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Novartis advanced breast cancer treatment approved in Scotland

Novartis’ Kisqali® (ribociclib) in combination with fulvestrant receives recommendation from Scottish Medicines Consortium as advanced breast cancer treatment for patients with the most common form of the disease.

Novartis has announced that, following appraisal by the Scottish Medicines Consortium (SMC), Kisqali® (ribociclib) a CDK4/6 inhibitor, in combination with fulvestrant (an endocrine (hormone) therapy), has been made available for routine use on NHS Scotland for post-menopausal women living with the most common form of advanced breast cancer.

The treatment combination is available for women with HR+/HER2- (hormone receptor positive, human epidermal growth factor receptor-2 negative) advanced breast cancer that is locally advanced or has spread to other areas of the body (metastatic). Women who have received prior hormone therapy are also eligible to access this new treatment.

In Scotland, breast cancer accounts for 28.8% of all cancers diagnosed, with 1 in 8.5 women developing breast cancer in their lifetime. HR+/HER2- locally advanced or metastatic breast cancer is the most common form of advanced breast cancer. For women with this incurable disease, the new treatment combination could give them the possibility of living five months longer without their disease worsening.

“Ribociclib in combination with fulvestrant offers better therapy for women in Scotland who are affected by this incurable disease. Potentially delaying the need for more toxic chemotherapy, it provides control of the cancer for longer, whilst maintaining quality of life than can be achieved with endocrine therapy alone,” commented Professor David Cameron, University of Edinburgh and NHS Lothian.

The SMC decision follows the positive recommendation by the National Institute for Health and Care Excellence (NICE) in July 2019 for the same indication. The recommendation is based on the positive data from the MONALEESA-3 trial. The MONALEESA-3 primary report showed that ribociclib plus fulvestrant was effective for delaying the progression of HR+/HER2- advanced breast cancer in post-menopausal patients by 20.5 months compared with 12.8 months with fulvestrant and placebo alone.

A further analysis of this study recently presented at the European Society for Medical Oncology (ESMO), showed that ribociclib plus fulvestrant extended overall survival by reducing the relative risk of death by 28% vs. fulvestrant and placebo alone.

“The SMC recommendation is an important development for patients with advanced breast cancer who need additional treatment options that can maintain their quality of life, provide them with more time without disease progression and offer overall survival” said Mari Scheiffele, General Manager of Novartis Oncology UK & Ireland.