FDA OKs Trifluridine/Tipiracil Plus Bevacizumab for mCRC

M. Alexander Otto, PA, MMS

August 02, 2023

The US Food and Drug Administration (FDA) has approved the use of trifluridine and tipiracil (Lonsurf, Taiho Oncology) along with bevacizumab for patients with metastatic colorectal cancer (CRC) who have previously undergone treatment with fluoropyrimidine, oxaliplatin, and irinotecan-based chemotherapy as well as an anti-VEGF biological therapy and an anti-EGFR if tumors are RAS wild-type.

The FDA previously approved trifluridine/tipiracil as monotherapy for this indication in 2015, according to the agency's press release announcing the new indication. Trifluridine/tipiracil also carries an indication for previously treated metastatic gastric or gastroesophageal junction adenocarcinoma after at least two lines of treatment.

Approval for combining trifluridine/tipiracil with bevacizumab was based on the SUNLIGHT trial, which pitted the combination against trifluridine/tipiracil monotherapy in 492 patients with metastatic CRC who had experienced disease progression after no more than two prior chemotherapy regimens or who were intolerant of their last regimen.

Among the patients who received bevacizumab as add-on therapy, the median overall survival was 10.8 months, vs 7.5 months among those who received trifluridine/tipiracil alone. Median progression-free survival was 5.6 months in the combination arm, vs 2.4 months without bevacizumab.

"Trifluridine/tipiracil plus bevacizumab may represent a meaningful new treatment option in patients with mCRC who have progressed after two lines of therapy," the trial's senior investigator, Josep Tabernero, MD, PhD, of Vall d'Hebron University Hospital in Barcelona, said in a May press release announcing publication of the SUNLIGHT results.

The most common adverse events or laboratory abnormalities with trifluridine/tipiracil plus bevacizumab that occurred in 20% or more of patients are neutropenia, anemia, thrombocytopenia, fatigue, nausea, increased AST, increased ALT, increased alkaline phosphatase, decreased sodium, diarrhea, abdominal pain, and decreased appetite.

The recommended dosgee of trifluridine/tipiracil is 35 mg/m2 orally twice daily with food on days 1 through 5 and days 8 through 12 of each 28-day cycle.

Twenty tablets of 6.14 mg/15 mg cost around $4204, according to drugs.com.

M. Alexander Otto is a physician assistant with a master's degree in medical science and a journalism degree from Newhouse. He is an award-winning medical journalist who worked for several major news outlets before joining Medscape. Alex is also an MIT Knight Science Journalism fellow. Email: aotto@mdedge.com.

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