Novartis' Kisqali reduces risk of death by 19.1% in 6-year breast cancer study

Novartis (NVS) reported positive 6-year trial results for its breast cancer drug, Kisqali, showing improved survival rates and lasting benefits from treatment (1).

• The study, the Phase III NATALEE trial of Kisqali (ribociclib), followed patients with stage II and III HR+/HER2- early breast cancer at high risk of recurrence.
• 5,101 adults from 20 countries participated, with varying levels of lymph node involvement (high-risk node-negative and node-positive breast cancer).
• At 6 years of follow-up, those receiving Kisqali and hormone therapy had a 19.1% lower risk of death, compared to those receiving only hormone therapy.
• These survival benefits were seen across key patient subgroups, and the overall survival benefit increased from 1.2 percentage points at 5 years to 2.1 percentage points at 6 years. The risk of breast cancer-specific death was reduced by about 29%, compared to hormone therapy alone.
• Additionally, the study didn't identify any new safety concerns during the extended follow-up period.
• 3% of patients receiving Kisqali with hormone therapy developed new, separate cancers, compared to 3.3% of those receiving only hormone therapy.
• The company plans to present the findings at the European Society for Medical Oncology's (ESMO) annual meeting, held over the next few days in Madrid.
• Novartis has already received approval for Kisqali in over 100 countries, including the U.S. and EU, for certain breast cancer indications.
• In FY2025, Novartis did about $4.8B in Kisqali sales, up 58% YoY. 2026 sales are expected to reach about $7B, its CEO said (2, 3).

Sources & Further Reading

1. "Kisqali shows clinically meaningful overall survival in broadest HR+/HER2- early breast cancer population at high risk of recurrence." Novartis. October 23, 2026.
2. "Full year 2025 product sales." Novartis. 2025.
3. "FDA’s extended approval of breast cancer drug is a ‘landmark’ for Novartis, CEO says." CNBC. September 18, 2026.