Paige Breast Lymph Node designed to enhance diagnostic accuracy and confidence detecting breast cancer metastases of any size in lymph node tissue
Lynparza is approved in the US, EU, Japan and several other countries for the treatment of patients with gBRCAm, HER2-negative, metastatic breast cancer previously treated with chemotherapy based on results from the OlympiAD Phase III trial
Application based on DESTINY-Breast03 results showing Daiichi Sankyo and AstraZeneca’s trastuzumab deruxtecan reduced risk of disease progression or death by 72% versus trastuzumab emtansine (T-DM1)
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In Japan, breast cancer is the most common cancer in women, with approximately 92,000 cases of breast cancer diagnosed in 2020
With the MONALEESA-2 final analysis, only Kisqali has reported statistically significant overall survival (OS) benefit with an aromatase inhibitor for postmenopausal women with HR+/HER2- advanced breast cancer in the first-line (1L) setting
The drug is approved for the treatment in metastatic colorectal carcinoma, metastatic breast cancer and ovarian, cervical and renal cancer
The company will review FDA's response and decide on appropriate next steps soon.
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