Fruquintinib is approved by the USFDA in refractory metastatic colorectal cancer

Fruquintinib is approved by the USFDA in refractory metastatic colorectal cancer

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The Food and Drug Administration approved fruquintinib (Fruzaqla, Takeda Pharmaceuticals, Inc.) on November 8, 2023, for adult patients with metastatic colorectal cancer (mCRC) who have undergone specific prior treatments.

Efficacy was assessed in FRESCO-2 (NCT04322539) and FRESCO (NCT02314819). The FRESCO-2 trial (NCT04322539) assessed 691 patients with mCRC who experienced disease progression after previous fluoropyrimidine-, oxaliplatin-, irinotecan-based chemotherapy, anti-VEGF biological therapy, anti-EGFR biological therapy (if RAS wild type), and at least one of trifluridine/tipiracil or regorafenib. It was an international, multicenter, randomized, double-blind, placebo-controlled study. The FRESCO trial, a multicenter study in China, assessed 416 patients with metastatic colorectal cancer who experienced disease progression following previous fluoropyrimidine-, oxaliplatin, and irinotecan-based chemotherapy.

In both trials, patients were randomly assigned to either get fruquintinib 5 mg orally once a day or a placebo for the first 21 days of each 28-day cycle. They also got the best possible supportive care. Patients were treated until disease progression or unacceptable toxicity occurred.

The primary effectiveness outcome in both trials was overall survival (OS). The median overall survival in the fruquintinib group was 7.4 months (95% CI: 6.7, 8.2) compared to 4.8 months (95% CI: 4.0, 5.8) in the placebo group. The hazard ratio was 0.66 (95% CI: 0.55, 0.80) with a p-value of less than 0.001. The median overall survival (OS) in the FRESCO study was 9.3 months (95% CI: 8.2, 10.5) and 6.6 months (95% CI: 5.9, 8.1) in the different treatment groups. The hazard ratio (HR) was 0.65 (95% CI: 0.51, 0.83) with a statistically significant p-value of less than 0.001.

The prevalent side effects (experienced by 20% or more of patients) included hypertension, palmar-plantar erythrodysesthesia, proteinuria, dysphonia, abdominal pain, diarrhea, and asthenia.

The suggested fruquintinib dosage is 5 mg taken orally once a day, with or without food, for the initial 21 days of a 28-day cycle until disease progression or intolerable toxicity.

View full prescribing information for fruquintinib.

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