Augtyro

Treats locally advanced or metastatic ROS1- positive non-small cell lung cancer (NSCLC). NDA 218213, held by Bristol. Repotrectinib.

As of Nov 13, 2026, NDA 218213 (Augtyro), held by Bristol, was first approved by FDA on Nov 15, 2023, with 1 approved supplement and 0 published complete response letters.

First approved: Nov 15, 2023
Review: Priority
Supplements approved: 1
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

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
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.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first

Date	Submission	Status	Documents
Jun 13, 2024	Supplement 1Efficacy (new indication or use) · Priority review	Approved	Review Letter Label
Nov 15, 2023	Original applicationNew molecular entity · Priority review	Approved	Review Label Letter

Products

2 strengths and forms

Product	Active ingredient	Marketing
Augtyro40MG · capsule;oral	Repotrectinib	RxReference drug
Augtyro160MG · capsule;oral	Repotrectinib	RxReference drug

Identifiers

Application: NDA 218213
Drugs@FDA: Overview at FDA
Company: Bristol Laboratories

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters