AstraZeneca (AZ; NASDAQ: AZN), headquartered in the UK, has registered with Japan’s Ministry of Health, Labour, and Welfare (MHLW) its first-in-class AKT inhibitor, Truqap (capivasertib), in combination with endocrine therapy Faslodex (fulvestrant). This combination therapy is intended for the treatment of unresectable or recurrent PIK3CA-, AKT1-, or PTEN-altered HR-positive, HER2-negative breast cancer in adults who have previously undergone endocrine therapy. The registration follows a similar approval in the US market last year.
The decision was based on a priority review of Phase III data, which showed that the combination therapy increased median progression-free survival (PFS) to 7.3 months from 3.1 months with fulvestrant alone. The therapy also displayed a safety profile similar to that observed in previous studies.
AstraZeneca has filed the medicine for review in markets such as China and the European Union (EU), and under the simultaneous filing platform Project Orbis in Australia, Brazil, Canada, Israel, Singapore, Switzerland, and the UK.- Flcube.com
