FDA Approves TORISEL, a Targeted First-in-Class mTOR Inhibitor for the Treatment of Advanced Kidney Cancer

04-Jun-2007

Wyeth Pharmaceuticals, a division of Wyeth, announced that the U.S. Food and Drug Administration (FDA) has approved TORISEL(TM) (temsirolimus) for patients with advanced renal cell carcinoma (RCC). According to the company, TORISEL is the first targeted renal cancer therapy proven to extend median overall survival versus interferon-alpha, an active comparator, in this patient population.

As part of a postmarketing 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.

In a three-arm, phase 3 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 (10.9 months vs. 7.3 months, P=0.0078). TORISEL also was associated with a statistically significant improvement over interferon-alpha in the secondary endpoint of progression-free survival (when the disease does not get worse; 5.5 months vs. 3.1 months, P=0.0001). The combination of TORISEL and interferon-alpha did not result in a significant increase in overall survival when compared with interferon-alpha alone.

TORISEL is an mTOR inhibitor indicated for the treatment of advanced RCC. In in vitro studies using cancer cells, mTOR inhibition blocked the translation of genes that regulate the cell cycle. mTOR inhibition also resulted in reduced levels of certain cell growth factors involved in the development of new blood vessels, such as vascular endothelial growth factor.

https://www.bionity.com/en/news/65029/fda-approves-torisel-a-targeted-first-in-class-mtor-inhibitor-for-the-treatment-of-advanced-kidney-cancer.html