Elacestrant, if approved, would be the first oral selective estrogen receptor degrader (SERD) to be available for patients suffering from second-line (2L) and third-line (3L) ER+/HER2- advanced or metastatic breast cancer in the European Union
The decision is based on the outcome of a prespecified interim analysis of the Phase 3 AMEERA-5 trial
Results consistent with previous trials, reinforcing benefit of Daiichi Sankyo and AstraZeneca’s ENHERTU in previously treated patients
First and only PARP inhibitor to improve invasive disease-free survival, the primary endpoint, and overall survival, a key secondary endpoint, in these patients
First and only PARP inhibitor to improve invasive disease-free survival in patients
Intended for potential treatment of ER+/HER2- advanced or metastatic breast cancer patients
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
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