Novartis’ Kisqali® (ribociclib) receives NICE recommendation for routine funding as second-line treatment of hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer
Advanced breast cancer is an incurable disease - in the UK 85% of women with metastatic breast cancer will not survive for 5 years or more after diagnosis.1
The new NICE guidance follows an updated analysis from the MONALEESA-3 study in which Kisqali plus fulvestrant achieved statistically significant overall survival benefit vs. fulvestrant alone in postmenopausal women (HR=0.724; p=0.00455).2
Kisqali (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).3
Ribociclib plus fulvestrant is recommended as an option for treating hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer in adults who have had previous endocrine therapy only if:
exemestane plus everolimus is the most appropriate alternative to a cyclin- dependent kinase 4 and 6 (CDK 4/6) inhibitor, and
the company provides ribociclib according to the commercial arrangement.4
London, UK, 26 February 2021 – Novartis today welcomed the news that the National Institute for Health and Care Excellence (NICE) has recommended 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.4
In the UK, around 55,000 women are diagnosed with breast cancer each year.5 30% of women with earlier stages of breast cancer will develop advanced disease.6 85% of women diagnosed with advanced breast cancer will not live longer than 5 years.1
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.7
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.2
“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.” Said Dr Duncan Wheatley, Royal Cornwall Hospital NHS Trust. “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.”
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.8 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. A CDF recommendation only has temporary status and allows for newer treatments to be accessed while further data is collected to address clinical uncertainty.9
“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.” Commented Mari Scheiffele, Novartis Oncology General Manager, UK & Ireland. “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.”
Notes to Editors
About Kisqali® (ribociclib)3
Kisqali® (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 rapidly. Targeting CDK4/6 with enhanced precision may play a role in ensuring that cancer cells do not continue to replicate uncontrollably.
Ribociclib is already approved for use in the UK for the treatment of women with HR+/HER2- 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 luteinising hormone-releasing hormone (LHRH) agonist.
Ribociclib can be taken with or without food as a once-daily oral dose of 600 mg (three 200 mg tablets) for three weeks, followed by one week off treatment. Ribociclib is taken in combination with four weeks of any aromatase inhibitor, or with 500 mg of fulvestrant that should be given by intramuscular injection on Days 1, 15, 29, and once monthly thereafter Please refer to the SmPC of ribociclib for additional details.7
MONALEESA-3 was a randomised, double-blind, placebo-controlled, multi-centre, phase III trial in postmenopausal women with HR+/HER2- mBC who received no or only 1 prior line of endocrine therapy for advanced or metastatic disease. Patients (N=726) were stratified by the presence of liver and/or lung metastases and prior endocrine therapy for advanced or metastatic disease. Patients were randomised (2:1) to receive either KISQALI 600 mg (3 weeks on, 1 week off) and fulvestrant 500 mg (intramuscular injection on Days 1, 15, 29, and once monthly thereafter) or placebo (3 weeks on, 1 week off) and fulvestrant 500 mg (intramuscular injection on Days 1, 15, 29, and once monthly thereafter). The primary end point was PFS using RECIST v1.1; secondary end points included OS, ORR, QOL, and safety.
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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.
O'Shaughnessy J. Extending survival with chemotherapy in metastatic breast cancer. The Oncologist. October 2005, 10(suppl.): 20-29.
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.