Ntrk Gene Fusion-positive Solid Tumors

• CLINICAL_TRIALS trial_result · 2024-08-29
  Clinical Trial Update: Food Effect and Relative Bioavailability Study of VC004 Capsules in Healthy Adult Subjects [Phase 1]

  Phase 1 study assessing the food effect and relative bioavailability of VC004 capsules in healthy adult subjects. The disease context refere…

• FDA label_change · 2023-11-03
  FDA Approved: VITRAKVI — Supplemental Application (Loxo Oncology, Inc.)

  FDA supplemental approval expands VITRAKVI's label to include treatment of NTRK gene fusion-positive solid tumors.

• FDA approval · 2023-10-20
  FDA Approved: ROZLYTREK — Original Application (Genentech, Inc.)

  Rozlytrek (entrectinib) received FDA approval in an original application for the treatment of NTRK gene fusion-positive solid tumors and ROS…

• FDA approval · 2023-08-31
  FDA Approved: ROZLYTREK — Supplemental Application (Genentech, Inc.)

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