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These highlights do not include all the information needed to use AUGTYRO safely and effectively. See full prescribing information for AUGTYRO.AUGTYROTM (repotrectinib) capsules, for oral useInitial U.S. Approval: 2023
Medication labelWhy this: Advisory · dailymed-prescription
AUGTYRO is indicated for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) [see Dosage and Administration (2.1)]. 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 [see Dosage and Administration (2.1)], •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 [see Clinical Studies (14.2)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
- generic_name
- repotrectinib
- product_names
- repotrectinib
- ndc
- 0003-4040, 0003-4040-60, 0003-4040-12, 0003-4160, 0003-4160-14, 0003-4160-60
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en