Novartis’ Kisqali (ribociclib) has been approved by the European Commission (EC) to reduce the risk of disease recurrence in a broad population of early breast cancer patients.
The drug has been authorised for use in combination with an aromatase inhibitor as an adjuvant treatment for patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer at high risk of recurrence.
The regulator’s decision follows a recent recommendation from the European Medicines Agency’s human medicines committee and was based on positive results from the late-stage NATALEE trial, which included a broad patient population with HR-positive/HER2-negative stage 2 and 3 EBC, including those with node-negative disease.
Adjuvant Kisqali plus endocrine therapy reduced the risk of disease recurrence by 25.1% compared to endocrine therapy alone, and demonstrated a consistent invasive disease-free survival benefit across all patient subgroups.
Approximately 70% of breast cancer cases are diagnosed in the early stages of the disease and, despite current treatment options, those with HR-positive/HER2-negative stage 2 and 3 early breast cancer remain at risk of experiencing disease recurrence in the long term.
Novartis’ Kisqali is designed to inhibit the CDK4/6 proteins which, when over-activated, can enable cancer cells to grow and divide too quickly, and is already approved in the EU for certain cases of advanced or metastatic breast cancer.
Iris Zemzoum, president, Europe, Novartis, said: “Patients deserve access to treatment options that help minimise the risk of their cancer coming back and put their mind at ease.
“We are proud of this approval, which will help to address a key unmet need and improve health outcomes for a broader population of patients in Europe.”
The authorisation comes less than two weeks after Novartis entered into a worldwide licence and collaboration agreement worth $745m with Ratio Therapeutics to advance a somatostatin receptor 2-targeting radiotherapeutic candidate for cancer.
The company also entered into a research collaboration and licence agreement worth over $2.4bn with Schrödinger earlier this month to identify and advance multiple drug candidates for it to develop and commercialise.