UK-based pharmaceutical company AstraZeneca (AZ; NASDAQ: AZN) announced last week that it has received regulatory approval from the US Food and Drug Administration (FDA) for its first-in-class AKT inhibitor, Truqap (capivasertib), in combination with fulvestrant. This treatment is indicated for HR-positive, HER2-negative locally advanced or metastatic recurrent or refractory breast cancer with one or more biomarker alterations. The FDA’s 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, while maintaining a safety profile consistent with previous observations.
Global Submissions for Truqap Underway
AstraZeneca has also submitted Truqap for regulatory review in major markets such as China, the European Union (EU), and Japan. Additionally, the company has filed the medicine under the simultaneous filing platform Project Orbis in Australia, Brazil, Canada, Israel, Singapore, Switzerland, and the UK, demonstrating its commitment to making this treatment available to patients worldwide.- Flcube.com
