Wyeth Pharmaceuticals, a division of Wyeth announced that the US Food and Drug Administration (FDA) has approved Torisel (temsirolimus) for patients with advanced renal cell carcinoma (RCC). Torisel is the first targeted renal cancer therapy proven to extend median overall survival versus interferon-alpha, an active comparator, in this patient population.
Renal cell carcinoma accounts for approximately 85 per cent of kidney cancers. The American Cancer Society estimates that 51,190 new cases of kidney cancer will be diagnosed this year, and more than 40 per cent of these patients are initially diagnosed with advanced disease. Torisel is the only marketed cancer therapy that specifically inhibits the mTOR (mammalian target of rapamycin) kinase, a key protein in cells that regulates cell proliferation, cell growth and cell survival. Wyeth anticipates that Torisel will be available to patients in July 2007.
As part of a post marketing commitment, Wyeth has agreed to submit two completed study reports and data sets: one on a thorough QT prolongation study and one on an ongoing hepatic impairment study.
"Advanced renal cell carcinoma can be a devastating diagnosis for patients and their families because the disease is very difficult to treat," says Gary Hudes, MD, director, Genitourinary Malignancies Programme, Fox Chase Cancer Centre, Philadelphia, and lead investigator of the phase III trial of Torisel 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, Torisel significantly increased median overall survival by 49 percent compared to interferon-alpha. Torisel also was associated with a statistically significant improvement over interferon-alpha in the secondary endpoint of progression-free survival. The combination of Torisel and interferon-alpha did not result in a significant increase in overall survival when compared with interferon-alpha alone.
"The approval of Torisel for the treatment of advanced renal cell carcinoma reinforces the potential of mTOR inhibition as a new approach in oncology. This milestone demonstrates Wyeth's commitment to developing innovative therapies for cancer. In addition to Torisel, we have five oncology treatments currently in human trials for various cancers, and we are dedicated to research into new therapies that have the potential to address unmet medical needs," says Robert R. Ruffolo, Ph.D., president, Wyeth Research.