NERLYNX

批准信原文要点

This Prior Approval supplemental new drug application provides for updates to the Dosage and Administration, Warnings and Precautions, and Patient Counseling Information sections of the Full Prescribing Information based on data from the CONTROL trial (PUMA-NER-6201) regarding prevention and management of neratinib-associated diarrhea.

批准信原文要点

This Prior Approval supplemental new drug application provides for updates to section 14 of the U.S. prescribing information to include the final overall survival analysis based on results from ExteNET clinical trial. In addition, AST was added to the dose modifications for hepatotoxicity in Table 7.

批准信原文要点

Supplement 006: Revisions to the Drug Interactions and Clinical Pharmacology sections of the Prescribing Information based on the final study reports for PMR 3223-1 and PMC 3223-4.

批准信原文要点

Supplement 005: A new indication for neratinib, for use in combination with capecitabine, for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting.

批准信原文要点

This Prior Approval supplemental new drug application provides for updates to the Dosage and Administration, Warning and Precautions, Adverse Reactions and Clinical Trials Experience sections of the Full Prescribing Information regarding the management of diarrhea when on Nerlynx® based on the PUMA-NER-6201 interim clinical study report.

批准信原文要点

This “Changes Being Effected” supplemental new drug application provides for the addition of a tamper-resistant, adhesive “SAMPLE – NOT FOR SALE” sticker to the carton label of the 126 count bottle professional sample.

批准信原文要点

This Prior Approval supplemental new drug application provides for updates to the Nerlynx® USPI based on the final reports submitted for the postmarketing requirement and commitment on the 2-year rat carcinogenicity study and H2-receptor antagonist drug-drug interaction study.