Taiho Oncology, Inc., a subsidiary of Taiho Pharmaceutical Co., Ltd. (Japan), today announced the New Drug Application (NDA) for TAS-102 (nonproprietary names: trifluridine and tipiracil hydrochloride), has been accepted for review by the U.S. Food and Drug Administration (FDA). TAS-102 is an oral combination investigational anticancer drug for the treatment of refractory metastatic colorectal cancer (mCRC).
"The FDA's filing of the TAS-102 NDA represents a significant milestone for our company and underscores the need for new treatment options for patients with refractory metastatic colorectal cancer," said Eric Benn, Taiho Oncology's president and chief executive officer. "Today, we are one step closer to our ultimate goal of gaining regulatory approval for TAS-102 and making it available to patients in the USA with this serious medical condition. We look forward to working closely with the FDA during the NDA review."
Taiho Oncology submitted the final portion of the rolling NDA for U.S. marketing approval of TAS-102 on December 19, 2014. The PDUFA goal date is December 19, 2015.
"Metastatic colorectal cancer persists as one of the foremost common cancers among men and women," said Robert J. Mayer, MD, a principal investigator of the RECOURSE study and Faculty Vice President for Academic Affairs at the Dana Farber Cancer Institute and Professor of Medicine at Harvard Medical School. "If approved, TAS-102 has the potential to become an important new treatment option for patients in the U.S. who are living with refractory metastatic colorectal cancer."
Results from the Phase III RECOURSE trial of TAS-102 in 800 mCRC patients, whose disease had progressed after or who were intolerant to standard therapies, form the foundation for the NDA. The TAS-102 RECOURSE trial met the primary efficacy endpoint of statistically significant improvement in overall survival versus placebo (HR = 0.68, p < 0.0001) and demonstrated a safety profile consistent with that observed in earlier clinical trials.