Repotrectinib

What it is used for

AUGTYRO is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic ROS1- positive non-small cell lung cancer (NSCLC). adult and pediatric patients 12 years of age and older with solid tumors that: have a neurotrophic tyrosine receptor kinase ( NTRK ) gene fusion and are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity.

have progressed following treatment or have no satisfactory alternative therapy. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

1.1 ROS1 -Positive Non-Small Cell Lung Cancer AUGTYRO is indicated for the treatment of adult patients with locally advanced or metastatic ROS1 -positive non-small cell lung cancer (NSCLC). 1.2 NTRK Gene Fusion-Positive Solid Tumors AUGTYRO is indicated for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that: have a neurotrophic tyrosine receptor kinase ( NTRK ) gene fusion, are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy.

This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Side effects, and when to stop

The following clinically significant adverse reactions are described elsewhere in the labeling:

• Central Nervous System Adverse Reactions
• Interstitial Lung Disease (ILD)/Pneumonitis
• Hepatotoxicity
• Myalgia with Creatine Phosphokinase Elevation
• Hyperuricemia
• Skeletal Fractures
• Embryo-Fetal Toxicity

Who should not take it

None.