ROZLYTREK (Roche Products Pty Ltd)

Non-small cell lung cancer (NSCLC)

ROZLYTREK (hard capsule) is indicated for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) whose tumours are ROS1-positive.

Solid tumours

ROZLYTREK is indicated for the treatment of adult and paediatric patients 12 years of age and older with solid tumours that:

• have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation,
• are metastatic or where surgical resection is likely to result in severe morbidity, and
• have either progressed following treatment or have no satisfactory alternative therapy.

This indication was approved via the provisional approval pathway, based on objective response rate and duration of response in single-arm trials. Full registration for this indication depends on verification and description of clinical benefit in confirmatory trials.