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FDA grants fast track designation to TAS-102 for mCRC
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The FDA granted fast track designation to an investigational drug combination as a potential treatment for patients with refractory metastatic colorectal cancer, the drug’s manufacturer announced.
TAS-102 (Taiho Oncology) is an oral combination of trifluridine and tipiracil hydrochloride.
“We are pleased that TAS-102 has been granted fast track designation” Fabio M. Benedetti, MD, senior vice president and chief medical officer at Taiho Oncology, said in a press release. “Patients with metastatic colorectal cancer (mCRC), whose disease has progressed after treatment with standard therapies, have limited treatment options to manage their disease. We have initiated our rolling [new drug application] submission to the FDA and are committed to submitting the rest of the filing as efficiently as possible.”
The FDA based its decision on results from the phase 3 RECOURSE trial, designed to establish the efficacy and tolerability of the drug combination and improve OS in 800 patients with refractory mCRC whose disease had progressed after or who were intolerant to standard therapies.