AstraZeneca's (AZN) Truqap Gets EU Nod for Breast Cancer [Yahoo! Finance]
AstraZeneca PLC - American Depositary Shares (AZN)
Last astrazeneca plc - american depositary shares earnings: 2/5 04:00 pm
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Source: Yahoo! Finance
The EC has approved Truqap in combination with Faslodex for treating adult patients with estrogen receptor (ER)-positive, HER2-negative locally advanced or metastatic breast cancer whose tumors have qualifying alterations in the PIK3CA, AKT1 or PTEN genes following recurrence or progression on or after an endocrine-based regimen. Following the nod in the EU, Truqap became the first and only AKT inhibitor to be approved for treating breast cancer patients with the PIK3CA, AKT1 or PTEN biomarker alterations. The EC's approval was based on data from the phase III CAPItello-291 study. Data from the study showed that treatment with Truqap plus Faslodex reduced the risk of disease progression or death by 50% compared with Faslodex in combination with placebo in the given patient population. The approval in Europe was expected as the Committee for Medicinal Products for Human Use of the European Medicines Agency recommended the approval of Truqap in combination with Faslodex for treat
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