NICE has recommended a new life-extending drug combination for patients with advanced breast cancer in draft guidance that could benefit thousands of women.

Ribociclib (Kisqali) in combination with fulvestrant for women with prior endocrine therapy will be made available for routine use on the NHS for the treatment of a type of breast cancer called hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer.

The combination is recommended for adults who have had previous endocrine therapy and where exemestane plus everolimus is the most appropriate alternative treatment.

Taken once-daily in pill form, ribociclib is a cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor. These work by inhibiting proteins in cancer cells, thereby preventing the cells from dividing and growing. 

The committee heard from patients that they value improvements in progression-free survival and want to delay chemotherapy for as long as possible. They also heard that the different side effects of each of the CDK4/6 inhibitors, which are generally less toxic than the combination of exemestane and everolimus, mean that people would like to have a range of treatment options available to them.

Meindert Boysen, deputy chief executive and director of the NICE Centre for Health Technology Evaluation, said: “Treatments that can postpone disease progression are important because they can mean some people can avoid the often unpleasant side-effects of chemotherapy, and delay the need for its use in others.

“We are pleased therefore that our original decision to make ribociclib available through the CDF not only gave people access to it earlier than would otherwise have been possible, but has now, through the data collected during that time, allowed us to recommend it for routine use on the NHS.” 

Ribociclib has been available through the CDF since 2019 while more evidence was collected to address uncertainties around how much it extends overall survival and its cost-effectiveness.

Nearly a third of breast cancer patients develop advanced disease

In the UK, around 55,000 women are diagnosed with breast cancer each year and 30% of women with earlier stages of breast cancer will develop advanced disease. Of these, 85% will not live longer than five years.

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.

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.

Dr 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.”

Subject to appeal, NICE’s final guidance will be published in March 2021.