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AstraZeneca Fulvestrant And CDK4/6 Inhibitor Combination Therapy Approved in China

Recently, AstraZeneca China announced that the National Medical Products Administration (NMPA) of China has officially approved the combination therapy of fulvestrant injection and CDK4/6 inhibitor Abexili, which is suitable for hormone receptor (HR) positive, human epidermal growth Factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer is used for patients who have experienced disease progression after receiving endocrine therapy. It is reported that this is the first combination indication approved by Fulvestrant in China, bringing new treatment options for patients with advanced breast cancer.


Fulvestrant injection is an estrogen receptor antagonist, which can be combined to block and degrade estrogen receptors. It can be used for relapse after or during the course of anti-estrogen adjuvant therapy, or in anti-estrogen therapy. Moderately advanced postmenopausal (including natural and artificial menopause) estrogen receptor-positive locally advanced or metastatic breast cancer. Abbexilide is an inhibitor of cyclin-dependent kinase (CDK) 4 and 6, which is activated by binding to cyclin D.


Breast cancer is one of the most common malignant tumors in women worldwide. Public data shows that in the new cases of breast cancer each year, about 3% to 10% of patients have distant metastases at the time of diagnosis. The advanced 5-year survival rate of breast cancer patients is only about 20%, and the overall median survival time is only 2 to 3 years. Among the subtypes of advanced breast cancer, HR-positive and HER2-negative accounted for about 60%. As an incurable heterogeneous malignant tumor, HR-positive advanced breast cancer seriously affects the life and health of women, and patients urgently need new treatment options to improve the prognosis.