Ntrk Gene Fusion Solid Tumors

• CLINICAL_TRIALS research · 2025-06-22
  Clinical Trial Update: A Study to Test the Safety and Efficacy of the Drug Larotrectinib for the Treatment of Tumors With NTRK-fusion in Children [Phase 1, Phase 2]

  Clinical trial update for a Phase 1/2 study of larotrectinib in pediatric tumors with NTRK gene fusions; the study is active but not current…

• FDA approval · 2025-04-09
  FDA Approved: VITRAKVI — Supplemental Application (Loxo Oncology, Inc.)

  FDA approved a supplemental application for VITRAKVI (larotrectinib) to expand its labeling for patients with solid tumors that harbor NTRK …

• FDA approval · 2023-11-15
  FDA Approved: AUGTYRO — Original Application (E.R. Squibb & Sons, L.L.C.)

  FDA approves AUGTYRO (repotrectinib) from E.R. Squibb & Sons as the original approval. The indication covers NTRK gene fusion solid tumors, …

• FDA approval · 2023-06-16
  FDA Approved: ROZLYTREK — Supplemental Application (Genentech, Inc.)

  The FDA approved a supplemental application for Rozlytrek (entrectinib) submitted by Genentech, Inc.

• FDA approval · 2022-11-23
  FDA Approved: VITRAKVI — Supplemental Application (Loxo Oncology, Inc.)

  The FDA approved a supplemental application for VITRAKVI (larotrectinib) by Loxo Oncology, Inc., resulting in an updated label and/or expand…

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• FDA approval · 2019-08-15
  FDA Approved: ROZLYTREK — Original Application (Genentech, Inc.)

  The FDA granted approval of Rozlytrek (entrectinib) in an original NDA for adult and pediatric patients with solid tumors that harbor NTRK g…

• FDA approval · 2018-11-26
  FDA Approved: VITRAKVI — Original Application (Loxo Oncology, Inc.)

  FDA approved VITRAKVI (larotrectinib) for solid tumors that harbor NTRK gene fusions, regardless of tumor site. This tissue-agnostic indicat…