Novartis has announced that Kisqali® (ribociclib) has received authorisation from the European Commission for the treatment of advanced breast cancer and is now awaiting NICE’s decision on whether the drug will be funded via the NHS.
Ribociclib is now licensed for use in Europe as a first-line treatment in combination with an aromatase inhibitor in postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) locally advanced or metastatic breast cancer.
Ribociclib can be used in combination with letrozole, anastrozole or exemestane. This gives oncologists the discretion to select the therapy they believe is most appropriate for each individual patient.
The EU licence follows a positive opinion granted in June by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency, which was based on the superior efficacy and an acceptable safety profile of Kisqali plus letrozole versus placebo plus letrozole in the pivotal Phase III MONALEESA-2 trial.
More than half of patients (55%) with measurable disease taking ribociclib plus letrozole experienced a tumour size reduction of at least 30%.
In the UK, around 55,000 women are diagnosed with breast cancer each year. 30% of women with earlier stages of breast cancer will develop advanced disease, which is responsible for 90% of all breast cancer-related deaths. 85% of women diagnosed with advanced breast cancer will not live longer than five years.
Barak Palatchi, General Manager of Novartis Oncology UK & Ireland, said: “The new NICE process to assess funding cancer medicines on the NHS is a welcome development and we are working closely with NICE to ensure eligible patients in England and Wales have access to ribociclib at the earliest opportunity.”