Prescribing information (external link)

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Five-year outcomes from the NATALEE trial

Indications:1

 

  • KISQALI® (ribociclib) in combination with an aromatase inhibitor (AI), is indicated for the adjuvant treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer (eBC) at high risk of recurrence (see section 5.1 of the SmPC for eligibility criteria)

  • In pre/perimenopausal women, or in men, the AI should be combined with a luteinising hormone-releasing hormone (LHRH) agonist

KISQALI is not recommended to be used in combination with tamoxifen.

For information on the safety profile of KISQALI in eBC, click here.

Please refer to the Summary of Product Characteristics (SmPC) for the full safety profile and guidance regarding managing adverse events (AEs).

Click the play button below to watch the video from Dr John Crown

Join Dr John Crown as he discusses the 5-year data from NATALEE in patients with HR+/HER2– eBC.

AE, adverse event; AI, aromatase inhibitor; eBC, early breast cancer; ESMO, European Society for Medical Oncology; HCP, healthcare professional; HER2–, human epidermal growth factor receptor 2-negative; HR+, hormone receptor-positive; LHRH, luteinising hormone-releasing hormone; SmPC, summary of product characteristics.

Reference

  1. KISQALI® (ribociclib) Summary of Product Characteristics.

UK | April 2026 | FA-11543305-1

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Novartis online through the pharmacovigilance intake (PVI) tool at www.novartis.com/report, or alternatively email [email protected] or call 01276 698370.