AstraZeneca breast cancer drug Faslodex is approved by the European Union for first-line treatment of advanced breast cancer

British pharmaceutical giant AstraZeneca's breast cancer drug Faslodex (fulvestrant, fulvestrant) has recently received great news in EU regulation. The European Commission (EC) has approved Faslodex for first-line treatment of postmenopausal women with estrogen receptor-positive (ER+) locally advanced or metastatic breast cancer who have not previously received endocrine therapy.

The approval is based on positive data from FALCON, a phase III clinical trial of breast cancer. The study was a randomized, double-blind, multicenter study of Faslodex 500 mg injection in postmenopausal women with hormone receptor-positive (HR+) locally advanced or metastatic breast cancer who had not received any hormonal therapy. Compared with AstraZeneca's breast cancer drug aromatase inhibitor Arimidex 1mg tablets (brand name: Ruining, common name: anastrozole, anastrozole) for the efficacy and safety of first-line treatment.

The study data confirmed that Faslodex was significantly superior to Arimidex in first-line treatment: the median progression-free survival (PFS) was significantly prolonged in the Faslodex 500 mg treatment group compared with the Arimidex 1 mg treatment group (16.6 months vs 13.8 months). , HR=0.797, 95% CI: 0.637-0.999, p=0.0486), reached the primary endpoint of the study. Currently, in the first-line treatment of postmenopausal women with HR+ advanced breast cancer, aromatase inhibitors (such as Arimidex) are standard care drugs. Faslodex 500 mg significantly prolongs progression-free survival compared to Arimidex 1 mg, indicating that the drug will provide an earlier treatment option for postmenopausal women with locally advanced or metastatic HR+ breast cancer.

In this study, the safety and tolerability of Faslodex and Arimidex were consistent with the currently known treatment experience for each drug. The most common adverse events (AE) for Faslodex and Arimidex included arm and joint pain (16.7% vs. 10.3%), hot flashes (11.4% vs. 10.3%), and nausea (10.5% vs. 10.3%).

阿斯利康乳腺癌药物Faslodex获欧盟批准用于晚期乳腺癌一线治疗

Jamie Freedman, head of AstraZeneca's oncology business unit and executive vice president, said the EU's first-line treatment approval demonstrates the scientific strength of Faslodex's more than 15 years of clinical experience. Now, postmenopausal women with HR+ advanced breast cancer can benefit from Faslodex treatment in the early stages of the disease. The company will continue to explore the full potential of this important drug, such as monotherapy and combination with other drugs.

The study's lead researcher, Dr. Matthew Ellis, director of the Bayer School of Medicine's Liszt and Hugh-Smith Breast Center, said data from the FALCON study showed that Faslodex was used in first-line treatment to significantly increase disease risk or death risk compared with standard care. A 20% reduction is a major advancement in the clinical treatment of postmenopausal women with HR+ advanced breast cancer who have not received treatment. Research evidence suggests that early application of Faslodex in these patients will significantly delay the progression of the disease.

Faslodex is the only hormonal drug used in the treatment of advanced breast cancer, which delays tumor growth by binding to and degrading estrogen receptors. In some patients, estrogen receptors are a key driver of breast cancer progression. Currently, Faslodex has been widely approved for the treatment of post-menopausal women with HR+advanced breast cancer after anti-estrogen therapy. Faslodex was first approved for marketing in 2002, and AstraZeneca is currently testing more than 19 Faslodex combination regimens for the therapeutic potential of HR+ advanced breast cancer patients.

Breast cancer is the number one common malignancy in the female population, and advanced breast cancer (ABC) refers to stage III and IV breast cancer. Stage III is also known as local advanced stage, and stage IV refers to metastatic breast cancer. This is also the most advanced stage, and cancer cells have spread from the breast to other parts of the body. At present, there is no medicine to cure advanced breast cancer. In clinical practice, the treatment goal of advanced breast cancer is to delay the deterioration or death of the disease.

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