Taiho Pharmaceutical Co., Ltd. today announced that Taiho Pharma Europe Ltd., a subsidiary of Taiho Pharmaceutical, has submitted on February 27, 2015 a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for TAS-102 (nonproprietary names: trifluridine and tipiracil hydrochloride), an oral combination anti-cancer drug intended for use in the treatment of refractory metastatic colorectal cancer (mCRC).
This MAA submission closely follows the TAS-102 New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA), which was accepted for review by the FDA on February 17, 2015. TAS-102 was approved initially in Japan in March 2014 and launched in May 2014 under the brand name "Lonsurf® combination tablet T15, T20".
For more details, go to: http://www.taiho.co.jp/english/news/20150302.html