Augtyro repotrectinib

Drug Class

Kinase inhibitor

Mechanism

Inhibits ROS1 and NTRK kinases, thereby blocking downstream signaling pathways that drive tumor cell survival and proliferation.

Approved Indication

ROS1-positive locally advanced or metastatic non-small cell lung cancer, and NTRK gene fusion-positive advanced solid tumors, per its FDA approval.

What This Means For Patients

Augtyro is a targeted kinase inhibitor used to treat advanced non-small cell lung cancer with ROS1 fusions and NTRK-positive solid tumors. It is designed to target specific genetic alterations driving tumor growth and is available under special import policies at Hainan Boao Lecheng.

Regulatory Approvals

• FDA — approved (2023) — label

Pivotal Clinical Evidence

• TRIDENT-1 — Drilon et al., N Engl J Med 2024 (NCT03093116) — DOI

Sources

• https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-repotrectinib-ros1-positive-non-small-cell-lung-cancer
• https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/218486s000lbl.pdf