AstraZeneca‘s AKT Inhibitor Capivasertib Gains Domestic Approval, Redefining Breast Cancer Treatment Paradigm
Time:2025-04-27
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On April 18, 2025, China‘s National Medical Products Administration (NMPA) granted approval to AstraZeneca‘s Class 1 innovative drug Capivasertib tablets (TRUQAP®), marking the first-ever global approval of an AKT inhibitor. This breakthrough therapy, administered in combination with fulvestrant, addresses a critical unmet need in treating hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer patients with PIK3CA/AKT1/PTEN alterations who have experienced disease progression following at least one prior endocrine therapy in metastatic settings, or recurrence within 12 months of completing adjuvant therapy.
Breast cancer, a malignant tumor originating from mammary epithelial tissues, manifests through abnormal cellular proliferation, local tissue invasion, and metastasis via lymphatic or hematogenous systems to distant organs (e.g., lungs, bones, liver). In China, it ranks as the second most prevalent and fifth leading cause of cancer-related mortality among women. Notably, HR-positive/HER2-negative subtypes account for over 70% of breast cancer cases.
Current first-line standard therapy for HR+/HER2- breast cancer involves CDK4/6 inhibitors combined with endocrine treatment. However, approximately 50% of patients develop resistance. Capivasertib stands as the only PAM pathway inhibitor primarily indicated for CDK4/6 inhibitor-pretreated populations. Representative CDK4/6 inhibitors include abemaciclib and palbociclib, though manufacturing-related impurities in these agents may compromise therapeutic safety and efficacy. The domestic launch of capivasertib propels targeted therapy advancements while necessitating more rigorous standards in multiple domains: exploration of CDK4/6 inhibitor resistance mechanisms, impurity source tracing, companion diagnostic standardization, and enhanced impurity profiling/purification processes for drugs like abemaciclib.
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