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Clinical Trial
. 2010;15(4):428-35.
doi: 10.1634/theoncologist.2009-0178. Epub 2010 Mar 23.

FDA approval summary: temsirolimus as treatment for advanced renal cell carcinoma

Virginia E Kwitkowski  1 , Tatiana M Prowell, Amna Ibrahim, Ann T Farrell, Robert Justice, Shan Sun Mitchell, Rajeshwari Sridhara, Richard Pazdur
Affiliations
Clinical Trial

FDA approval summary: temsirolimus as treatment for advanced renal cell carcinoma

Virginia E Kwitkowski et al. Oncologist. 2010.

Abstract

This report summarizes the U.S. Food and Drug Administration (FDA)'s approval of temsirolimus (Torisel), on May 30, 2007, for the treatment of advanced renal cell carcinoma (RCC). Information provided includes regulatory history, study design, study results, and literature review. A multicenter, three-arm, randomized, open-label study was conducted in previously untreated patients with poor-prognosis, advanced RCC. The study objectives were to compare overall survival (OS), progression-free survival (PFS), objective response rate, and safety in patients receiving interferon (IFN)-alpha versus those receiving temsirolimus alone or in combination with IFN-alpha. In the second planned interim analysis of the intent-to-treat population (n = 626), there was a statistically significant longer OS time in the temsirolimus (25 mg) arm than in the IFN-alpha arm (median, 10.9 months versus 7.3 months; hazard ratio [HR], 0.73; p = .0078). The combination of temsirolimus (15 mg) and IFN-alpha did not lead to a significant difference in OS compared with IFN-alpha alone. There was also a statistically significant longer PFS time for the temsirolimus (25 mg) arm than for the IFN-alpha arm (median, 5.5 months versus 3.1 months; HR, 0.66, p = .0001). Common adverse reactions reported in patients receiving temsirolimus were rash, asthenia, and mucositis. Common laboratory abnormalities were anemia, hyperglycemia, hyperlipidemia, and hypertriglyceridemia. Serious but rare cases of interstitial lung disease, bowel perforation, and acute renal failure were observed. Temsirolimus has demonstrated superiority in terms of OS and PFS over IFN-alpha and provides an additional treatment option for patients with advanced RCC.

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Conflict of interest statement

Disclosures

Virginia E. Kwitkowski: None; Tatiana M. Prowell: None; Amna Ibrahim: None; Ann T. Farrell: None; Robert Justice: None; Shan Sun Mitchell: None; Rajeshwari Sridhara: None; Richard Pazdur: None.

Section editor Martin Cohen has disclsoed no financial relationships relevant to the content of this article

The content of this article has been reviewed by independent peer reviewers to ensure that it is balanced, objective, and free from commercial bias.

Figures

Figure 1.
Figure 1.
Chemical structure of temsirolimus. Molecular weight, 1030.3; molecular formula, C56H87NO16.
Figure 2.
Figure 2.
Phase III temsirolimus trial design. Abbreviations: IFN, interferon; Q, every; s.c., subcutaneous.
Figure 3.
Figure 3.
Overall survival in intent-to treat population.
See this image and copyright information in PMC

Comment in

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