FDA Approves Ribociclib with an Aromatase Inhibitor for Early High-Risk Breast Cancer

On September 17, 2024, the FDA approved ribociclib (Kisqali, Novartis Pharmaceuticals Corporation) in combination with an aromatase inhibitor to treat adults with hormone receptor-positive, HER2-negative early breast cancer at high risk of recurrence. A co-package containing ribociclib and letrozole (Kisqali Femara Co-Pack) was also approved for the same indication.

The approval is based on the findings of the NATALEE trial (NCT03701334), a randomized, open-label, multicenter study that assessed the efficacy of ribociclib in combination with a nonsteroidal aromatase inhibitor (NSAI). The study included 5101 people with hormone receptor-positive, HER2-negative early breast cancer, the majority of whom had lymph node involvement. The FDA’s decision follows strong evidence of ribociclib’s ability to reduce the risk of breast cancer recurrence.

Novartis will benefit significantly from this approval, as ribociclib has demonstrated statistically significant improvements in invasive disease-free survival (iDFS). At 36 months, patients receiving ribociclib in combination with NSAI showed a 90.7% iDFS compared to 87.6% in the NSAI-only group. Ribociclib is expected to strengthen Novartis’ oncology portfolio and further its position in breast cancer treatment.