Today, Novartis China announced its重磅 breast cancer treatment product, Kaylilon.®(Ribociclib Succinate Tablets) have been approved by the National Medical Products Administration (NMPA) for a new indication, in combination with aromatase inhibitors, as adjuvant therapy for patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer at high risk of recurrence.*。
As the world's first and currently only approved for extensive Stage II-III**CDK4/6 Inhibitor for HR+/HER2- Breast Cancer Adjuvant Therapy (Including Some N0 Populations), Kaylilon®Will help more breast cancer patients in China reduce the risk of early recurrence and bring hope of a cure. This is also Kaililong®Another new indication approved in China besides the first-line treatment for advanced breast cancer.
Ian Lee, President and Managing Director of Novartis China, said: "Breast cancer is the "number one cancer" threatening the health of women globally and is also one of the key disease areas that Novartis focuses on. This time, Kaylilon...®The approval of adjuvant therapy indications for early-stage breast cancer, building on its first-line treatment for advanced breast cancer, further expands the eligible patient population, providing comprehensive coverage for both early and advanced breast cancer patients. This development offers the potential to help more breast cancer patients transition from "life extension" to the "possibility of cure." Moving forward, we will continue to uphold the belief of "Commitment to China," helping Chinese patients extend their lives and improve their quality of life through innovative therapies.”
The long-term risk of early breast cancer recurrence persists,Urgently Need Innovative Treatment Solutions
Breast cancer is not only the "number one cancer" threatening the health of women worldwide, but China has also become a country with a high incidence of breast cancer. Data shows that in 2022, there were 357,200 new cases of breast cancer in China, with the incidence rate ranking second among female malignant tumors.1, of which more than 95% of patients are diagnosed at an early stage.2HR+/HER2- early breast cancer can be cured, but up to one-third of patients will still experience recurrence or metastasis even after receiving conventional adjuvant endocrine therapy.3, progressing to an incurable disease.
The risk of breast cancer recurrence does not completely disappear over time, and patients with early-stage HR+ breast cancer face a peak of recurrence 3 years after surgery.4. Studies show that the status of lymph node metastasis, tumor size, and histological grade5,6Ki-67 Expression7(The proportion of Ki-67 positive cells in tumor tissue), multi-gene detection data8Various factors are associated with an increased risk of recurrence in HR+/HER2- early breast cancer. Real-world research data shows that for patients without lymph node metastasis but with high-risk factors, as well as those with lymph node metastasis, their risk of recurrence is three times higher than that of other early-stage patients, clearly indicating the unmet clinical needs of this population. Based on this, the pivotal Phase III NATALEE study of Ribociclib has selected a patient population that aligns with clinical needs. For these patients, regardless of lymph node status, it is essential to have thorough communication with their doctors to develop personalized treatment and follow-up plans to achieve the goal of cure.9。
Ribociclib Approved for Early Breast Cancer Indication,Help More Patients Reduce Recurrence and Move Towards Cure
The application of CDK4/6 inhibitors in adjuvant therapy for HR+/HER2- early breast cancer has reduced the risk of recurrence and metastasis in early-stage patients. The approval of Ribociclib is based on the NATALEE study. Compared with adjuvant endocrine therapy alone, Ribociclib adjuvant intensification therapy reduced the 4-year risk of breast cancer recurrence and distant metastasis by 28.5%. Consistent benefits were observed across all subgroups, including those without lymph node metastasis or with stage II disease, further demonstrating the sustained and broad benefits of Ribociclib adjuvant intensification therapy in patients with early breast cancer.10. At the same time, ribociclib adjuvant intensification therapy continued to reduce the risk of death compared with adjuvant endocrine therapy alone. In terms of safety, the adverse reaction profile of ribociclib was consistent with previous studies, with no new safety signals emerging, and most were grade 1-2 and non-perceptible toxicities. In terms of quality of life, the ribociclib intensification therapy group maintained consistency with the control group in quality of life scores, while 4-year follow-up data further demonstrated the good long-term tolerability of ribociclib.4NATALEE Study ESMO-MCBS11The score is A, bringing benefits to patients in prolonging disease-free survival, reducing the risk of recurrence, and ensuring quality of life.
Currently, Kellylong®(Ribociclib Succinate Tablets) have been approved in more than 100 countries and regions worldwide. Based on high-quality evidence from evidence-based medicine, the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines have recommended ribociclib adjuvant therapy as a Category 1 preferred treatment option for patients with HR+/HER2- early breast cancer at high risk of recurrence.12。
Novartis has been deeply engaged in the breast cancer field for decades, starting with Femara, which has been on the market for many years.®, Afinitor®`, to the latest approved Kaylilon`®Novartis is always committed to providing the best treatment options for patients at different stages, hoping to enable them to enjoy a higher quality of life while extending their lifespan by continuously developing and launching cutting-edge innovative drugs, ultimately achieving the goal of a cure.
* This product is suitable for use in combination with an aromatase inhibitor as adjuvant treatment for patients with early-stage breast cancer who are hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative, and at high risk of recurrence (see [Clinical Trials] section for selection criteria).When treating premenopausal or perimenopausal female patients or male patients with aromatase inhibitors, luteinizing hormone-releasing hormone (LHRH) agonists should be used in combination.
** NATALEE Trial ITT Population: Enrollment criteria are: 1) All lymph node-positive; 2) Lymph node-negative with T3/T4; 3) Lymph node-negative and tumor size 2-5cm with G3, G2, and Ki-67 ≥20% or high-risk gene testing.
About Kyllaron®(Ribociclib Succinate Tablets)
Kaililong®/Kisqali®(Ribociclib Succinate Tablets) is a selective cyclin-dependent kinase inhibitor. This class of drugs helps slow the progression of cancer by inhibiting two proteins, cyclin-dependent kinases 4 and 6 (CDK4/6). When these proteins are overactivated, they cause cancer cells to grow and divide rapidly. Precise targeting of CDK4/6 may play a role in ensuring that cancer cells no longer replicate uncontrollably.
Kaililong®Has been approved by regulatory agencies in more than 100 countries worldwide, including the U.S. FDA and China's National Medical Products Administration, as a treatment for breast cancer. In the United States, Kaililong®In combination with aromatase inhibitors (AI), it is indicated for the adjuvant treatment of adult patients with HR+/HER2- stage II and III early breast cancer (EBC) at high risk of recurrence, and as initial endocrine therapy for adult patients with HR+/HER2- advanced or metastatic breast cancer; Kyron®It has also been approved for use in combination with fulvestrant, suitable for the initial endocrine therapy or treatment-progressed metastatic breast cancer indications in postmenopausal women or men. In China, Kaililong®Indicated for HR+/HER2- locally advanced or metastatic breast cancer, in combination with aromatase inhibitors as the initial endocrine therapy for female patients. Also indicated as adjuvant therapy in combination with aromatase inhibitors for HR+/HER2- early breast cancer patients at high risk of recurrence. When treating premenopausal or perimenopausal female patients with endocrine therapy, a luteinizing hormone-releasing hormone (LHRH) agonist should be used concurrently.13。
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