Swiss pharmaceutical company Novartis Pharma AG (SIX:NOVN) (NYSE:NVS) announced on Friday that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of Kisqali (ribociclib) for the adjuvant treatment of HR+/HER2- early breast cancer (EBC) at high risk of recurrence.

This recommendation is based on data from the Phase III NATALEE trial, which showed that Kisqali plus endocrine therapy (ET) reduced the risk of recurrence by 25.1% compared to ET alone.

"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 A. Fasching, M.D., Professor of Translational Medicine at 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."

The CHMP's positive opinion means that the European Commission could approve Kisqali for this indication within two months.