Date: 2017-07-26
Type of information: Granting of a Market Authorisation in the EU
Product name: Faslodex®
Compound: fulvestrant
Therapeutic area: Cancer - Oncology
Action mechanism:
- oestrogen receptor antagonist. Faslodex® (fulvestrant) is an estrogen receptor antagonist indicated for the treatment of postmenopausal women with ER+, locally-advanced or metastatic breast cancer for disease relapse on or after adjuvant anti-oestrogen therapy, or disease progression on therapy with an anti-oestrogen. In the US, Faslodex® 500mg is also approved, in combination with palbociclib, for the treatment of US women with HR+, human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer (MBC), whose cancer has progressed after endocrine therapy. Faslodex 500mg represents a hormonal therapy approach that helps to slow tumour growth by blocking and degrading the oestrogen receptor.
- Faslodex® was first approved in 2002 and is currently being tested in combination with over 19 different medicines for the treatment of women with advanced HR+ breast cancer.
Company: AstraZeneca (UK)
Disease: estrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women
Latest news:
- • On July 26, 2017, AstraZeneca announced that the European Commission (EC) has approved Faslodex® (fulvestrant) for the treatment of oestrogen-receptor positive, locally-advanced or metastatic breast cancer in postmenopausal women not previously treated with endocrine therapy.
- The EU approval is based on pivotal data from the Phase III FALCON trial, which demonstrated the superiority of Faslodex 500mg over anastrozole 1mg as a first-line treatment for postmenopausal women with locally-advanced or HR+ metastatic breast cancer who had not received prior hormone-based therapy. Median progression-free survival (PFS) was significantly longer with Faslodex® than with the aromatase inhibitor, anastrozole - 16.6 months versus 13.8 months (HR: 0.797; 95% CI: 0.637-0.999; p=0.0486).
- The safety and tolerability profiles for Faslodex® and anastrozole reported in the FALCON trial were in line with current experience. 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%). The FALCON trial was designed on the basis of positive results from the Phase II FIRST trial, which demonstrated a median overall survival nearly six months longer with Faslodex compared to anastrozole.
- • On June 22, 2017, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion
recommending a change to the terms of the marketing authorisation for Faslodex®. The new indication is as follows
:“Faslodex is indicated for the treatment of estrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women:
• not previously treated with endocrine therapy, or
• with disease relapse on or after adjuvant antiestrogen therapy, or disease progressionon antiestrogen therapy.”.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization:
UE authorization: 2017-07-26
Favourable opinion UE: 2017-06-22
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE:
OTC status:
Other news:
Is general: Yes
