Faslodex (fulvestrant) får positivt omnämnande av CHMP

Faslodex (fulvestrant) får positivt omnämnande av CHMP
Faslodex (fulvestrant) får positiv rekommendation för godkännande av CHMP för behandling av första linjens för HR+  lokalt avancerad bröstcancer

AstraZeneca today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending the marketing authorisation of Faslodex (fulvestrant) for the treatment of hormone receptor-positive (HR+), locally-advanced or metastatic breast cancer in postmenopausal women not previously treated with endocrine therapy, or with disease relapse on or after adjuvant anti-oestrogen therapy, or disease progression on anti-oestrogen therapy.

The CHMP recommendation is based on pivotal data from the Phase III FALCON trial, where Faslodex 500mg demonstrated superiority over anastrozole1mg in the treatment of locally-advanced or metastatic breast cancer in post-menopausal women who had not received prior hormonal-based medicine for HR+ breast cancer.

The FALCON data show that the delay in disease worsening or death (median progression-free survival, PFS) was 2.8 months longer with Faslodex than anastrozole. The median PFS was 16.6 months in the Faslodex arm compared with 13.8 months in the anastrozole arm. Aromatase inhibitors such as anastrozole are the current standard of care for the 1st-line treatment for postmenopausal women with HR+ advanced breast cancer.

Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: “Faslodex has long been an effective medicine for women with advanced breast cancer in later lines of treatment and we are pleased that the CHMP has recognised its potential as a first-line option. Faslodex is also being tested in combination with over 19 different medicines, which is testament to its well-established safety and efficacy profile with over 15 years of patient evidence since its first launch in 2002.”

The safety and tolerability profile was in line with current experience with Faslodex and anastrozole. The most-commonly reported adverse events (AEs) in the Faslodex and anastrozole arms were arthralgia (16.7% vs. 10.3%), hot flush (11.4% vs. 10.3%) and nausea (10.5% vs. 10.3%).

Faslodex is the only hormone medicine for advanced breast cancer that slows tumour growth by binding to and degrading the oestrogen receptor – a key driver of breast cancer progression in some women. It is widely approved for the treatment of HR+ advanced breast cancer in postmenopausal women with disease progression following anti-oestrogen medicine.

The CHMP’s positive opinion will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union (EU). The final decision will be applicable to all 28 EU member countries plus Iceland, Norway and Liechtenstein.