FDA Grants Approval to Fruquintinib for Patients With Refractory Metastatic Colorectal Cancer
On November 8, 2023, the US Food and Drug Administration (FDA) approved fruquintinib for patients with metastatic colorectal cancer who had previously been treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if appropriate, an anti-EGFR therapy.
This decision was based on the results from the FRESCO-2 and FRESCO phase 3 trials. The international, multicenter, double-blind FRESCO-2 trial enrolled 961 patients with metastatic colorectal cancer who had been treated with prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if appropriate, an anti-EGFR therapy, and either trifluridine/tipiracil or regorafenib. The multicenter FRESCO trial enrolled 416 patients in China with metastatic colorectal cancer who had previously been treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.
In both trials, patients were randomized on a 2-to-1 basis to receive either 5 mg fruquintinib once daily or placebo for the first 21 days of each 28-day cycle, plus best supportive care until disease progression or unacceptable toxicity. The main efficacy outcome in both trials was overall survival (OS).
In FRESCO-2, the median OS was 7.4 months in the fruquintinib arm vs 4.8 months in the placebo arm (hazard ratio [HR], 0.66; 95% confidence interval [CI], 0.55 to 0.80; P < 001). In FRESCO, the median OS was 9.3 months vs 6.6 months, respectively (HR, 0.65; 95% CI, 0.51 to 0.83; P < .001). The most common adverse events, occurring in ≥20% of patients, were hypertension, palmar-plantar erythrodysesthesia, proteinuria, dysphonia, abdominal pain, diarrhea, and asthenia.
Source:
FDA approves fruquintinib in refractory metastatic colorectal cancer. US Food and Drug Administration. Published November 9, 2023. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-fruquintinib-refractory-metastatic-colorectal-cancer
