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# FDA Accelerated Approval for BMS’ Augtyro Cancer Drug
- URL: https://www.fdaweb.com/fda-accelerated-approval-for-bms-augtyro-cancer-drug/
- Published: 2024-06-13T12:00:00.000Z
- Updated: 2026-09-14T14:33:11.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157178

FDA has granted accelerated approval for Bristol Myers Squibb’s Augtyro (repotrectinib) for adult and pediatric patients aged 12 and older with NTRK (neurotrophic tyrosine receptor kinase) gene fusion-positive solid tumors that are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and that have progressed following treatment or have no satisfactory alternative therapy. An agency [notice](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-repotrectinib-adult-and-pediatric-patients-ntrk-gene-fusion-positive?utm%5Fmedium=email&utm%5Fsource=govdelivery) says Augtyro’s efficacy was evaluated in the TRIDENT-1 trial in 88 adult patients.

The most common adverse reactions in the clinical trial were dizziness, dysgeusia, peripheral neuropathy, constipation, dyspnea, fatigue, ataxia, cognitive impairment, muscular weakness, and nausea.

FDA says its review used the Assessment Aid that BMS voluntarily submitted to facilitate the agency’s assessment. The application was granted priority review and fast-track, breakthrough therapy, and orphan drug designations.