KISQALI

批准信原文要点

This Prior Approval supplemental new drug application provides for the labeling updates to the Pediatric Use Section of the ribociclib label based on the results of Study CLEE011Q12101, as outlined in the pediatric written request Amendment 2, dated September 26, 2025.

批准信原文要点

These Prior Approval supplemental new drug applications provide for the following: • Changes in the drug product manufacturing process • Addition of an in-process control • Addition of suppliers of primary packaging materials with reference to the Drug Master Files (type III) • Change to the approved stability protocol • Change in the drug product storage condition and an extension of the expiration dating period • Labeling updates

批准信原文要点

This Prior Approval sNDA provides for the removal of the the text phrase, “excluding microscopic nodal involvement”, because it was erroneously included in the Study CLEE011O12301C (NATALEE) description of the patient population.

批准信原文要点

This “Changes Being Effected” sNDAs provides for the revised carton labeling for the 400 mg and 600 mg professional samples. As requested by the FDA, "PHARMACIST" was removed from the flag label so it states “ATTENTION: Store refrigerated until dispensed to patient".

批准信原文要点

These Prior Approval supplemental new drug applications provide for a new indication for: Kisqali is indicated in combination with an aromatase inhibitor for the adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III early breast cancer at high risk of recurrence.

批准信原文要点

These “Changes Being Effected in 30 days” supplemental new drug applications provide for the following:

批准信原文要点

This Prior Approval supplemental new drug application provides for an expanded indication for the use of: KISQALI is indicated for the treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with fulvestrant as initial endocrine-based therapy or with disease progression following endocrine therapy.

批准信原文要点

These Prior Approval sNDA’s provides for the initial labeling submission to include bioavailability data in the USPI from BA Study CLEE011A2117. Additionally, the label also corrects a typo within the Hazard Ratio Confidence Interval for MONALEESA-2.

批准信原文要点

These Prior Approval supplemental new drug applications provides for a labeling revision to the U.S. Prescribing Information (USPI) which adds the final overall survival analysis from the clinical trial entitled “MONALEESA-2” CLEE011A2301.

批准信原文要点

These Prior Approval supplemental new drug applications provides for the addition of male patients to the indications for Kisqali and Kisqali Femara Co-Pack

批准信原文要点

This sNDA provides for revisions to the US Prescribing Information (USPI) Section 5 Warnings and Precautions Subsection 5.3 QT Interval Prolongation, Section 6 Adverse Reactions Subsection 6.1 Clinical Trials Experience, and Section 13 Nonclinical Toxicology Subsection 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility with minor editorial revisions made throughout the USPI.

批准信原文要点

Prior Approval supplement new drug application NDA 209092/S-005 provides for updates to Section 14 of the Full Prescribing Information (Clinical Studies) to add efficacy data from CLEE011F2301 (MONALEESA-3) to fulfill PMC 3453-2 from the July 18, 2018, approval letter for S-001.In addition, the Full Prescribing Information was updated to add a new Severe Cutaneous Adverse Reactions subsection to Section 5 (Warnings and Precautions) with information regarding toxic epidermal necrolysis (TEN), Stevens-Johnson Syndrome (SJS), and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). Related updates were also made to Highlights, Section 2 (Dosage and Administration), Section 6 (Adverse Reactions), and Section 17 (Patient Counseling Information).

批准信原文要点

Prior Approval supplement new drug application NDA 209092/S-003 provides for updates to Section 14 of the Prescribing Information to add efficacy data from study CLEE011E2301 (MONALEESA-7) to fulfill PMC 3453-1 from the July 18, 2018 approval letter for S-001. In addition, this supplement proposes updates to Sections 8.7 (Renal Impairment) and 12.3 (Pharmacokinetics – Patients with Renal Impairment) of the Prescribing Information to reflect the results of the dedicated renal impairment study A2116 Part 2 in mild and moderate renal impairment. The proposed Prescribing Information maintains the current dosing recommendations for mild and moderate renal impairment.

批准信原文要点

This supplemental new drug application provides for revisions to the labeling for Kisqali (ribociclib) consistent with our July 15, 2019, Safety Labeling Change Notification letter.

批准信原文要点

This Prior Approval supplemental new drug application expands the approved indication of KISQALI for the treatment of women with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative advanced or metastatic breast cancer.