (PHASE2)
- Combination Chemotherapy With or Without Temsirolimus in Treating Patients With Intermediate Risk Rhabdomyosarcoma (PHASE3)
- SELVA: A Phase 3 Study Evaluating QTORIN 3.9% Rapamycin Anhydrous Gel in the Treatment of Microcystic Lymphatic Malformations (PHASE3)
- Risk-Based Therapy in Treating Younger Patients With Newly Diagnosed Liver Cancer (PHASE3)
- Immunotherapy in Combination With Prednisone and Sirolimus for Kidney Transplant Recipients With Unresectable or Metastatic Skin Cancer (PHASE1, PHASE2)
- A Phase II Study of Sunitinib or Temsirolimus in Patients With Advanced Rare Tumours (PHASE2)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Torisel CI brief — competitive landscape report
- Torisel updates RSS · CI watch RSS
- Pfizer portfolio CI