Augtyro FDA Approval History
Last updated by Judith Stewart, BPharm on Nov 16, 2023.
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
Augtyro (repotrectinib) is a tyrosine kinase inhibitor (TKI) for the treatment of patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC).
- Patients are selected for treatment with Augtyro for locally advanced or metastatic NSCLC based on the presence of ROS1 rearrangement(s) in tumor specimens. An FDA-approved test to detect ROS1 rearrangements is not currently available.
- ROS1-positive non-small cell lung cancer occurs when the ROS1 gene fuses with part of another gene. The fusion causes the ROS1 gene to remain activated causing uncontrolled cell growth and cancer. ROS1-positive lung cancer tends to be aggressive and can spread to the brain and the bones.
- Augtyro contains repotrectinib which is an inhibitor of proto-oncogene tyrosine-protein kinase ROS1 (ROS1) and of the tropomyosin receptor tyrosine kinases (TRKs) TRKA, TRKB, and TRKC. Repotrectinib works in the treatment of ROS1-positive NSCLC by targeting the ROS1 oncogenic fusions.
- FDA approval of Augtyro was based on the pivotal TRIDENT-1 trial, a Phase 1/2 trial that evaluated the safety, tolerability, pharmacokinetics and anti-tumor activity of Augtyro in TKI-naïve and TKI-pretreated patients with advanced solid tumors (including NSCLC) harboring ROS1 fusions.
- Of the 79% of TKI-naïve patients who responded to treatment, 6% experienced complete responses and 73% experienced partial responses. The median duration of response was 34.1 months.
- Of the 38% of TKI-pretreated patients who responded to treatment, 5% experienced complete responses and 32% experienced partial responses. The median duration of response was 14.8 months. - 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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