Lonsurf trifluridine/tipiracil regulatory update

FDA approved an NDA from Taiho for Lonsurf trifluridine/tipiracil to treat refractory metastatic colorectal cancer (mCRC). Lonsurf is indicated in patients who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy and, if Ras wild-type, an anti- EGFR therapy. Taiho plans to make the drug available in the U.S. this month, at which time it will announce the price. The product is an oral combination of trifluridine (FTD), an antineoplastic nucleoside analog, and tipiracil, an inhibitor of the FTD-degrading enzyme thymidine phosphorylase. The NDA was approved ahead of its Dec. 19 PDUFA date. ...