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CHMP Recommends Approving Kisqali as Adjuvant Treatment for Early-Stage HER2-Negative Breast Cancer

NEW YORK – The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) on Friday said it would recommend marketing authorization for Novartis' CDK4/6 inhibitor Kisqali (ribociclib) with an aromatase inhibitor as an adjuvant treatment for hormone receptor (HR)-positive HER2-negative early breast cancer patients.

If approved by the European Commission, Kisqali would become available for patients with stage II or III HR-positive HER2-negative early breast cancer at high risk of recurrence, including patients with node-negative disease. The EC is expected to make a final decision on approval in approximately two months.

The CHMP opinion was based on results from the Phase III NATALEE trial, in which researchers compared adjuvant Kisqali plus endocrine therapy against endocrine therapy alone. The addition of Kisqali to the adjuvant regimen lowered the risk of cancer recurrence by 25.1 percent in these early-stage breast cancer patients. Kisqali also demonstrated a benefit in invasive disease-free survival versus endocrine therapy alone, with three-year invasive disease-free survival rates of 90.4 percent and 87.1 percent, respectively.

Last month, the US Food and Drug Administration approved Kisqali in this same indication. The drug is also approved in Europe for HR-positive HER2-negative advanced or metastatic breast cancer in combination with either an aromatase inhibitor or fulvestrant as initial endocrine-based therapy or after disease progression.

"If approved, Kisqali could nearly double the number of patients eligible for CDK4/6 inhibitor adjuvant therapy," Patrick Horber, international president at Novartis, said in a statement. "Together with the recent FDA approval and late-breaking NATALEE data presented at [the European Society for Medical Oncology Congress], 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."