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NICE greenlights Novartis Kisqali combo in HR+/HER2- advanced breast cancer

Published on 17/07/19 at 10:52am

Novartis’ Kisqali (ribociclib) has secured recommendation from NICE in combination with fulvestrant, meaning the cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor will be immediately made available on the NHS.

The drug will be accessible to an estimated 5,300 patients a year in England and Wales, where exemestane plus everolimus is the most appropriate alternative, as a treatment for women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) locally advanced or metastatic breast cancer who have received prior endocrine therapy.  

Advanced breast cancer is incurable, with survival for 85% of patients not extending beyond five years.

“Treatments that can postpone disease progression are important because they can reduce the number of people who are exposed to the often unpleasant side-effects of chemotherapy, and delay the need for its use in others,” Meindert Boysen, Director of the NICE Centre for Health Technology Evaluation, said. !“We are pleased therefore that the company has agreed a commercial arrangement for ribociclib that will allow it to be made available to people with this type of breast cancer.” 

This latest recommendation was based on data demonstrating that the Kisqali combo improved median progression-free survival by 20.5 months compared to 12.8 months with placebo in first- and second-line post-menopausal patients with HER2- advanced breast cancer.

“Here at the Northern Centre for Cancer Care, we took part in the MONALEESA-3 trial that established the efficacy of this combination treatment” said Dr Mark Verrill, Consultant Medical Oncologist. “Ribociclib is already approved alongside an aromatase inhibitor as first treatment for metastatic breast cancer.  However, until very recently, we were unable to offer ribociclib or another drug of the same type to women who had already received an aromatase inhibitor and it had stopped working. This restriction meant that around half of the patients who might benefit from ribociclib could not receive it. It is a vital step forward to be able to offer ribociclib in combination with fulvestrant after an aromatase inhibitor and I anticipate many women benefitting from this approval. Helping women with this incurable disease by controlling it for longer and maintaining quality of life is a significant step forward.”

Matt Fellows

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