Where Roche hits wall, AstraZeneca finds path to speedy FDA review

12 June 2023
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The US regulator is to review a submission from British drugmaker AstraZeneca (LSE: AZN) for capivasertib, in combination with Faslodex (fulvestrant), under the Priority Review scheme.

The novel AKT inhibitor, which is  backed by positive results from the Phase III CAPItello-291 study, has the potential to become a new treatment for people with breast cancer who have progressed despite existing options, or who have become resistant to them.

When added to Faslodex, capivasertib demonstrated a 40% reduction in the risk of disease progression or death in the overall trial population.

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