LONDON (dpa-AFX) - 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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