FDA D.I.S.C.O. Burst Edition: FDA approval of Fruzaqla (fruquintinib) for adult patients with metastatic colorectal cancer

Regulatory approval: On Nov 8, 2023, the FDA approved fruquintinib (Fruzaqla) 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 FRESCO-2 and FRESCO, where overall survival favored fruquintinib vs placebo. Reviews at other agencies are ongoing under Project Orbis.

FDA approval (Nov 8, 2023): Fruzaqla (fruquintinib) in metastatic colorectal cancer

The FDA granted regulatory approval on November 8, 2023 for fruquintinib (Fruzaqla) for adult patients with metastatic colorectal cancer (mCRC) who have received prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and—if RAS wild-type and medically appropriate—an anti-EGFR therapy.

Efficacy evidence was evaluated in FRESCO-2 and FRESCO.

  • FRESCO-2: International, multicenter, randomized, double-blind, placebo-controlled trial (n=691) in patients with mCRC progressing during/after standard therapies, including an anti-VEGF biologic, an anti-EGFR biologic if RAS wild-type, and at least one of trifluridine/tipiracil or regorafenib.
  • FRESCO: Multicenter, placebo-controlled trial in China (n=416) in patients progressing during/after fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.

In both studies, patients were randomized 2:1 to fruquintinib 5 mg orally once daily vs placebo on days 1–21 of each 28-day cycle plus best supportive care, until progression or unacceptable toxicity.

Major endpoint: overall survival (OS).

  • FRESCO-2 median OS: 7.4 vs 4.8 months (fruquintinib vs placebo)
  • FRESCO median OS: 9.3 vs 6.6 months

Common adverse reactions (>20%): hypertension, palmar-plantar erythrodysesthesia, proteinuria, dysphonia, abdominal pain, diarrhea, asthenia.

The review was conducted under Project Orbis; reviews at other agencies are ongoing.

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