The European Commission he approved ribociclib in combination with an aromatase inhibitor (AI) for treatment in the adjuvant phase of patients with early breast cancer (EBC) hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-), at high risk of recurrence.
The approval is based on results from the pivotal phase III NATALEE study, which included a large population of patients with stages II and III HR+/HER2- early breast cancer, including those without lymph node involvement.
The study showed a significant and clinically relevant reduction of 25.1% (HR=0.749; 95% CI: 0.628, 0.892; P=0.0006) of the risk of disease recurrence with ribociclib plus endocrine therapy (ET) compared to ET alone. Invasive disease-free survival (iDFS) benefit was observed consistently across all patient subgroups.
Ribociclib is a selective inhibitor of cyclin-dependent kinasesa class of drugs that helps slow the progression of cancer by inhibiting two proteins called cyclin-dependent kinases 4 and 6 (CDK4/6).
“For many patients diagnosed with stage II or III HR+/HER2- early breast cancer, the risk of disease recurrence, despite treatment with endocrine therapy, remains substantial, even after decades,” he notes Michelino De Laurentiis, director of SC Experimental Clinical Oncology of Senology of the National Institute for the Study and Treatment of Tumors “Giovanni Pascale Foundation”, “This approval represents a milestone for the European community with a new therapeutic option to reduce the risk of relapse in a large patient population. This is encouraging news for both doctors and patients, including those without lymph node involvement, but with at least one additional risk factor.”
“The prospect of breast cancer recurrence can be a source of concern for those diagnosed early. At Novartis we are committed to ensuring that patients have access to treatment options that help minimize the risk of recurrence,” he notes Paola Coco, Medical Affairs Head of Novartis Italia. “We are proud of this approval, which will help respond to an important unmet medical need and improve and prolong life in an increasingly large population of patients in Europe and Italy.”
EC approval follows that of FDA regarding ribociclib for patients with early breast cancer and the recommendation as a preferential Category 1 adjuvant treatment in the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology* (NCCN Guidelines).
Ribociclib also achieved the highest score (A) in the European Society for Medical Oncology-Magnitude of Clinical Benefit Scale (ESMO-MCBS) for EBC
Following the presentation of recent data at ESMO 2024, Novartis will continue to evaluate the outcomes of patients involved in the long-term NATALEE study, including overall survival.
**How does the mechanism of action of ribociclib, as a selective CDK4/6 inhibitor, contribute to its effectiveness in reducing the risk of breast cancer recurrence?**
## A New Weapon Against Breast Cancer: European Commission Approves Ribociclib For High-Risk Early Breast Cancer Patients
**In a significant victory for breast cancer patients, the European Commission has approved ribociclib, in combination with an aromatase inhibitor (AI), for adjuvant treatment of early breast cancer (EBC). This crucial approval targets patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) EBC at high risk of recurrence.**
This news follows the successful results of the pivotal phase III NATALEE study, which enrolled a large and diverse patient population diagnosed with stages II and III HR+/HER2- early breast cancer. The study encompassed individuals with and without lymph node involvement, reflecting the real-world complexity of this disease.
**Promising Results Show Significant Reduction in Recurrence Risk**
The NATALEE study demonstrated a **clinically meaningful reduction in the risk of disease recurrence** for patients receiving ribociclib plus endocrine therapy (ET) compared to those receiving ET alone.
* **A 25.1% reduction in the risk of disease recurrence** was observed in patients treated with the ribociclib combination (HR=0.749; 95% CI: 0.628, 0.892; P=0.0006)
* This benefit in **invasive disease-free survival (iDFS)** was consistent across all patient subgroups within the study.
**Targeting Cancer Growth with Ribociclib’s Unique Mechanism**
Ribociclib belongs to a class of drugs known as **selective cyclin-dependent kinases (CDK4/6) inhibitors**. These drugs work by inhibiting the activity of CDK4 and CDK6, two proteins crucial for the uncontrolled cell proliferation that drives cancer growth.
By blocking CDK4/6, ribociclib slows down the progression of cancer cells, improving outcomes for patients.
**Hope for Improved Outcomes and Quality of Life**
The European Commission’s approval of ribociclib signifies a major step forward in the fight against early breast cancer. This targeted therapy promises to offer high-risk patients a valuable new tool to reduce their risk of disease recurrence and enhance their long-term outcomes.
**Further research and clinical trials will continue to explore the full potential of ribociclib in the broader context of breast cancer treatment, paving the way for improved survival rates and enhanced quality of life for patients.**
