CHMP Recommends Novartis' Kisqali for Early Breast Cancer

Novartis' Kisqali (ribociclib) has received a significant endorsement from the European Medicines Agency’s human medicines committee to help reduce the risk of recurrence in patients with early breast cancer. The Committee for Medicinal Products for Human Use (CHMP) has recommended that Kisqali be used alongside an aromatase inhibitor for adults with hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative early breast cancer, including those at high risk of recurrence such as patients with node-negative disease.

This recommendation follows the recent approval of Kisqali by the US Food and Drug Administration for the same indication. The CHMP’s decision is backed by positive outcomes from the advanced NATALEE trial. The trial demonstrated that adjuvant Kisqali combined with endocrine therapy reduced the chances of cancer recurrence by 25.1% compared to endocrine therapy alone in patients with HR-positive/HER2-negative stage 2 and 3 early breast cancer. The data highlighted a consistent and significant invasive disease-free survival (iDFS) benefit across key subgroups pre-identified in the trial.

An updated analysis of the NATALEE trial, which was presented at the European Society for Medical Oncology Congress, indicated that the iDFS benefit continued to deepen beyond the three-year treatment period across all patient groups. Breast cancer remains the most commonly diagnosed cancer in Europe, with HR-positive/HER2-negative disease representing around 70% of all cases.

Kisqali is already approved in the European Union for certain advanced or metastatic breast cancer cases. The drug works by inhibiting CDK4/6 proteins, which are known to be over-activated in some cancer cells, leading to rapid and uncontrolled cell division. The European Commission is now set to review the CHMP’s recommendation, with a final decision expected within roughly two months.

Patrick Horber, International President at Novartis, emphasized the importance of this development. He noted that many individuals diagnosed with HR-positive/HER2-negative early breast cancer in Europe currently have limited options beyond endocrine therapy to reduce the risk of recurrence. If Kisqali is approved, it could almost double the number of patients eligible for CDK4/6 inhibitor adjuvant therapy.

Novartis has also indicated that reviews for Kisqali as an early breast cancer treatment are ongoing worldwide. This international regulatory activity underscores the global importance and potential impact of Kisqali on improving outcomes for early breast cancer patients.

With breast cancer being such a prevalent diagnosis and HR-positive/HER2-negative cases forming a significant portion of these diagnoses, the approval of Kisqali for early breast cancer could mark a substantial advancement in treatment options. The ability to reduce recurrence risk effectively and enhance disease-free survival is critical for improving the quality of life and long-term outcomes for breast cancer patients. The final decision from the European Commission will be highly anticipated, as it represents a potential step forward in the battle against early-stage breast cancer.