FDA Approves Fruquintinib for Metastatic Colorectal Cancer with Prior Treatment History

By: Dr. Anish Shah
Bronx-Lebanon Hospital; Bronx, NY


On November 8, 2023, the U.S. Food and Drug Administration granted approval to Fruquintinib (Fruzaqla, Takeda Pharmaceuticals, Inc.) for adult patients who have metastatic colorectal cancer (mCRC). These patients must have previously undergone fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and if RAS wild-type and medically appropriate, an anti-EGFR therapy.


Study ID: NCT04322539 and NCT02314819


Approval was based on FRESCO-2 and FRESCO studies. FRESCO-2, an international, multicenter, randomized, double-blind, placebo-controlled trial, included 691 patients with mCRC. FRESCO, a
multicenter, placebo-controlled trial conducted in China, included 416 patients with mCRC. The patients were given Fruquintinib 5 mg orally once daily until disease progression or unacceptable toxicity. The median treatment duration was 21 days of each 28-day cycle.


Efficacy was established on overall survival (OS) as the major efficacy outcome in both trials. In FRESCO-2, the median OS was 7.4 months (95% CI: 6.7, 8.2) for those treated with fruquintinib and 4.8 months (95% CI: 4.0, 5.8) in the placebo group (HR 0.66 [95% CI: 0.55, 0.80] p-value < 0.001). In FRESCO, the median OS was 9.3 months (95% CI: 8.2, 10.5) and 6.6 months (95% CI: 5.9, 8.1) in the respective treatment arms (HR 0.65 [95% CI: 0.51, 0.83] p-value < 0.001).


The most common adverse reactions associated with Fruquintinib were hypertension, palmar-plantar erythrodysesthesia, proteinuria, dysphonia, abdominal pain, diarrhea, and asthenia.


The FDA has approved Fruquintinib for adult patients with mCRC who had received prior treatments. The approved dose is 5 mg orally once daily for the first 21 days of each 28-day cycle until disease progression or unacceptable toxicity.


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