FDA Approves Vitrakvi® (larotrectinib), the First Ever TRK Inhibitor, for Patients with Advanced Solid Tumors Harboring an NTRK Gene Fusion(1,2)

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Nov 27, 2018
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  • First treatment with a tumor-agnostic indication at the time of initial FDA approval
  • 75% overall response rate (ORR) (95% CI, 61%, 85%) [22% complete response (CR) and 53% partial response (PR)] across various solid tumors in adults and children (N=55)2
  • Adverse events (AE) of any grade observed in 20% or more of patients, regardless of attribution, included increased ALT (45%), increased AST (45%), anemia (42%), fatigue (37%), nausea (29%), dizziness (28%), cough (26%), vomiting (26%), constipation (23%), and diarrhea (22%)2