BRIEF—Priority review status for trifluridine and tipiracil for refractory mCRC in Canada

The Canadian subsidiary of Taiho Pharmaceutical, itself a part of Japan’s Otsuka Holdings, says that Health Canada has accepted for review Taiho's New Drug Submission (NDS) for trifluridine (FTD) and tipiracil (TPI), for the treatment of refractory metastatic colorectal cancer (mCRC).

Also it noted that the NDS has been granted Priority Review status. Health Canada's review of the NDS under Priority Review is expected to be completed in early 2018.

France’s Servier gained rights to Lonsurf (trifluridine–tipiracil hydrochloride) from Taiho in 2015 for the treatment of patients with metastatic colorectal cancer who have received previous treatment in Europe and some other territories, under a deal that involved an upfront payment of $130 million to the Japanese drugmaker.

The US Food and Drug Administration approved Taiho’s Lonsurf in September 2015.