FDA Approval Summary: Fruquintinib for the Treatment of Refractory Metastatic Colorectal Cancer

医学 伊立替康 奥沙利铂 临床终点 安慰剂 内科学 危险系数 结直肠癌 随机对照试验 无进展生存期 肿瘤科 贝伐单抗 耐火材料(行星科学) 化疗 外科 癌症 置信区间 病理 天体生物学 物理 替代医学
作者
Michael Fusco,Sandra J. Casak,Sirisha L. Mushti,Joyce Cheng,Brian J. Christmas,Matthew D. Thompson,Wentao Fu,Hezhen Wang,Miyoung Yoon,Yuching Yang,Jason N. Moore,Youwei Bi,Yang Nan,Craig E. Long,Doris Auth,Nam Atiqur Rahman,Shenghui Tang,Richard Pazdur,Lola A. Fashoyin-Aje,Paul G. Kluetz,Steven J. Lemery
出处
期刊:Clinical Cancer Research [American Association for Cancer Research]
卷期号:30 (15): 3100-3104
标识
DOI:10.1158/1078-0432.ccr-24-0281
摘要

Abstract On November 8, 2023, the FDA approved fruquintinib, an inhibitor of vascular endothelial growth factor receptor (VEGFR)-1, -2, and -3, for the treatment of patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and if RAS wild-type and medically appropriate, an anti-EGFR therapy. Approval was based on Study FRESCO-2, a globally conducted, double-blind, placebo-controlled randomized trial. The primary endpoint was overall survival (OS). The key secondary endpoint was progression-free survival. A total of 691 patients were randomly assigned (461 and 230 into the fruquintinib and placebo arms, respectively). Fruquintinib provided a statistically significant improvement in OS with a hazard ratio (HR) of 0.66 [95% confidence interval (CI), 0.55, 0.80; P < 0.001]. The median OS was 7.4 months (95% CI, 6.7, 8.2) in the fruquintinib arm and 4.8 months (95% CI, 4.0, 5.8) for the placebo arm. Adverse events observed were generally consistent with the known safety profile associated with the inhibition of VEGFR. The results of FRESCO-2 were supported by the FRESCO study, a double-blind, single-country, placebo-controlled, randomized trial in patients with refractory mCRC who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. In FRESCO, the OS HR was 0.65 (95% CI, 0.51, 0.83; P < 0.001). FDA concluded that the totality of the evidence from FRESCO-2 and FRESCO supported an indication for patients with mCRC with prior treatment with fluoropyrimidine, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type and medically appropriate, an anti-EGFR therapy.
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