- The combination of trifluridine and tipiracil, previously approved by the FDA for advanced colorectal cancer, has been approved for metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.
- The indication includes patients previously treated with ≥2 chemotherapy regimens that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy.
Why this matters
- There are few therapeutic options for these patients after failure of first-line therapy.
- The approval is based on results from the phase 3 TAGS trial, which randomly assigned 507 patients in 17 countries and 110 sites to receive either trifluridine/tipiracil or placebo.
- Survival was better in the treatment group (5.7 vs 3.6 months; HR, 0.69; 1-sided P=.00029; 2-sided P=.00058).
- 80% of patients in the treatment group experienced grade 3 or worse adverse events compared with 58% in the placebo group.
- Neutropenia occurred in 34% and anemia occurred in 19% of the treatment group.
- 43% of patients in the treatment group had a serious adverse event of any cause compared with 42% of the placebo group.
Prescribing information, click here.