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 not distributed through mainland China's retail pharmacy network. Uwell Cloud can help arrange a purchase channel for this medicine, sourced and dispatched from Hong Kong; clinical administration support in China can be coordinated on request. Availability and eligibility for any specific patient are determined by clinical review.

Regulatory Approvals

• FDA — Approved (2023) — Sources

Pivotal Clinical Evidence

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

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