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 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 (2018) — Sources
• EMA — Approved (2019) — Sources

Pivotal Clinical Evidence

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

Sources

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