FDA Approves Ribociclib for Early HR+/HER2- Breast Cancer Based on NATALEE Trial Results

Key Insights

• The FDA has approved ribociclib (Kisqali) in combination with endocrine therapy for adjuvant treatment of HR+/HER2- early breast cancer, based on the Phase III NATALEE trial.
• The NATALEE trial demonstrated a 25.1% reduction in recurrence risk in patients receiving ribociclib plus endocrine therapy compared to endocrine therapy alone.
• The approval marks a significant advancement, extending the use of CDK4/6 inhibitors to early-stage breast cancer to improve disease-free survival.

The FDA has granted approval to ribociclib (Kisqali) in conjunction with endocrine therapy for the adjuvant treatment of adult patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer. This decision stems from the Phase III NATALEE trial, a global study involving participants from 20 countries, including the Comprehensive Cancer Centers of Nevada.

The NATALEE trial's findings revealed a clinically significant 25.1% reduction in the risk of cancer recurrence among patients with stage II and III HR+/HER2- early breast cancer who received adjuvant ribociclib alongside endocrine therapy, compared to those treated with endocrine therapy alone. This approval expands the application of CDK4/6 inhibitors to early-stage breast cancer, offering the potential to improve disease-free survival rates.

NATALEE Trial Details

The Phase III NATALEE trial enrolled 5,100 participants globally, with 14 local patients participating through the Comprehensive Cancer Centers of Nevada. Valerie Derrick, a local resident diagnosed with stage 3 breast cancer in 2019, participated in the trial. Her treatment included a double mastectomy and reconstruction, chemotherapy, radiation, and the removal of her ovaries. She has been off the drug for two years with no recurrence.

Dr. Stephani Christensen from the Comprehensive Cancer Centers of Nevada emphasized the importance of this approval, stating, "This approval is significant because now we can use these inhibitors in early-stage breast cancers and improve disease-free survival."

Clinical Significance

The approval of ribociclib represents a notable advancement in the treatment landscape for early-stage HR+/HER2- breast cancer. By incorporating a CDK4/6 inhibitor into the adjuvant setting, clinicians can now offer a more effective strategy to reduce the risk of recurrence in patients with high-risk disease. The NATALEE trial's results underscore the potential for improved outcomes and highlight the value of clinical trial participation in driving medical progress.