Novartis' Kisqali (ribociclib), when combined with endocrine therapy (ET), has demonstrated a significant reduction in the risk of recurrence for patients with stage II or III HR+/HER2- early breast cancer. The updated analysis of the Phase 3 clinical trial revealed a 28.5% reduction in recurrence risk compared to ET alone, showcasing a deepening benefit beyond the three-year treatment period.
Trial investigator Dr. Peter Fasching emphasized the importance of these findings, noting that patients with this form of breast cancer face a substantial risk of the cancer returning as metastatic disease. Clinicians have been actively seeking new ways to address this risk, and the results of this trial offer a promising new treatment option for a broad range of patients at risk of recurrence.
Regulatory Submissions and Anticipated Approval
Novartis has already submitted the results of the Phase 3 clinical trial to both the Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The company anticipates a decision from the FDA regarding approval of the treatment this quarter. This regulatory action could potentially provide a new standard of care for patients with HR+/HER2- early breast cancer.
Impact on Novartis
The positive news from the Kisqali trial has had a noticeable impact on Novartis' stock. Novartis ADRs experienced a rise following the announcement of the trial results, reflecting investor confidence in the potential of Kisqali to improve outcomes for breast cancer patients.
