FDA Approves Temsirolimus for the Treatment of Advanced Kidney Cancer

Wyeth Pharmaceuticals recently announced that the US Food and Drug Administration (FDA) has approved temsirolimus (Torisel) for patients with advanced renal cell carcinoma (RCC). Temsirolimus is the first targeted renal cancer therapy proven to extend median overall survival vs interferon-alpha, an active comparator, in this patient population.

Temsirolimus is the only marketed cancer therapy that specifically inhibits the mammalian target of rapamycin (mTOR) kinase, a key protein in cells that regulates cell proliferation, cell growth and cell survival. Wyeth anticipates that temsirolimus will be available to patients in July 2007.

Devastating Diagnosis

"Advanced renal cell carcinoma can be a devastating diagnosis for patients and their families because the disease is very difficult to treat," said Gary Hudes, md, director, genitourinary malignancies program, Fox Chase Cancer Center, Philadelphia, and lead investigator of the phase III trial of temsirolimus in advanced RCC. "Developing effective treatments for this stage of disease is a major challenge. Temsirolimus is the first drug to demonstrate a significant increase in overall survival for patients with the most aggressive form of kidney cancer, providing us with a new and much needed option for treatment."

In a three-arm, phase III clinical trial of 626 patients with advanced RCC and poor prognosis who had received no prior systemic therapy, temsirolimus significantly increased median overall survival by 49% compared to interferon-alpha (10.9 vs 7.3 months, P = .0078).Temsirolimus also was associated with a statistically significant improvement over interferon-alpha in the secondary endpoint of progression-free survival (5.5 vs 3.1 months, P = .0001). The combination of temsirolimus and interferon-alpha did not result in a significant increase in overall survival when compared with interferon-alpha alone.