EC approves Novartis' Kisqali for early breast cancer treatment

The European Commission (EC) has approved Novartis' drug Kisqali (ribociclib) for use in a broad range of early breast cancer patients to mitigate the risk of disease recurrence. This approval is for combining Kisqali with an aromatase inhibitor as an adjuvant treatment in patients who have hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer that is at high risk of coming back.

This decision from the EC follows a recent recommendation from the European Medicines Agency’s human medicines committee. The approval was influenced by positive data from the late-stage NATALEE trial. This trial included a diverse group of patients with HR-positive/HER2-negative stage 2 and 3 early breast cancer, even those with node-negative disease. The trial results indicated that using Kisqali in addition to endocrine therapy reduced the risk of disease recurrence by 25.1% when compared to using endocrine therapy alone. The findings also showed consistent benefits across all patient subgroups concerning invasive disease-free survival.

Breast cancer is frequently diagnosed in its early stages, with about 70% of cases being early-stage upon detection. Despite current treatments, patients with HR-positive/HER2-negative stage 2 and 3 early breast cancer still face the risk of disease recurrence over time. Kisqali is designed to block the activity of CDK4/6 proteins, which can accelerate the growth and division of cancer cells when overly active. The drug is already approved in the European Union for specific advanced or metastatic breast cancer cases.

Iris Zemzoum, President of Novartis Europe, emphasized the importance of providing treatment options that reduce the risk of cancer recurrence and offer peace of mind to patients. She stated, "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."

This authorization by the EC comes shortly after Novartis entered into a global licence and collaboration agreement valued at $745 million with Ratio Therapeutics. This agreement aims to advance a radiotherapeutic candidate targeting the somatostatin receptor 2 for cancer treatment. Additionally, earlier this month, Novartis signed a research collaboration and licence agreement with Schrödinger worth over $2.4 billion. This collaboration focuses on identifying and advancing multiple drug candidates for development and commercialization.

In summary, the EC's approval of Kisqali for early breast cancer patients marks a significant advancement in addressing the risk of disease recurrence. The decision, backed by robust clinical trial data, supports the use of Kisqali in combination with endocrine therapy for improved patient outcomes. This approval is part of Novartis' broader efforts to develop innovative treatments and collaborations aimed at improving cancer care and patient health worldwide.