On May 14, Novartis China announced that its blockbuster breast cancer treatment product Kelilon (Rippocili succinate tablets) has been approved by the State Food and Drug Administration for new indications, suitable for use with aromatase inhibitors as an adjuvant treatment for early-stage breast cancer patients who are positive for hormone receptor (HR) and negative for human epidermal growth factor receptor 2 (HER2) at a high risk of recurrence.

As the world's first and currently the only CDK4/6 inhibitor approved for a wide range of stage II-III HR+/HER2-breast cancer adjuvant therapy (including some people without lymph node metastasis [N0]), Kelilon will help more breast cancer patients in China reduce the risk of early recurrence and bring hope of cure. This is another new indication that Kellylon has been approved in China in addition to the first-line treatment of advanced breast cancer.

Li Yao, President and Managing Director of Novartis China, said: "Breast cancer is the 'number one' that threatens the health of women around the world, and is also one of the areas of disease that Novartis focuses on. The approval of the indication for adjuvant treatment of early breast cancer in Kellyron has further expanded the applicable population based on its first-line treatment of advanced breast cancer, covering the treatment of early and advanced breast cancer patients throughout the process, which is expected to help more breast cancer patients achieve a leap from 'extended survival' to 'cooling possible'. In the future, we will continue to uphold the belief of 'committing to China' and help Chinese patients prolong their lives and improve their quality of life through innovative therapies."

The long-term risk of early breast cancer recurrence is urgently needed

HR+/HER2-Although early breast cancer can be cured, up to one-third of patients still relapse and metastasis even after receiving traditional auxiliary endocrine therapy, progressing to an incurable disease. The risk of breast cancer recurrence will not completely disappear over time, and early HR+ breast cancer patients usher in a peak in recurrence three years after surgery. Studies have shown that various factors such as lymph node metastasis status, tumor size, histological grading, Ki-67 expression (referring to the proportion of Ki-67 positive cells in tumor tissues), multigene detection data, etc. are related to the increased risk of recurrence in HR+/HER2-early breast cancer.

Real-world research data show that for patients without lymph node metastasis and those without lymph node metastasis who have lymph node metastasis and high-risk risk factors, the risk of recurrence is three times that of other early patients, which fully demonstrates the unmet clinical needs of this group of people. Based on this, the enrolled population selected for the Riposili critical phase III NATALEE study meets clinical needs. For these patients, regardless of whether there is lymph node metastasis, they should communicate fully with the doctor, formulate personalized treatment and follow-up plans, and strive to achieve cure goals.

Riposili's early breast cancer indications are approved to help more patients reduce recurrence and move towards cure

The application of CDK4/6 inhibitors in adjuvant therapy for HR+/HER2-early breast cancer reduces the risk of recurrence and metastasis in early patients. Ripoli’s approval this time is based on NATALEE research. Compared with adjuvant endocrine therapy alone, the risk of recurrence and distant metastasis of 4 years decreased by 28.5%, and consistent benefits were observed in all subgroups including no lymph node metastasis or stage II, further demonstrating the long-lasting and wide-ranging benefits of adjuvant intensive therapy in patients with early stage breast cancer. At the same time, the risk of death in Ripoli assisted intensive treatment continues to be reduced compared with the adjuvant endocrine therapy alone. In terms of safety, the adverse reaction spectrum of Ripoli is consistent with previous studies, and no new safety signals appear, mostly of level 1-2 and unsensible toxicity. In terms of quality of life, the intensive treatment group of Ripoli is consistent with the control group in terms of quality of life scores, and the 4-year follow-up data further demonstrated that Ripoli is good long-term tolerant. The NATALEE study ESMO-MCBS score is A, which benefits patients in prolonging disease-free survival, reducing recurrence risk and ensuring quality of life.

Kisqali (Rippocili succinate tablets) is a selective cell cycle-dependent protein kinase inhibitor that helps slow cancer progression by inhibiting cell cycle-dependent protein kinases 4 and 6 (CDK4/6). When these proteins are overactivated, cancer cells can grow and divide rapidly. Precise targeting CDK4/6 may play a role in ensuring that cancer cells no longer replicate uncontrollably.

At present, Kelilon (ripolicili succinate tablets) has been approved in more than 100 countries and regions around the world. Based on high-quality evidence-based medical evidence, the National Comprehensive Cancer Network Clinical Practice Guidelines has adopted Ripoli assisted treatment regimen as a Class 1 priority recommended treatment option for patients with high risk of recurrence in early breast cancer.

[Editor in charge: Wang Yuqi]