Two Japanese approvals for AstraZeneca

UK pharma major AstraZeneca’s (LSE: AZN) shares edged up 1% to 10,550 pence in early trading, as the company announced receipt of two approvals from the Japanese medicines regulator.

First, it said that Truqap (capivasertib) in combination with Faslodex (fulvestrant) has been approved in Japan for the treatment of adult patients with unresectable or recurrent PIK3CA, AKT1, or PTEN-altered hormone receptor (HR)-positive, HER2-negative breast cancer following progression after treatment with endocrine therapy.

The approval by the Japanese Ministry of Health, Labor, and Welfare (MHLW) was based on the results from the  CAPItello-291 Phase III trial published in  The New England Journal of Medicine .In the trial, the combination of the two drugs reduced the risk of disease progression or death by 50% versus Faslodex alone in patients with tumors harboring PI3K/AKT pathway biomarker alterations (based on hazard ratio of 0.50, 95% confidence interval 0.38-0.65; p=<0.001; median progression-free survival (PFS) 7.3 versus 3.1 months).