The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended granting marketing authorisation for Novartis’ Kisqali (ribociclib). 

The positive opinion relates to the adjuvant treatment of adults with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer (EBC), at high risk of disease recurrence, including those with node-negative disease. 

“One-third of people diagnosed with stage II breast cancer and more than half of those diagnosed with stage III will unfortunately experience a return of their cancer in the long term, often as metastatic disease,” said Peter Fasching, Professor of Translational Medicine, University Hospital Erlangen and Comprehensive Cancer Center Erlangen-EMN and NATALEE trial investigator. “If approved, Kisqali could provide an effective and tolerable adjuvant treatment option to mitigate the risk of recurrence in a broader patient population, particularly for patients who currently have limited treatment options, including those with high-risk node-negative disease.” 

HR+/HER2- is the most breast cancer common subtype, accounting for approximately 70% of all breast cancers, and more than 40% of these are diagnosed in stage II or III. 

25% lower risk of cancer recurrence 

The CHMP decision is based on data from the Phase III NATALEE trial, in which Kisqali plus endocrine therapy (ET), compared to ET alone, lowered the risk of cancer recurrence by 25.1% in patients with stage II and III HR+/HER2- EBC. 

An updated analysis from the NATALEE trial presented at the European Society for Medical Oncology (ESMO) Congress 2024 showed that the invasive disease-free survival (iDFS) benefit continued beyond the three-year Kisqali treatment period in all patient subgroups. 

“Today, many people diagnosed with HR+/HER2- early breast cancer in Europe lack options beyond endocrine therapy to help reduce their risk of cancer coming back. If approved, Kisqali could nearly double the number of patients eligible for CDK4/6 inhibitor adjuvant therapy,” said Patrick Horber President, International, Novartis. “Together with the recent FDA approval and late-breaking NATALEE data presented at ESMO, today’s positive CHMP recommendation further reinforces the differentiated profile of Kisqali as a new treatment option for a broad population of patients, including those with node-negative disease.” 

The European Commission (EC) will make a final decision within approximately two months.