Novartis får ett positivt yttrande från CHMP för Kisqali

Novartis får ett positivt yttrande från CHMP för Kisqali för att hjälpa till att minska risken för återfall hos personer med HR+/HER2- tidig bröstcancer.

• If approved, patients in Europe with stage II or III HR+/HER2- early breast cancer (EBC) at high risk of recurrence, including those with node-negative disease, will be eligible for adjuvant treatment with Kisqali^® (ribociclib) in combination with an aromatase inhibitor¹
• Recommendation is based on the Phase III NATALEE trial, where Kisqali added to endocrine therapy (ET) significantly reduced the risk of recurrence by 25% versus ET alone across a broad population of patients with HR+/HER2- early breast cancer ²
• People with stage II or III HR+/HER2- EBC face significant risk of recurrence – often as incurable metastatic disease – despite adjuvant ET and regardless of nodal involvement^3,4
• In September, Kisqali was approved by the FDA in this setting⁵; at ESMO 2024, an updated analysis from NATALEE was presented, showing a deepening invasive disease-free survival benefit⁶

Novartis announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion and recommended granting marketing authorization for Kisqali^® (ribociclib) for the adjuvant treatment of adults with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer (EBC), at high risk of disease recurrence, including those with node-negative disease¹.

“One-third of people diagnosed with stage II breast cancer and more than half of those diagnosed with stage III will unfortunately experience a return of their cancer in the long term, often as metastatic disease,” said Peter A. Fasching, M.D., Professor of Translational Medicine, University Hospital Erlangen and Comprehensive Cancer Center Erlangen-EMN and NATALEE trial investigator. “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.”

Breast cancer is the most commonly diagnosed cancer in Europe⁷. HR+/HER2- is the most common subtype, accounting for approximately 70% of all breast cancers, and more than 40% of these are diagnosed in stage II or III^8-10.

The positive CHMP decision is based on robust data from the Phase III NATALEE trial^2,11,12. In the trial, Kisqali plus endocrine therapy (ET), compared to ET alone, lowered the risk of cancer recurrence by 25.1% in patients with stage II and III HR+/HER2- EBC (HR=0.749; 95% CI: 0.628, 0.892; P=0.0006) and demonstrated a consistent, clinically meaningful invasive disease-free survival (iDFS) benefit across key pre-specified subgroups^2,11. Data from the pivotal trial also showed the safety profile of Kisqali at the 400mg dose was well-tolerated with generally low-grade symptomatic adverse events^2,11.

An updated analysis from the NATALEE trial recently presented at the European Society for Medical Oncology (ESMO) Congress 2024 adds to the growing body of evidence supporting the potential of Kisqali to consistently reduce risk of recurrence across a broad population⁶. In the updated analysis, the iDFS benefit continued to deepen beyond the three-year Kisqali treatment period in all patient subgroups, including those with node-negative disease².

“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,” said Patrick Horber M.D., President, International, Novartis. “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.”

Following the CHMP’s recommendation to approve Kisqali in a broad population of patients diagnosed with HR+/HER2- EBC at high risk of recurrence, the European Commission (EC) will take a final decision within approximately two months.

Kisqali was developed by Novartis under a research collaboration with Astex Pharmaceuticals.