Novartis gets positive CHMP opinion for Kisqali in early breast cancer

This recommendation paves the way for a new therapy option for adults with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer (EBC) at high risk of recurrence.

This also includes those with node-negative disease.

The positive opinion from CHMP is based on the results from the Phase III NATALEE trial, which is a global, multi-centre, open-label study.

NATALEE trial investigator Peter Fasching said: “If approved, Kisqali could provide an effective and tolerable adjuvant treatment option to mitigate the risk of recurrence in a broader patient population, particularly for patients who currently have limited treatment options, including those with high-risk node-negative disease.”

The trial demonstrated that Kisqali, when used alongside endocrine therapy (ET), reduced the risk of cancer recurrence by 25.1% in patients with stage II and III HR+/HER2- EBC, compared to ET alone.

Additionally, Kisqali showed a consistent invasive disease-free survival (iDFS) benefit across various key subgroups.

The safety profile of Kisqali at the 400mg dosage was also highlighted as well-tolerated, with most adverse events being of low grade.

Breast cancer remains the most prevalent cancer in Europe, with HR+/HER2- being the most common subtype, representing around 70% of all cases.

Notably, over 40% of these cases are diagnosed at stage II or III.

Further evidence from an updated analysis presented at the European Society for Medical Oncology (ESMO) Congress in 2024 suggested that the iDFS benefit of Kisqali extends beyond the initial three-year treatment period across all patient subgroups, including those with node-negative disease.

Novartis MD president Patrick Horber said: “Today, many people diagnosed with HR+/HER2- early breast cancer in Europe lack options beyond endocrine therapy to help reduce their risk of cancer coming back. If approved, Kisqali could nearly double the number of patients eligible for CDK4/6 inhibitor adjuvant therapy.

“Together with the recent FDA approval and late-breaking NATALEE data presented at ESMO, 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.”

With the CHMP’s recommendation, the European Commission (EC) is expected to make a final decision on the approval of Kisqali for this broader patient population within the next two months.