ALUNBRIG

批准信原文要点

This Prior Approval sNDA provides for revisions to the CLINICAL STUDIES (14) section of the US Prescribing Information (USPI) for Alunbrig, incorporating additional long-term efficacy data supported by findings from Study 301 (ALTA 1L). This sNDA also provides for revisions to the DOSAGE AND ADMINISTRATION (2.3, Dosage Modifications for Adverse Reactions), WARNINGS AND PRECAUTIONS (5.7, Hepatotoxicity), and PATIENT COUNSELING INFORMATION (17) sections of the USPI. Additionally, the ADVERSE REACTIONS (6) section of the USPI and the Patient Package Insert were revised for brevity and consistency.

批准信原文要点

This sNDA provides for revisions to Section 5 Warnings and Precautions subsection 5.8 Photosensitivity, Section 6 Adverse Reactions subsection 6.1 Clinical Trials Experience, Section 17 Patient Counseling Information of the U.S .Prescribing Information to add the adverse react…

批准信原文要点

This Prior Approval supplemental new drug application provides for modifications of the approved indication for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib on April 28, 2017, under the provisions of 21 CFR 314.510, to remove the following language (italicized) limiting the indication to patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib and removing the statements that This indication is approved under accelerated approval

批准信原文要点

This Prior Approval supplemental new drug application provides for the following changes to the U.S. prescribing information: To revise the Dosage and Administration, Dosage Modification for Strong or Moderate CYP3A Inhibitors (2.3) subsection, the Drug Interactions, Effect of Other Drugs on ALUNBRIG (7.1) subsection and the Clinical Pharmacology, Pharmacokinetics (12.3) subsection to recommend that patients avoid co-administration with a moderate CYP3A inhibitor during treatment with ALUNBRIG;

批准信原文要点

This new drug application provides for the use of Alunbrig (brigatinib) tablets, 30 and 90 mg for treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib.