NDA 207981, held by Taiho Oncology. Tipiracil Hydrochloride; Trifluridine.
As of Nov 14, 2026, NDA 207981 (Lonsurf), held by Taiho Oncology, was first approved by FDA on Sep 22, 2015, with 8 approved supplements and 0 published complete response letters.
LONSURF is a combination of trifluridine, a nucleoside metabolic inhibitor, and tipiracil, a thymidine phosphorylase inhibitor, indicated for the treatment of adult patients with: metastatic colorectal cancer as a single agent or in combination with bevacizumab 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. metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy. 1.
| Aug 2, 2023 | Supplement 12Efficacy (new indication or use) · Priority review | Approved | |
| Feb 22, 2019 | Supplement 8Efficacy (new indication or use) · Priority review | Approved | |
| Sep 22, 2015 | Original applicationNew molecular entity, new combination · Standard review | Approved |
| LonsurfEQ 6.14MG BASE;15MG · tablet;oral | Tipiracil Hydrochloride; Trifluridine | RxReference drug |
| LonsurfEQ 8.19MG BASE;20MG · tablet;oral | Tipiracil Hydrochloride; Trifluridine | RxReference drug |
| Aug 2, 2023 | Supplement 12Efficacy (new indication or use) · Priority review | Approved | |
| Jan 1, 2020 | Supplement 9Labeling · Standard review | Approved | |
| Feb 22, 2019 | Supplement 8Efficacy (new indication or use) · Priority review | Approved | |
| Jun 29, 2017 | Supplement 6Labeling · Standard review | Approved | |
| Mar 30, 2017 | Supplement 4Labeling · Standard review | Approved | |
| Apr 5, 2016 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Nov 20, 2015 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Nov 13, 2015 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Sep 22, 2015 | Original applicationNew molecular entity, new combination · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
