More early breast cancer patients, at high risk of recurrence, gain access to Novartis’ Kisqali® (ribociclib) as the treatment is accepted for use in Scotland

• The Scottish Medicines Consortium (SMC) announced today that they have accepted Kisqali (ribociclib) for use within NHS Scotland as an adjuvant treatment option 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 recurrence¹.
• People treated for HR+/HER2- eBC remain at risk of experiencing a return of their breast cancer, often as incurable advanced disease^2,3. Adjuvant therapies, such as ribociclib, are a type of cancer treatment given after the initial treatments to eliminate remaining cancer cells and reduce the risk of cancer returning.³
• In July 2025, the National Institute for Health and Care Excellence (NICE) recommended ribociclib as a treatment option for patients in England, with the guidance adopted by the NHS in Wales and endorsed for implementation in NI.⁴
• SMC final advice grants access to ribociclib for eligible patients in Scotland, making the treatment option available to more women diagnosed with HR+/HER2- early breast cancer across the UK.

London, 10 November, 2025 – Novartis pharmaceuticals announced today that the Scottish Medicines Consortium (SMC) has published final advice, accepting ribociclib for use in NHS Scotland as an adjuvant treatment option in combination with an aromatase inhibitor (AI) for eligible patients with HR+/HER2- early breast cancer (eBC) at high risk of recurrence (see section 5.1 of the summary of product characteristics for selection criteria). In pre- or perimenopausal women, or in men, the aromatase inhibitor should be combined with a luteinising hormone-releasing hormone (LHRH) agonist^1,5.

Breast cancer is one of the most common cancers in the UK⁶. In Scotland it is estimated that the number of women living with breast cancer will increase by 30% by 2044, rising from 55,000 cases in 2019 to 71,000 by 2044⁷. HR+/HER2- is the most common subtype of breast cancer, making up around 70% of cases⁶. Despite initial treatment, some breast cancer patients remain at risk of breast cancer coming back, often as incurable advanced disease^2,3.

“Cancer remission is often perceived as the final step, but for many patients it’s the beginning of a new chapter, one where the possibility of their disease coming back can be a constant concern. This fear is not only prevalent but also persistent, often affecting mental health, relationships, and daily activities. It is encouraging to see that a broad population of patients with early breast cancer now have access to an additional treatment that will reduce the risk of their cancer recurring” 
– says Kirstin Spencer, Independent Cancer Patients' Voice.

Ribociclib is a CDK 4/6 inhibitor, a class of drugs that slows cancer growth by blocking two proteins, CDK4 and CDK6, which help cancer cells grow and divide. When these proteins are overactive, cancer cells multiply too quickly. Targeting CDK4/6 may help stop cancer cells from replicating uncontrollably⁵.

The SMC final advice is based on results from the Phase III NATALEE trial, which included 5,101 pre-/postmenopausal women and men with HR+/HER2- breast cancer with any lymph node involvement tumour size >5 cm, or tumour size 2-5 cm with either grade 2 (and high genomic risk or Ki67 ≥20%) or grade 3^1,8.

“Ribociclib offers an additional option to reduce the risk of recurrence for patients with high-risk early breast cancer”, said David Cameron, Professor of Oncology and Director of Cancer Services, NHS Lothian at University of Edinburgh. “Until now, we were unable to routinely offer ribociclib to eligible patients through NHS Scotland, despite it recently being made available in England, Northern Ireland and Wales. The SMC decision will provide access to CDK4/6 inhibitors for more early breast cancer patients in Scotland, including those at higher risk whose cancer hasn’t spread to their lymph nodes.”

The primary endpoint of the study was met at the primary analysis (11 January 2023 cut-off). A statistically significant improvement in iDFS (HR: 0.748, 95% CI: 0.618, 0.906; one-sided stratified log-rank test p-value 0.0014) was demonstrated in patients receiving ribociclib plus AI over AI alone. Consistent results were observed across sub-groups of anatomic stage, menopausal status, region, nodal status, age, race, and prior adjuvant/neo-adjuvant chemotherapy or hormonal therapies.⁸ An exploratory 4-year landmark analysis of NATALEE demonstrated a 28.5% reduction in the relative risk of iDFS events compared with AI alone (4.9% absolute risk reduction).⁹

The most common adverse drug reactions (ADRs) (reported at a frequency ≥20%) in the dataset for which the frequency for ribociclib plus aromatase inhibitor (AI) exceeds the frequency for AI alone were neutropenia, infections, nausea, headache, fatigue, leukopenia and abnormal liver function tests. The most common grade 3/4 ADRs (reported at a frequency of ≥2%) in the dataset for which the frequency for ribociclib plus AI exceeds the frequency for AI alone were neutropenia, abnormal liver function tests and leukopenia. The safety profile remained stable with additional follow up.^5,8

“We’re proud to reach yet another milestone in our 30-year commitment to supporting people affected by breast cancer. 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.

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About NATALEE

NATALEE is a global Phase III multi-centre, randomised, open-label trial to evaluate the efficacy and safety profile of ribociclib with AI as an investigational adjuvant treatment versus AI alone, in patients with stage II and III HR+/HER2- eBC, being conducted in collaboration with TRIO. Pre-/perimenopausal women and men in both groups were also treated with an LHRH agonist.

The adjuvant AI in both treatment arms was a non-steroidal aromatase inhibitor (NSAI; anastrozole or letrozole) and goserelin if applicable. The primary endpoint of NATALEE is invasive disease-free survival (iDFS) as defined by the Standardised Definitions for Efficacy End Points (STEEP) criteria. A total of 5,101 adult patients with HR+/HER2- eBC across 20 countries were randomised in the trial^8,10.

About ribociclib

Ribociclib is a selective cyclin-dependent kinase inhibitor, a class of drugs that help slow the progression of cancer by inhibiting two proteins called cyclin-dependent kinase 4 and 6 (CDK4/6). These proteins, when over-activated, can enable cancer cells to grow and divide too fast. Targeting CDK4/6 proteins may play a role in ensuring that cancer cells do not continue to replicate uncontrollably⁵.

In the UK, ribociclib is licensed in combination with an aromatase inhibitor for the adjuvant treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer at high risk of recurrence (see section 5.1 for selection criteria). In pre- or perimenopausal women, or in men, the aromatase inhibitor should be combined with a luteinising hormone-releasing hormone (LHRH) agonist⁵.

It is also licensed for the treatment of women with HR-positive, HER2-negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy. In pre- or perimenopausal women, the endocrine therapy should be combined with a LHRH agonist⁵.

About Novartis

Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease.

In the UK, we champion health and lives through pioneering NHS partnerships, innovative collaborations and a clear focus on the greatest healthcare challenges we all face. We are where science meets hope.

To reimagine medicine with us, visit our website at https://www.novartis.com/uk-en/ and connect on LinkedIn, Facebook, and Instagram.

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FA-11530711 | November 2025