FDA approves combination for metastatic colorectal cancer
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The FDA approved trifluridine and tipiracil with bevacizumab for patients with previously treated metastatic colorectal cancer.
The approval applies to use of the combination by patients who received prior fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy and — if RAS wild-type — an anti-EGFR therapy.
Trifluridine and tipiracil (Lonsurf; Taiho Oncology) is an oral agent that utilizes a dual mechanism of action to maintain clinical activity.
Trifluridine, an antineoplastic nucleoside analogue, interferes with DNA function. The blood concentration of trifluridine is maintained via tipiracil, an inhibitor of the trifluridine-degrading enzyme thymidine phosphorylase.
The FDA in 2015 approved trifluridine and tipiracil monotherapy for pretreated metastatic colorectal cancer.
The agency based the new indication on results of the randomized SUNLIGHT trial, which assessed trifluridine and tipiracil with or without bevacizumab (Avastin, Genentech) for patients with metastatic colorectal cancer who received a maximum two prior chemotherapy regimens and either experienced disease progression on or were intolerant to their last regimen.
OS and PFS served as the primary efficacy outcomes.
As Healio previously reported, results showed statistically significant improvements in PFS (median, 5.6 months vs. 2.4 months; HR = 0.44; 95% CI, 0.36-0.54) and OS (median, 10.8 months vs. 7.5 months; HR = 0.61; 95% CI, 0.49-0.77) among patients treated with trifluridine and tipiracil with bevacizumab.
The most common adverse events that occurred among at least 20% of patients treated with the combination included neutropenia, anemia, thrombocytopenia, fatigue, nausea, increased aspartate aminotransferase and alanine aminotransferase levels, increased alkaline phosphatase, decreased sodium, diarrhea, abdominal pain and decreased appetite.
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