AUGTYRO

What it is

AUGTYRO is repotrectinib, supplied as hard capsules containing 40 mg or 160 mg of repotrectinib. Repotrectinib is a tyrosine kinase inhibitor that inhibits the proto-oncogene tyrosine-protein kinase ROS1. This medicinal product is subject to additional monitoring in Australia.

Approved indications —

AUGTYRO, as monotherapy, is indicated for the treatment of adult patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC).

Dosing overview

The recommended dose is 160 mg orally once daily for 14 days, followed by 160 mg orally twice daily until disease progression or unacceptable toxicity. AUGTYRO may be taken with or without food. Swallow capsules whole at the same time each day. Do not open, crush, chew, or dissolve the contents of the capsule.

Key safety warnings

AUGTYRO can cause a broad spectrum of central nervous system adverse reactions including dizziness, ataxia, and cognitive disorders. Advise patients and caregivers of these risks as they may influence the ability to drive and use machines. Advise patients not to drive or use machines if they are experiencing central nervous system adverse reactions. AUGTYRO can cause interstitial lung disease or pneumonitis. Advise patients to report its symptoms, which may include shortness of breath, cough, wheezing, chest pain or tightness, and haemoptysis. Immediately withhold AUGTYRO in patients with suspected interstitial lung disease or pneumonitis and permanently discontinue AUGTYRO if interstitial lung disease or pneumonitis is confirmed. AUGTYRO can cause hepatotoxicity. Monitor liver function tests, including ALT, AST and bilirubin, every 2 weeks during the first month of treatment, then monthly thereafter and as clinically indicated. AUGTYRO can cause myalgia with or without creatine phosphokinase elevation. Advise patients to report any unexplained muscle pain, tenderness, or weakness. AUGTYRO can cause hyperuricaemia. Monitor serum uric acid levels prior to initiating AUGTYRO and periodically during treatment. Initiate treatment with urate-lowering medications as clinically indicated. AUGTYRO increases the risk of skeletal fractures. Promptly evaluate patients with signs or symptoms of fractures.

Contraindications

Hypersensitivity to the active substance or to any of the excipients.

PBS listing

AUGTYRO 160 mg capsules are listed on the PBS with authority required restriction and an ex-manufacturer price of A$9500.00. AUGTYRO 40 mg capsules are also listed with authority required restriction and an ex-manufacturer price of A$7528.28.

Regulatory history

AUGTYRO received its first ARTG approval on 25 July 2025. An AusPAR (Australian Public Assessment Report) was issued on 2025-07-23. The PBAC recommended AUGTYRO in May 2025 for the treatment of locally advanced or metastatic ROS1-positive non-small cell lung cancer.