Questions and Answers on Femara and Associated Names (letrozole, 2.5 mg tablets)
15 March 2012
EMA/180824/2012
EMEA/H/A-30/1264
Outcome of a procedure under Article 30 of Directive
2001/83/EC
On 15 March 2012, the European Medicines Agency completed a review
of Femara. The Agency’s
Committee for Medicinal Products for Human Use (CHMP) concluded
that there is a need to harmonise
the prescribing information for Femara in the European Union
(EU).
What is Femara?
Femara is a medicine that contains the active substance letrozole.
It is used as hormonal treatment in
postmenopausal women with breast cancer.
The active substance in Femara, letrozole, is an ‘aromatase
inhibitor’. This means that it works by
blocking the action of an enzyme called ‘aromatase’,
which is involved in the production of the
hormone oestrogen. In some types of breast cancer (hormone receptor
positive or hormone-dependent
types), oestrogen is known to stimulate the growth of the cancer
cells. By blocking the activity of
aromatase and thereby reducing the amount of oestrogen produced,
the medicine slows or stops the
growth and spread of the cancer.
Femara is used in postmenopausal women because aromatase is
involved in producing most of the
oestrogen in this population.
Femara is marketed in all EU Member States and is also available
under other trade names: Femar,
Fémara, and Loxifan.
The company that markets these medicines is Novartis.
Why was Femara reviewed?
Femara is authorised in the EU via national procedures. This has
led to divergences across Member
States in the way the medicine can be used, as seen in the
differences in the summaries of product
characteristics (SmPCs), labelling and package leaflets in the
countries where the medicine is
marketed.
Questions and answers on Femara and associated names (letrozole,
2.5 mg tablets)
EMA/180824/2012 Page 2/2
Femara was identified as needing harmonisation by the Co-ordination
Group on the Mutual and
Decentralised Procedures – Human (CMD(h)).
On 31 August, the European Commission referred the matter to the
CHMP in order to harmonise the
marketing authorisations for Femara in the EU.
What are the conclusions of the CHMP?
The CHMP, in light of the data submitted and the scientific
discussion within the Committee, was of the
opinion that the SmPCs, labelling and package leaflets should be
harmonised across the EU.
The main areas harmonised include:
4.1 Therapeutic indications
After reviewing the available data supporting the medicine’s
use, the CHMP agreed that Femara should
be used in postmenopausal women for the following:
? Adjuvant (post-surgery) treatment of
hormone receptor positive invasive early breast cancer.
? Extended adjuvant treatment of
hormone-dependent invasive breast cancer in women who have
received prior standard adjuvant tamoxifen therapy for five
years.
? First-line treatment for
hormone-dependent advanced breast cancer.
? Advanced breast cancer after relapse or
disease progression, in women with natural or artificially
induced postmenopausal endocrine status, who have previously been
treated with anti-oestrogens.
? Neo-adjuvant (pre-surgery) treatment of
hormone receptor positive, HER-2 negative breast cancer
where chemotherapy is not suitable and immediate surgery not
indicated.
4.2 Posology and method of administration
Having harmonised the indications, the CHMP also harmonised
recommendations on the doses,
duration of treatment and use of Femara in patients with reduced
kidney or liver function.
4.3 Contra-indications
In harmonising the contraindications, the CHMP decided against
including two contraindications that
were in the SmPCs of some EU countries: liver impairment and
pre-operative use in patients whose
receptor status is negative or unknown. The CHMP was of the view
that it was more appropriate to
include relevant warnings in section 4.4.
Other changes
The CHMP also harmonised other sections of the SmPC including
sections 4.6 (pregnancy and
lactation) and 4.8 (side effects).
The amended information to doctors and patients is available
here.
A European Commission decision on this opinion will be issued in
due course.
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© European Medicines Agency, 2012. Reproduction is authorised
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Posted: March 2012
