FDA fast-tracks Taiho Oncology’s TAS-102 for colorectal cancer

The US Food and Drug Administration has granted Fast Track designation for TAS-102 (trifluridine and tipiracil hydrochloride), an oral combination anticancer drug under investigation by Taiho Oncology, a unit of Japanese drugmaker Otsuka (TYO: 4768).

The New Drug Application is for the treatment of refractory metastatic colorectal cancer (mCRC), and the company has initiated a rolling NDA submission to the FDA. According to the American Cancer Society, an estimated 136,830 people will be diagnosed with, and 50,310 people will die from, cancer of the colon or rectum during 2014 in the USA.

"We are pleased that TAS-102 has been granted Fast Track designation," said Fabio Benedetti, senior vice president and chief medical officer at Taiho Oncology, adding: "Patients with metastatic colorectal cancer, whose disease has progressed after treatment with standard therapies, have limited treatment options to manage their disease. We have initiated our rolling NDA submission to the FDA, and are committed to submitting the rest of the filing as efficiently as possible."