Fruquintinib is approved by the USFDA in refractory metastatic colorectal cancer

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.

The effectiveness 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 FRESCO-2 study was 7.4 months (95% CI: 6.7, 8.2) for patients who received fruquintinib and 4.8 months (95% CI: 4.0, 5.8) for those 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. In the FRESCO study, the median overall survival was 9.3 months (95% CI: 8.2–10.5) for the first therapy group and 6.6 months (95% CI: 5.9–8.1) for the second. The hazard ratio was 0.65 (95% CI: 0.51, 0.83) and the p-value was 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.