Novartis receives SMC approval for early breast cancer treatment
Charlie Blackie-Kelly | November 11, 2025 | News story | Research and Development | Novartis, Scottish Medicines Consortium, breast cancer, nhs scotland
Novartis has announced that its treatment for early breast cancer, Kisqali (ribociclib), has received approval for use within NHS Scotland from the Scottish Medicines Consortium (SMC).
The recommendation allows Kisqali to be prescribed as an adjuvant therapy in combination with an aromatase inhibitor (AI) for eligible patients with hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) early breast cancer (eBC) at high risk of recurrence.
For pre- or perimenopausal women, as well as men, the AI should be administered alongside a luteinising hormone-releasing hormone (LHRH) agonist.
Kisqali is a CDK4/6 inhibitor that slows cancer growth by blocking the activity of the CDK4 and CDK6 proteins, which, when overactive, can cause cancer cells to grow and multiply too quickly.
The SMC decision follows data from the phase 3 NATALEE trial, which showed statistically significant and clinically meaningful improvements in invasive disease-free survival.
“The SMC’s decision to accept ribociclib as a treatment option for eligible patients is an important step forward for those in Scotland and means that the treatment is now available for all eligible patients in the UK,” said Johan Kahlström, President & Managing Director of Novartis UK & Ireland.
Breast cancer remains one of the most common cancers in the UK, with the number of women living with the disease in Scotland expected to increase by 30% to 71,000 by 2044. HR+/HER2- is the most prevalent subtype, accounting for approximately 70% of cases.
This article featured in: December 2025 – The Pharmafile Brief
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