FDA Approves Torisel™ For Kidney Cancer

FDA Approves Torisel™ For Kidney Cancer

The United States Food and Drug Administration (FDA) recently approved the mTOR inhibitor ToriselTM (temsirolimus) for the treatment of advanced kidney cancer.

The kidneys are each filled with tiny tubules that clean and filter the blood-the process that removes waste and makes urine. Renal cell cancer (RCC) is a malignancy involving these tubules of the kidney. Metastatic RCC refers to cancer that has spread from the kidney to distant sites in the body. Metastatic RCC is often treated with cytokines, or immune stimulating agents, such as interferon. These cytokines, however, are associated with significant side effects resulting in a poor quality of life for patients during treatment. For patients with very advanced disease, cytokines provide a median survival of only four to eight months.

In order to improve survival and quality of life for patients with metastatic RCC, researchers continue to evaluate novel therapeutic strategies. Targeted agents are becoming a strong focus of such research.

Torisel, referred to as an mTOR (mammalian target of rapamycin kinase), is one such targeted agent. It blocks the growth of cancer cells by inhibiting specific biological pathways that are involved in cellular replication and spread.

The clinical trial that prompted FDA approval of Torisel included 626 patients with metastatic RCC who had a poor prognosis and had not received prior therapy. Patients were treated with either Torisel, interferon alfa, or a combination of Torisel plus interferon alfa (combination group).

  • Patients treated with Torisel had longer survival by nearly 3.6 months and significantly longer progression-free survival than patients treated with interferon alone.
  • Patients in the combination group did not experience a significant improvement in survival compared with patients treated with interferon alone.
  • Fewer patients suffered from severe side effects in the group treated with Torisel than in the group treated with interferon.

The researchers concluded, “As compared with interferon alfa, temsirolimus improved overall survival among patients with metastatic renal-cell carcinoma and a poor prognosis. The addition of temsirolimus to interferon did not improve survival.” Torisel is the first targeted agent to demonstrate an improvement in survival thus far in the treatment of metastatic RCC. Patients with advanced RCC may wish to speak with their physician regarding their individual risks and benefits of treatment including Torisel.

Reference: Hudes G, Carducci M, Tomczak P, et al. Temsirolimus, interferon alfa, or both for advanced renal cell carcinoma. New England Journal of Medicine. 2007; 356:2271-2281.

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