VITRAKVI

批准信原文要点

This Prior Approval sNDA provides an update to the Vitrakvi (larotrectinib) Prescribing Information (PI) and Patient Information with efficacy and safety results from three clinical studies... supporting the conversion from accelerated approval to regular approval

批准信原文要点

This Prior Approval Supplemental new drug application provides revisions to the Vitrakvi (larotrectinib) United States Prescribing Information (USPI) to include safety updates to Section 5.3 (Hepatotoxicity) and related sections, the addition of Section 2.4 (dose modifications for hepatoxicity), and the addition of Section 6.2 Post Marketing Experience to include liver injury.

批准信原文要点

This Prior Approval labeling supplement provides for revisions to Section 2.5 Dosage Modifications for Coadministration with Strong or Moderate CYP3A4 Inducers, Section 7.1 Effects of Other Drugs on Vitrakvi, and Section 12.3 Pharmacokinetics of the Vitrakvi (larotrectinib) Prescribing Information (PI).

批准信原文要点

This Prior Approval supplemental new drug application provides for updates to the labeling and specifically the Prescribing Information (PI) consistent with our October 19, 2020, request to incorporate language in sections 1 (Indications and Usage) and 2.1 (Patient Selection) regarding an approved companion diagnostic (CDx).

批准信原文要点

This Prior Approval sNDA provides for revisions to the prescribing information (PI) updating the response data from patients with NTRK fusion solid tumors. Additionally, labeling changes were made to Adverse Reactions (Section 6.1) and Pediatric Use (Section 8.4) based on updated safety data expanding the safety population. Warnings and Precautions Section 5.1 was updated to “Central Nervous System Effects” with language to clarify cognitive impairment and other disorders and to Section 5.2 to update “Skeletal Fractures” language. Finally, edits … were made to the Patient Information and Instructions for Use.