LONDON (dpa-AFX) - AstraZeneca PLC (AZN.L, AZN) announced results from a pre-specified subgroup analysis of the positive Phase III FALCON trial suggesting that treatment effects in terms of progression-free survival were largely consistent across the subgroups analyzed with some possible exceptions, including patients with non-visceral disease. AstraZeneca is pursuing a label extension with US regulatory authorities to include the FALCON results in the FASLODEX label.
The FALCON trial assessed FASLODEX (fulvestrant) 500 mg compared to ARIMIDEX (anastrozole) 1 mg in the 1st line endocrine treatment of postmenopausal women who were initially diagnosed with locally-advanced or metastatic breast cancer who had not had prior hormonal treatment for hormone receptor positive (HR+) breast cancer. The FALCON trial met its primary endpoint and revealed a median PFS of 16.6 months in the FASLODEX arm compared to 13.8 months median PFS in the ARIMIDEX arm. The safety and tolerability profile was in line with current experience with FASLODEX and ARIMIDEX.
Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: 'The findings from this subgroup analysis build upon the existing body of clinical evidence for FASLODEX. AstraZeneca is committed to investigating the potential of FASLODEX in the 1st line setting for women with advanced breast cancer alongside the development of new targeted medicines and immunotherapies for women with all types of early and advanced breast cancer.'
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