VITRAKVI larotrectinib

Drug Class

Tropomyosin receptor kinase (TRK) inhibitor

Mechanism

Selectively inhibits TRKA, TRKB, and TRKC phosphorylation, blocking downstream tumor survival pathways in cancers harboring NTRK gene fusions.

Approved Indication

FDA-approved for adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, and are metastatic or where surgical resection is likely to result in severe morbidity.

What This Means For Patients

VITRAKVI is a highly selective tumor-agnostic TRK inhibitor. Approved by the FDA and EMA for tumors with NTRK fusions, it is clinically accessible under Hainan pilot-zone regulations.

Regulatory Approvals

• FDA — approved (2018) — label
• EMA — approved (2019) — source

Pivotal Clinical Evidence

• NAVIGATE — Drilon et al., N Engl J Med 2018 (NCT02576431) — DOI

Sources

• https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210861s000,211710s000lbl.pdf
• https://www.ema.europa.eu/en/medicines/human/EPAR/vitrakvi