Josep Tabernero, MD, PhD The European Commission (EC) has approved fruquintinib (Fruzaqla) monotherapy for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with available standard therapies, including fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, anti-VEGF agents, and anti-EGFR agents, and who have progressed on or are intolerant to treatment with either trifluridine plus tipiracil (TAS-102; Lonsurf) or regorafenib (Stivarga). 1 The regulatory decision was supported by data from the phase 3 FRESCO-2 trial (NCT04322539), which showed that treatment with fruquintinib led to a statistically significant and clinically meaningful improvement in overall survival (OS) compared with placebo in patients with refractory mCRC (HR, 0.66; 95% CI, 0.
55-0.80; P < .0001).
2 At a median follow-up of 11.3 months (interquartile range [IQR], 9.0-14.
2) in the fruquintinib group and 11.2 months (IQR, 8.7-15.
5) in the placebo group, fruquintinib (n = 461) elicited a median OS of 7.4 months (95% CI, 6.7-8.
2) vs 4.8 months (95% CI, 4.0-5.
8) for placebo (n = 230). “With fruquintinib being the first and only selective inhibitor of all three VEGFRs to be approved in the European Union for CRC, this decision represents a significant milestone in European oncology,” Josep Tabernero, MD, PhD, director of Vall d ́Hebron Institute of Oncology, stated in a news release. 1 “There is a clear need in Europe for patients and the.
