FRUZAQLA

What it is

FRUZAQLA is a medicine containing fruquintinib. Fruquintinib is a small molecule tyrosine kinase inhibitor of vascular endothelial growth factor receptors (VEGFR)-1, -2, and -3, with antitumor effects resulting from suppression of tumour angiogenesis. This medicinal product is subject to additional monitoring in Australia.

Approved indications

— Treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF agent, and an anti-EGFR agent if appropriate.

Dosing overview

The recommended dose of FRUZAQLA is 5 mg taken orally once daily (at approximately the same time each day) for the first 21 days of each 28-day cycle. FRUZAQLA capsules should be swallowed whole, and can be taken with or without food. Treatment with FRUZAQLA should be continued until disease progression or unacceptable toxicity occurs.

Key safety warnings

FRUZAQLA can cause hypertension. Amongst 911 patients with mCRC who received FRUZAQLA in clinical trials, hypertension occurred in 49%, including Grade 3–4 events in 19%, and hypertensive crisis in three patients (0.3%). The median time to first onset of hypertension was 14 days from first dose of FRUZAQLA. Do not initiate FRUZAQLA unless blood pressure is adequately controlled. Monitor blood pressure weekly the first month, at least monthly thereafter and as clinically indicated. Initiate or adjust anti-hypertensive therapy as appropriate. FRUZAQLA can cause serious haemorrhagic events, which may be fatal. Amongst 911 patients with mCRC who received FRUZAQLA in clinical trials, 6% experienced a gastrointestinal haemorrhage, including 13 Grade ≥3 events (1% of patients) and 2 fatal events (0.2% of patients). Monitor haematologic and coagulation profiles more frequently in patients at risk for bleeding, including due to concomitant anticoagulants. Withhold, reduce dose, or permanently discontinue FRUZAQLA based on the severity of haemorrhage. FRUZAQLA treatment may cause an increased risk of infections, including fatal infections. Amongst 911 patients with mCRC who received FRUZAQLA across these and other clinical trials, the most common infections were urinary tract infections (6.8%), upper respiratory tract infections (3.2%) and pneumonia (2.5%); fatal infections included pneumonia (0.4%), sepsis (0.2%), bacterial infection (0.1%), lower respiratory tract infection (0.1%), and septic shock (0.1%). Medicines that inhibit the vascular endothelial growth factor (VEGF) signalling pathway can cause gastrointestinal (GI) perforation. Amongst 911 patients with mCRC who received FRUZAQLA in clinical trials, twelve patients (1.3%) experienced a Grade ≥3 gastrointestinal perforation, including one fatal event (0.1%). FRUZAQLA can cause liver injury. Amongst 911 patients with mCRC who received FRUZAQLA in clinical trials, 48% experienced increased ALT or AST, including Grade ≥3 events in 5%, and fatal events in 0.2%. Median time to first onset of elevated liver enzymes was 29 days from first dose of FRUZAQLA. FRUZAQLA can cause proteinuria. Amongst 911 patients with mCRC who received FRUZAQLA in clinical trials, 36% experienced proteinuria and 2.5% of patients experienced Grade ≥3 events. Median time to first onset of proteinuria was 22 days from first dose of FRUZAQLA. FRUZAQLA can cause palmar-plantar erythrodysaesthesia syndrome (PPES). Amongst 911 patients with mCRC who received FRUZAQLA in clinical trials, PPES occurred in 35%, including 8% with Grade 3 events. Median time to first onset of PPES was 19 days from first dose of FRUZAQLA.

Contraindications

Hypersensitivity to the active substance or any of the excipients listed in section 6.1.

PBS listing

FRUZAQLA is listed on the PBS in two strengths: 1 mg capsule at an ex-manufacturer price of A$1319.00 and 5 mg capsule at an ex-manufacturer price of A$6595.00. Both strengths have streamlined restrictions and are listed as of 2026-05-01.

Regulatory history

FRUZAQLA fruquintinib 1 mg and 5 mg hard capsules were first listed on the ARTG on 2 October 2024. The PBAC recommended FRUZAQLA in September 2024 for the treatment of metastatic colorectal cancer. The AusPAR approval date was 1 October 2024. The TGA approved Fruzaqla on 1 October 2024 for the treatment of adult patients with metastatic colorectal cancer who have been previously treated with multiple lines of chemotherapy and targeted agents.