Pharmacologic class:

Antineoplastic (mTOR kinase inhibitor)

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Active ingredient:

Temsirolimus 25 mg/mL; ethanolic solution for IV infusion after two dilutions (first with supplied diluent); contains alcohol, polysorbate 80.


Advanced renal cell carcinoma.


Temsirolimus binds to an intracellular protein, and the resulting protein-drug complex inhibits the activity of an intracellular target called “mTOR kinase,” a cellular enzyme that regulates cell proliferation, cell growth, and cell survival. In vitro studies have shown that inhibiting mTOR interferes with the translation of genes that regulate the cell cycle.

Interference also resulted in reduced levels of certain cell-growth factors involved in the development of new blood vessels, such as vascular endothelial growth factor. In a study conducted in 626 previously untreated patients with advanced renal cell carcinoma, treatment with temsirolimus was compared with temsirolimus + interferon-a and with interferon-a alone. There was a statistically significant improvement in overall survival in the patients given temsirolimus (10.9 months) compared with those given interferon-a (7.3 months).

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