Augtyro FDA Approval History
Last updated by Judith Stewart, BPharm on June 18, 2024.
FDA Approved: Yes (First approved November 15, 2023)
Brand name: Augtyro
Generic name: repotrectinib
Dosage form: Capsules
Company: Bristol-Myers Squibb Company
Treatment for: Non Small Cell Lung Cancer, Solid Tumors
Augtyro (repotrectinib) is a tyrosine kinase inhibitor (TKI) for the treatment of patients with ROS1-positive non-small cell lung cancer (NSCLC) and NTRK-positive metastatic solid tumors.
- Augtyro is 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. - Augtyro capsules are administered orally once daily for 14 days, then twice daily, with or without food.
- Warnings and precautions associated with Augtyro include central nervous system (CNS) effects, interstitial lung disease (ILD)/pneumonitis, hepatotoxicity, myalgia with creatine phosphokinase elevation, hyperuricemia, skeletal fractures, and embryo-fetal toxicity.
- Common adverse reactions include dizziness, dysgeusia, peripheral neuropathy, constipation, dyspnea, ataxia, fatigue, cognitive disorders, and muscular weakness.
Development timeline for Augtyro
Further information
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