Faslodex

  • Email
  • Help

Questions & Answers

On 12 October 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 the medicinal product Faslodex. The marketing authorisation holder for this medicinal product is AstraZeneca UK Ltd.

The CHMP adopted an extension to the existing new indication as follows:1

“Faslodex is indicated:

  • as monotherapy 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 progression on antiestrogen therapy.
  • in combination with palbociclib for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in women who have received prior endocrine therapy (see section 5.1).

In pre- or perimenopausal women, the combination treatment with palbociclib should be combined with a luteinizing hormone releasing hormone (LHRH) agonist.”

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.


1 New text in bold

Name Language First published Last updated
CHMP post-authorisation summary of positive opinion for Faslodex (English only) 2017-10-13  

Key facts

Product details for Faslodex
NameFaslodex
INN or common name

fulvestrant

Therapeutic area Breast Neoplasms
Active substance

fulvestrant

Date opinion adopted12/10/2017
Company name

AstraZeneca UK Ltd

StatusPositive
Application typePost authorisation