Sutent® Approved by FDA for Treatment of Renal Cell Carcinoma and Gastrointestinal Stromal Tumor
In January 2006 the U.S. Food and Drug Administration (FDA) approved the use of Sutent (SU 11248, sunitinib malate) for the treatment of gastrointestinal stromal tumors (GIST) that had progressed after Gleevec® (imatinib) and for advanced renal cell carcinoma (RCC). A patient information sheet has been published on the FDA Web site.[1]
Sutent is an oral kinase inhibitor of fms-like tyrosine kinase 3 (Flt3), Kit, VEGF, and PDGF receptors that is currently in clinical trials for treatment of a variety of malignancies. It produces anti-cancer effects through targeted mechanisms that include anti-angiogenesis, as well as direct killing of the cancer cell. In phase I-II studies, Sutent demonstrated antitumor and antiangiogenic activity in renal cell carcinoma (RCC), as well as other solid tumors.
In one phase II study, Sutent was administered to 63 patients with measurable RCC, who had failed one prior cytokine therapy. Patients received 6-week cycles of Sutent, consisting of 50 mg daily for 4 weeks, followed by 2 weeks off treatment. The partial response (PR) rate was 40% with 27% having disease stabilization for 3 or more weeks. The median time to disease progression was 9 months. Of the patients who achieved PR, the median duration of response was 16.4 months. Fifteen of the 25 patients who responded have progressed, 2 discontinued and 8 remain on treatment for up to 2 years. This and other studies provided the data for FDA approval of Sutent for treatment of RCC.
The results of a recent randomized multicenter trial of Sutent for patients with GIST refractory to Gleevec was recently summarized in the April 2006 issue of The Lancet Oncology.[2] This data is also available on the Pfizer web site but is not yet available in a definitive published form.[3] This study included 212 patients with GIST who had failed Gleevec treatment. They were randomly allocated to Sutent or placebo. Time to progression in the placebo group was 6 weeks compared to 27 weeks in the Sutent group. There was also a 50% reduction in the risk of dying in the Sutent group. Approximately 4% of patients received Sutent due to intolerance to Gleevec, and they responded well, suggesting that Sutent would be a first line drug for GIST. A controlled trial of Gleevec vs Sutent as first line therapy in GIST may be indicated.
Related News:
Sunitinib Malate (SU11248) Promising for Metastatic Renal Cell Carcinoma (11/17/2005)
SU11248 is Effective in Gastrointestinal Stromal Tumors (2/23/2005)
Reference
[1] http://www.fda.gov/cder/drug/InfoSheets/patient/sunitinibPIS.htm
[2] Susman E. New drug increases survival in stomach cancer. The Lancet Oncology. 2006;7:286.
[3] Pfizer. Pfizer Cancer Drug Demonstrates Early Efficacy and Safety; Placebo Patients to Switch Immediately to Drug Therapy. Available at: http://www.pfizer.com/are/investors_releases/2005pr/mn_2005_0208.cfm. Accessed February 2005.
© 1998-2007 OncoEd.com All Rights Reserved.
These materials may discuss uses and dosages for therapeutic products that have not been approved by the United States Food and Drug Administration. All readers should verify all information and data before administering any drug, therapy or treatment discussed herein. Neither the editors nor the publisher accepts any responsibility for the accuracy of the information or consequences from the use or misuse of the information contained herein.
Patient Home
