Novartis on Friday announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion and recommended granting marketing authorization for Kisqali (ribociclib).
According to the company’s press statement, the drug was recommended for 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 A. Fasching, M.D., 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.”
Breast cancer is the most commonly diagnosed cancer in Europe. HR+/HER2- is the most common subtype, accounting for approximately 70% of all breast cancers, and more than 40% of these are diagnosed in stage II or III8-10. According to Novartis, the positive CHMP decision is based on robust data from the Phase III NATALEE trial.
“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 M.D., 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.”
Following the CHMP’s recommendation to approve Kisqali in a broad population of patients diagnosed with HR+/HER2- EBC at high risk of recurrence, the European Commission (EC) will take a final decision within approximately two months, it stated.
