Novartis Submits New Drug Application in China for Ribociclib (Lipexili) for HR+/HER2- Breast Cancer

Text | Pharma Insight

On October 22, the latest public notice from the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) indicated that Novartis has submitted a new drug application (NDA) in China for ribociclib succinate tablets, which has been accepted for review. Based on publicly available information, the product is presumed to be Novartis's CDK4/6 inhibitor ribociclib, which has previously been approved for marketing in dozens of countries and regions, including the United States and the European Union, for multiple breast cancer indications.

Screenshot source: CDE official website

Ribociclib (Kisqali, LEE011) is a selective cyclin-dependent kinase inhibitor that helps slow cancer progression by inhibiting the two proteins cyclin-dependent kinase 4 and 6 (CDK4/6). When these proteins are overactivated, they can accelerate the growth and division of cancer cells. Ribociclib inhibits CDK4/6 with higher specificity, preventing the uncontrolled continued proliferation of cancer cells.

According to publicly available information, ribociclib was initially approved by the FDA in combination with an aromatase inhibitor as initial endocrine therapy for postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer. Subsequently, it was also approved in combination with an aromatase inhibitor as initial endocrine therapy for premenopausal, perimenopausal, or postmenopausal women, and in combination with fulvestrant as first-line or second-line therapy for postmenopausal women.

At the 2021 European Society for Medical Oncology Congress (ESMO 2021), Novartis announced the final results of ribociclib in combination with letrozole for the treatment of postmenopausal patients with HR-positive, HER2-negative advanced or metastatic breast cancer. In this Phase 3 clinical trial, the median overall survival (OS) for patients treated with the ribociclib and letrozole combination was 63.9 months, significantly superior to 51.4 months in the control group. Additionally, compared with letrozole monotherapy, the ribociclib/letrozole combination delayed the time to initiation of chemotherapy by 12 months.

Results from another phase 3 study, MONALEESA-7, conducted in premenopausal women with HR-positive/HER2-negative metastatic breast cancer, showed that at a median follow-up of 53.5 months, the ribociclib plus endocrine therapy group continued to demonstrate an OS benefit compared with the placebo plus endocrine therapy group, with median OS of 58.7 months and 48.0 months, respectively.

According to the China Drug Clinical Trial Registration and Information Public Disclosure Platform, two clinical trials of ribociclib have been registered and conducted in China, namely: 1) A Phase II randomized, double-blind study of ribociclib or placebo in combination with endocrine therapy in Chinese premenopausal and postmenopausal women with hormone receptor-positive, HER2-negative advanced breast cancer; 2) A Phase III study evaluating the efficacy and safety of ribociclib in combination with endocrine therapy as adjuvant therapy in patients with hormone receptor-positive, HER2-negative early breast cancer.

Breast cancer is the most common type of cancer among women worldwide. According to the latest global cancer burden data for 2020 released by the International Agency for Research on Cancer (IARC) of the World Health Organization, there were 2.26 million new cases of breast cancer globally in 2020, surpassing lung cancer for the first time to become the most commonly diagnosed cancer worldwide. For female patients with hormone receptor-positive breast cancer, endocrine therapy is the standard of care; however, patients are prone to developing resistance following treatment, leaving an unmet treatment need.

References:

[1] Official website of the Center for Drug Evaluation, National Medical Products Administration (China). Retrieved Oct 22, 2021, from https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026

[2] Novartis presents new Kisqali® data showing longestmedian overall survival ever reported in HR+/HER2- advanced breast cancer.Retrieved September 19, 2021, from https://www.novartis.com/news/media-releases/novartis-presents-new-kisqali-data-showing-longest-median-overall-survival-ever-reported-hrher2-advanced-breast-cancer

[3] Novartis Kisqali® demonstrates nearly five years median overall survival in metastatic breast cancer.Retrieved Dec 09, 2020, from https://www.novartis.com/news/media-releases/novartis-kisqali-demonstrates-nearly-five-years-median-overall-survival-metastatic-breast-cancer

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