ROZLYTREK

批准信原文要点

notifying you, under Section 505(o)(4)… risk of Brugada syndrome. This supplemental new drug application provides for revisions to the labeling for entrectinib… Ventricular Arrhythmias which was reordered to Section 5.2…

批准信原文要点

This Prior Approval sNDA provides for revisions to Section 2 Dosing and Administration: Subsection 2.2 Recommended Evaluation and Testing Before Initiating Rozlytrek and Section 5 Warnings and Precautions: Subsection 5.1 Congestive Heart Failure, of the Full Prescribing Information (FPI) to include left ventricular ejection fraction monitoring of all patients prior to administration of entrectinib.

批准信原文要点

This Prior Approval sNDA provides for treatment of adult and pediatric patients older than 1 month of age with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation as detected by an FDA-approved test, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy, and for a new route and method of administration for capsules prepared as an oral suspension.

批准信原文要点

This Prior Approval sNDA provides updates to the Rozlytrek (entrectinib) Prescribing Information (PI), Dosage and Administration, Patient Selection subsection.

批准信原文要点

This Prior Approval sNDA provides for updates to the Use in Specific Population, Hepatic Impairment subsection and the Clinical Pharmacology, Pharmacokinetics subsection of the Prescribing Information (PI) to include data intended to evaluate the effect of moderate and severe hepatic impairment on the pharmacokinetics and safety of Rozlytrek (entrectinib) compared to subjects with normal hepatic function.

批准信原文要点

This Prior Approval sNDA provides for updates to Section 1 INDICATIONS AND USAGE and Section 2 DOSAGE AND ADMINISTRATION of the Rozlytrek (entrectinib) US Prescribing Information (PI) making reference to an FDA-approved companion diagnostic...