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Source: Guanlan Pharmaceutical
On the evening of August 27th, AstraZeneca China announced that the National Medical Products Administration (NMPA) of China has officially approved the combined treatment of fulvestrant injection (fulvestrant) and the 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
Fulvestrant injection is an estrogen receptor antagonist, which can be combined to block and degrade estrogen receptors.
The research related to this approval mainly includes:
The MONARCH 2 study is a randomized, double-blind, placebo-controlled phase 3 study in women with HR-positive, HER2-negative, locally advanced or metastatic breast cancer
·Themedian PFS of the abecili combined with fulvex group was significantly prolonged, with a median PFS of 16.
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·ITT population overall survival (OS) analysis showed that patients who received combination therapy had a statistically significant improvement over placebo combined with fulvestrant
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·The most common adverse reactions (≥20%) reported in the fulvestrant combined with abesiride group were diarrhea, fatigue, neutropenia, nausea, infection, abdominal pain, anemia, leukopenia, decreased appetite, vomiting and Headache
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Another MONARCH plus study, a randomized, double-blind, placebo-controlled phase 3 study, evaluated in the postmenopausal population of HR-positive, HER2-negative, locally recurring or metastatic breast cancer, mainly Chinese patients The effectiveness and safety of abexiride combined with aromatase inhibitors and abexiride combined with fulvestrant
The results of the study showed that the median PFS of the abecilide combined with fulvex group was significantly prolonged, with a median PFS of 11.
Breast cancer is one of the most common malignant tumors in women worldwide
