Novartis: authorisation from European Commission

(CercleFinance.com) - Novartis announced that the European Commission (EC) has approved Kisqali (ribociclib) in combination with an aromatase inhibitor (AI) for the adjuvant treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer (EBC) patients at high risk of recurrence.


Approval is based on the results of the pivotal Phase III NATALEE trial, which included a large population of patients with HR+/HER2- Stage II and III early breast cancer, including those with node-negative disease.

The benefit in terms of invasive disease-free survival (iDFS) was consistently observed across all patient subgroups.

For many patients diagnosed with HR+/HER2- stage II or III early breast cancer, the risk of cancer recurrence despite endocrine therapy remains high, even after decades, said the Chairman of the Austrian Breast and Colorectal Cancer Study Group.

This approval represents a positive step for the early breast cancer community in Europe, including physicians who now have a new option to help reduce the risk of recurrence in a wider patient population. '


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