AstraZeneca's Truqap Plus Faslodex Recommended For EU Approval By CHMP For Advanced Breast Cancer

(RTTNews) - AstraZeneca's Truqap (capivasertib) in combination with Faslodex (fulvestrant) has been recommended for approval in the European Union (EU) for the treatment of adult patients with estrogen receptor (ER)-positive, HER2-negative locally advanced or metastatic breast cancer with one or more PIK3CA, AKT1, or PTEN-alterations following recurrence or progression on or after an endocrine-based regimen.

The recommendation by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) was based on the results of the CAPItello-291 trial, which showed that the Truqap combination reduced the risk of disease progression or death by 50% versus Faslodex standard of care in a biomarker-altered population.

AstraZeneca noted that regulatory applications are currently under review in China and several other countries, and similar indications for Truqap in combination with Faslodex are already approved in Japan, the US and several other countries based on results from the CAPItello-291 trial.

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