The US FDA has approved repotrectinib for solid tumors with NTRK gene fusion that have progressed after initial treatment. The drug is a tyrosine kinase inhibitor initially approved for ROS1-positive lung cancer. NTRK gene fusions are rare but found in many cancer types. Approval is for patients aged 12 and older based on TRIDENT-1 trial showing response rates of 58% for TKI-naive patients and 50% for those who had prior TKI. Common side effects include dizziness, neuropathy, and fatigue. The drug costs approximately $7644 for a 60-capsule supply. Warning labels include CNS reactions and embryo-fetal toxicity. The recommended dose is 160 mg orally once daily.
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FDA Expands Repotrectinib Label
