NICE recommendation for Novartis’ Kisqali® in advanced breast cancer

NICE recommendation for Novartis’ ribociclib in advanced breast cancer

The National Institute for Health and Care Excellence (NICE) has recommended Novartis’ Kisqali (ribociclib) in combination with fulvestrant for women with prior endocrine therapy. It will be made available for routine use on the NHS for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in combination with fulvestrant in women who have received prior endocrine therapy.iv

This NICE recommendation is based on the latest data from the second line subpopulation of MONALEESA-3 clinical study where ribociclib plus fulvestrant demonstrated a median progression free survival (PFS) of 14.6 months vs 9.1 months with placebo plus fulvestrant. The second line subpopulation consisted of patients who had progressed after one line of endocrine treatment for advanced disease or relapsed while on, or within 12 months of completing, neoadjuvant or adjuvant endocrine therapy.vii

MONALEESA-3 is the largest trial to evaluate a CDK4/6 inhibitor plus fulvestrant as initial therapy in postmenopausal women (N=726). The trial included women with no prior endocrine therapy, including those diagnosed de novo, women who relapsed within 12 months of adjuvant therapy and women who progressed on endocrine therapy for advanced disease.ii

Kisqali in combination with an aromatase inhibitor for previously untreated, hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer has been routinely available on the NHS since 2017 in England and Wales.viii Until this new NICE recommendation, Kisqali in combination with fulvestrant for women with prior endocrine therapy had been funded via the Cancer Drugs Fund (CDF) since August 2019.

Duncan Wheatley, Royal Cornwall Hospital NHS Trust said: “This positive decision by NICE to provide routine commissioning of Kisqali in combination with fulvestrant in the second line setting as a standard of care on the NHS marks good news for those living with secondary breast cancer in the UK. Based on the pivotal results from the MONALEESA-3 study, the approval is an important move towards ensuring people living with this incurable condition have access to treatments where their disease can be controlled and their quality of life is supported.”

Mari Scheiffele, Novartis Oncology General Manager, UK & Ireland said: “The recommendation by NICE is a welcome development for people living with advanced breast cancer who require additional treatment options that can maintain their quality of life and provide them with more time without disease progression. Today’s NICE recommendation further demonstrates the value of Kisqali treatment for advanced breast cancer patients. In securing the routine NHS funding for Kisqali in combination with fulvestrant, we can help shift some of the uncertainty that patients may have been experiencing while ribociclib was only available through the CDF. As Novartis Oncology, we are pleased to have worked with NICE to secure access to Kisqali for all eligible patients.”


i Cancer Research UK [Online]. Breast cancer survival statistics. Available from: [Accessed February 2021].

ii Slamon, D.J. et al. Overall survival (OS) results of the phase III MONALEESA-3 trial of postmenopausal patients (pts) with hormone receptor-positive (HR+), human epidermal growth factor 2-negative (HER2−) advanced breast cancer (ABC) treated with fulvestrant (FUL) ± ribociclib (RIB). Annals of Oncology. October 2019, 30(Suppl 5), V856-V857.

iii Summary of Product Characteristics (SPC). emc website:

iv NICE FAD – February 2021

v Cancer Research UK [Online]. Breast cancer incidence (invasive) statistics. Available from: [Accessed February 2021].

vi O’Shaughnessy J. Extending survival with chemotherapy in metastatic breast cancer. The Oncologist. October 2005, 10(suppl.): 20-29.

vii Slamon, D., Neven, P., Chia, S., Fasching, P., De Laurentiis, M., Im, S., Petrakova, K., Bianchi, G., Esteva, F., Martín, M., Nusch, A., Sonke, G., De la Cruz-Merino, L., Beck, J., Pivot, X., Vidam, G., Wang, Y., Rodriguez Lorenc, K., Miller, M., Taran, T. and Jerusalem, G., 2018. Phase III Randomized Study of Ribociclib and Fulvestrant in Hormone Receptor–Positive, Human Epidermal Growth Factor Receptor 2–Negative Advanced Breast Cancer: MONALEESA-3. Journal of Clinical Oncology, 36(24), pp.2465-2472.

viii 2017. [online] Available at: <> [Accessed February 2021].

ix NICE. 2019. Breast cancer patients to have further NICE-approved drug combination option on Cancer Drugs Fund. [online] Available at: <> [Accessed February 2021].

x Slamon, D., 2021. Overall Survival with Ribociclib plus Fulvestrant in Advanced Breast Cancer | NEJM. [online] New England Journal of Medicine. Available at: <> [Accessed February 2021]