Novel Agent Granted Fast Track Designation for Refractory Metastatic Colorectal Cancer
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to TAS-102, a novel agent currently under investigation for the treatment of refractory metastatic colorectal cancer.
According to estimates from the American Cancer Society, more than 102,000 new cases of colon cancer and about 40,000 new cases of rectal cancer were diagnosed in the United States in 2013.2 Together, the diseases were responsible for over 50,000 deaths. There is, however, good news about colorectal cancer in the United States: death rates associated with the disease have dropped during the past 15 years, and advances continue to be made in screening, prevention, and treatment. Unfortunately many individuals will fail initial therapy and develop metastatic disease. Continued development of drugs to treat metastatic colon cancer is necessary to further improve outcomes.
The FDA established the Fast Track designation process to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions, and that demonstrate the potential to address unmet medical needs. Fast Track designated drugs are afforded a rolling review of their New Drug Application filing by the FDA.
Researchers recently reported that the new combination agent TAS-102 improves overall survival in patients whose metastatic colorectal cancer is refractory to standard therapies. These results were recently reported at the ESMO 16th World Congress on Gastrointestinal Cancer in Barcelona.1
TAS-102 is a novel anti-cancer agent consisting of trifluridine (FTD) and tipiracil hydrochloride (TPI). FTD is the active component of TAS-102 and is directly incorporated into cancer DNA, leading to DNA dysfunction. However, when FTD is taken orally it is largely degraded to an inactive form. TPI prevents the degradation of FTD. A previously reported phase II trial of TAS-102 found an overall survival benefit in Japanese patients with metastatic colorectal cancer refractory to treatment.
The current RECOURSE study was a global phase III trial conducted in 13 countries. Patients had metastatic colorectal cancer refractory to all standard therapies including with wild-type KRAS tumors. Patients were treated with TAS-102 (534 patients) or placebo (266 patients) and directly compared.
The researchers found that TAS-102 prolonged overall survival experiencing a median overall survival of 7.1 months for TAS-102 and 5.3 months for placebo. TAS-102 also improved progression-free survival and was well tolerated with the most common side-effect being neutropenia.
- Yoshino T, Mayer R, Falcone A, et al. Results of a multicenter, randomised, double-blind, phase III study of TAS-102 vs. placebo, with best supportive care (BSC), in patients with metastatic colorectal cancer (mCRC) refractory to standard therapies (RECOURSE). Ann Oncol 2014 Jun; 25(Suppl 2):1-117.
- Cancer Facts and Figures http://www.cancer.org/acs/groups/content/@epidemiologysurveilance/documents/document/acspc-036845.pdf Accessed March 2014.
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