ERLEADA

批准信原文要点

This Prior Approval sNDA provides for the addition of a new Drug Interactions subsection 7.3 (Laboratory Test Interference) and corresponding new Warnings and Precautions subsection 5.8 (Interference with Immunoassay Measurement of Digoxin).

批准信原文要点

This Prior Approval sNDA provides for the addition of hepatic impairment data to Section 2.3… Section 8.6… and Section 12.3 Pharmacokinetics, as well as the addition of lichenoid eruption to Section 6 Adverse Reactions and Section 6.2 Post-Marketing Experience. In addition, this sNDA provides for corresponding changes to the Patient Information.

批准信原文要点

This Prior Approval sNDA provides for updates to the U.S. Prescribing Information to add Interstitial Lung Disease/Pneumonitis to Section 2.2, Dosage Modification, Section 5, Warnings and Precautions, Subsection 5.6; Section 6, Adverse Reactions; and corresponding updates to Subsection 6.1, Clinical Trial Experience and Subsection 6.2, Post-Marketing Experience. In addition, this Prior Approval sNDA provides for corresponding changes to the Patient Package Insert.

批准信原文要点

This Prior Approval sNDA provides for alternate administration methods for the apalutamide 60 mg FC tablets, in order to align with administration instructions for apalutamide 240 mg FC tablets.

批准信原文要点

This Prior Approval supplemental new drug application provides for revision to Section 12.2 Pharmacodynamics in the U.S. Prescribing Information.

批准信原文要点

This Prior Approval sNDA provides for the addition of Erleada 240 mg tablet formulation to Section 2- Dosage and Administration, Section 3- Dosage Forms and Strengths, Section 11- Description, Section 16- How Supplied/Storage and Handling and corresponding revisions to Section 17- Patient Counseling Information, Patient Package Insert (PPI), carton and container labeling and the creation of an Instructions for Use (IFU).

批准信原文要点

These Prior Approval sNDAs provide for the addition of Severe Cutaneous Adverse Reactions (SCARs), including Stevens Johnson syndrome/toxic epidermal necrolysis (SJS/TEN) and Drug reaction with eosinophilia and systemic symptoms (DRESS) to Section 5, Warnings and Precautions, Subsection 5.5 of the United States Prescribing information (USPI) for Erleada (apalutamide) with corresponding revisions to Section 6 Adverse Reactions: Subsection 6.2 Post Marketing Experience, and Section 17 Patient Counseling Information of the Full Prescribing Information (FPI) with corresponding changes to the Patient Package Insert (PPI).

批准信原文要点

These Prior Approval sNDAs provide for the addition of Severe Cutaneous Adverse Reactions (SCARs), including Stevens Johnson syndrome/toxic epidermal necrolysis (SJS/TEN) and Drug reaction with eosinophilia and systemic symptoms (DRESS) to Section 5, Warnings and Precautions, Subsection 5.5 of the United States Prescribing information (USPI) for Erleada (apalutamide) with corresponding revisions to Section 6 Adverse Reactions: Subsection 6.2 Post Marketing Experience, and Section 17 Patient Counseling Information of the Full Prescribing Information (FPI) with corresponding changes to the Patient Package Insert (PPI).

批准信原文要点

This Prior Approval sNDA provides for revisions to Section 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility of the Erleada (apalutamide) USPI based on the results of the nonclinical Study TOX11338: A 2-year Carcinogenicity Study of JNJ-56021927-AAA by Oral Gavage in Rats.

批准信原文要点

This Prior Approval supplemental new drug application provides for updates in the U.S. prescribing information for Erleada (apalutamide) to reflect the analysis from the final report for Overall Survival (OS) of the TITAN trial.

批准信原文要点

This Prior Approval supplement provides for nonclinical updates to the following subsections of the prescribing information (PI): Subsection 5.5 (Embryo-Fetal Toxicity), subsection 8.1 (Pregnancy), and subsection 13.1 (Carcinogenesis, Mutagenesis, Impairment of Fertility).

批准信原文要点

This Prior Approval supplemental new drug application provides for labeling revisions to the U.S. prescribing information based on results from the final analysis of overall survival, efficacy and safety from the SPARTAN study ARN-509-003.

批准信原文要点

This Prior Approval supplemental new drug application provides for the addition of toxic epidermal necrolysis and Stevens-Johnson syndrome as adverse drug reactions in Section 6.2 Post-Marketing Experience of the U.S. prescribing information for Erleada (apalutamide).

批准信原文要点

This Prior Approval Supplemental new drug application provides for modifications to Sections 2.3 (Dosage and Administration - Alternate Method of Administration),12.3 (Pharmacokinetics – Absorption), and 17 (Patient Counseling Information) of the U.S. Prescribing Information, along with the Patient Package Insert to allow for patients to mix their daily dosage of apalutamide with applesauce for those who have difficulty swallowing tablets whole.

批准信原文要点

This Prior Approval supplemental new drug application provides for expanding the indication to include the use of Erleada® for treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC).