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Novartis Seeks Adjuvant Kisqali Approval After Phase III Readout in Early-Stage Breast Cancer

NEW YORK – Novartis said on Monday that it is in the process of global regulatory submissions for its CDK4/6 inhibitor Kisqali (ribociclib) plus endocrine therapy as adjuvant treatment for early-stage, hormone receptor-positive, HER2-negative breast cancer patients who are at risk of their cancers relapsing.

The drugmaker said that Kisqali met its primary endpoint of invasive disease-free survival in the Phase III NATALEE trial, in which patients were randomized to receive either Kisqali plus endocrine therapy or endocrine therapy alone.

The CDK4/6 inhibitor significantly reduced patients' risk of disease recurrence, leading an independent data-monitoring committee to recommend stopping the trial early. According to Novartis, the benefit was consistent in patients with both stage II and stage III early breast cancer regardless of nodal involvement.

Novartis investigators will continue to evaluate long-term outcomes, including overall survival, among patients treated on the NATALEE trial.

"These data have the potential to be paradigm-shifting for patients at risk of recurrence, including those with no nodal involvement, who have limited well-tolerated options to prevent recurrence," Shreeram Aradhye, Novartis' chief medical officer and president of global drug development, said in a statement. "Our teams are working on submissions to health authorities around the world with the hope to bring Kisqali to many more patients diagnosed with breast cancer."

Kisqali is already approved in combination with an aromatase inhibitor or fulvestrant for advanced or metastatic hormone receptor-positive, HER2-negative breast cancer patients. Recently, the National Comprehensive Cancer Network updated its guidelines to recommend the therapy as a category 1 frontline treatment option.