Novartis: FDA approval in breast cancer

(CercleFinance.com) - Novartis announces that the US FDA has approved its drug Kisqali, in combination with an aromatase inhibitor, for the adjuvant treatment of stage II and III HR+/HER2- early breast cancer patients at high risk of recurrence.


This approval is based on the pivotal Phase III NATALEE trial, which showed that Kisqali reduced the risk of recurrence by 25% compared to endocrine therapy alone, with a consistent benefit and well-tolerated safety profile observed in all subgroups.

Novartis also points out that late-breaking data presented at ESMO showed an increased benefit in invasive disease-free survival after the end of the three-year treatment period in all patient subgroups.


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