The US FDA approved the ADC drug gosatumumab (Trodelvy) for the treatment of patients with hormone receptor-positive, HER2-negative breast cancer. In the trial, the drug significantly extended the overall survival of patients and reduced the risk of death by 21%.
"Breast cancer"
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In recommendations released on 2 February 2023, the National Comprehensive Cancer Network (NCCN) recommends that doctors consider neratinib for patients with HER2-negative metastatic breast cancer, regardless of their estrogen receptor status.
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St. Marianna's Medical University Hospital is one of the top hospitals in Japan, specializing in breast surgery and other related diseases.
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DZD1516 is a reversible, selective HER2-targeting agent with full blood-brain barrier penetration. It has demonstrated good therapeutic response in phase I studies in patients with metastatic HER2-positive breast cancer, including breast cancer patients with central nervous system metastases.
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Apparatus
New Drug Expected For Patients With Low HER2 Expression, FDA Grants Priority Review Status To Enhertu
The FDA granted priority review status to Enhertu (DS-8201) for the treatment of patients with HR-positive, low HER2-expressing breast cancer, and Enhertu has enabled these patients to remain disease-free for an average of 10.1 months, with an average overall survival time of nearly two years. A decision on approval is expected to be made in the fourth quarter of this year.