FDA approves fruquintinib in refractory metastatic colorectal cancer
Regulatory approval: On Nov 8, 2023, the FDA approved fruquintinib (Fruzaqla; Takeda) for adults with metastatic colorectal cancer 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 supported by OS results from the randomized, placebo-controlled FRESCO-2 and FRESCO trials. Common adverse reactions included hypertension and palmar-plantar erythrodysesthesia.
FDA approval (Nov 8, 2023): fruquintinib for refractory mCRC
The US FDA approved fruquintinib (Fruzaqla; Takeda Pharmaceuticals, Inc.) on 2023-11-08 for adult patients with metastatic colorectal cancer (mCRC) who previously received fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and if RAS wild-type and medically appropriate, an anti-EGFR therapy.
Supporting evidence
Efficacy was evaluated in FRESCO-2 (NCT04322539) and FRESCO (NCT02314819). In both trials, patients were randomized 2:1 to fruquintinib 5 mg orally once daily vs placebo for the first 21 days of each 28-day cycle, plus best supportive care, until progression or unacceptable toxicity. Overall survival (OS) was the major endpoint.
- FRESCO-2 (n=691; international, randomized, double-blind, placebo-controlled): median OS 7.4 vs 4.8 months (HR 0.66, 95% CI 0.55–0.80; p<0.001).
- FRESCO (n=416; China, multicenter, placebo-controlled): median OS 9.3 vs 6.6 months (HR 0.65, 95% CI 0.51–0.83; p<0.001).
Safety and dosing (from FDA summary)
Most common adverse reactions (≥20%) included hypertension, palmar-plantar erythrodysesthesia, proteinuria, dysphonia, abdominal pain, diarrhea, and asthenia. Recommended dose: 5 mg orally once daily, with or without food, days 1–21 of a 28-day cycle.
The review was conducted under Project Orbis; reviews at other agencies were ongoing at the time of the FDA announcement.