Differentiate the Brand. The market is very competitive. Licensed. Indications. Early BC. –. Early BC. –. st. nd. Women at. Noninvasive. 1. Line. 2. Line. Primary. Extended. increased. cancer. advanced. advanced. Adjuvant. Adjuvant. risk*. (DCIS). BC. BC. Data &.
The major focus today will be differentiation from AIs focusing on ARIMIDEX vs letrozole.
Initial adjuvant therapy
Efficacy vs tamoxifen
Full risk:benefit profile
Switching from tamoxifen
Efficacy vs tamoxifen
Extended adjuvant setting
Efficacy vs placebo
Key Issue: Differentiation vs letrozole
Establish Arimidex as the standard of care for early BC
Compared with tamoxifen
Cardiovascular events (grade 3-5)
There are clear differences in the safety profiles of anastrozole and letrozole in the primary adjuvant setting
?=not reported, NS=non-significant
In high risk patients
GIVE 5 YEARS PRIMARY ADJUVANT THERAPY WITH LETROZOLE
Lower risk – trade lower initial efficacy for long term duration
as low risk patients are less likely to relapse early
GIVE 5 YEARS TMX FOLLOWED BY 5 YEARS LETROZOLE
Letrozole is the only treatment shown to significantly reduce risk of recurrence both as initial therapy post-surgery and also following standard tamoxifen
Letrozole has the broadest and most impressive efficacy dataset across the breast cancer continuumLetrozole Sales Story Flow
The BC diagnosis is a period of great uncertainty for a woman
She wants to be reassured that she has the best possible chance that the BC will not come back
Tamoxifen is now no longer the best you can offer
It is no longer optimal adjuvant therapy
With ‘Arimidex’ you can be confident you are doing the best that you can to reduce the risk of her BC coming back or of her dying of the disease
You can reassure her that you are giving her the best that you have to offer
We know from the Oxford Overview that the risk of recurrence is
greatest in the first 5 years post diagnosis – irrespective of nodal
status, receptor status or tumour size
So it is important to use the most effective treatment from the outset
She will have a lower risk of breast cancer recurrence, a lower risk of
contralateralbreast cancer and a lower risk of life threatening
distant recurrence whether she starts or switches to ‘Arimidex’
The other thing women worry about when making treatment decisions is
‘how will this treatment affect me? What are the side effects?
Arimidex has a significantly better safety profile than tamoxifen with
a lower risk of serious adverse events such as thrombosis, stroke and
There are marked differences in the safety of AIs when used in the
adjuvant setting and the AIs can not be used interchangeably.
The full benefit/risk profile of ‘Arimidex’ is known
Only ‘Arimidex’ has established efficacy and safety with more than 5 years
long term follow up data
You can give her more certainty at an uncertain time.
‘Arimidex’ provides her the best possible chance to beat breast cancer and more
assurance about the safety of her treatment.
Isn’t this the best you can offer her?
This is why ‘Arimidex’ is now the best
endocrine treatment option and the new
standard of care in early breast cancer
Based on the evidence above Arimidex remains the best
endocrine treatment option and the best standard of care for
postmenopausal women with hormone-sensitive early breast cancer
Mixture of tam / Arimidex/AI
Arimidex/AI is my standard in EBC
CORE STORY FLOW
Selective inhibition of aromatase is essential to avoid toxicity due to disturbance of complex pathways of steroid synthesis
The long-term clinical differences between Arimidex and letrozole are still to be determined but has the poetntial to become clinically relevant in the long-term 5 year adjuvant treatment of early breast cancer.
Change in lipid profiles are major risk factors for CHD, MI and stroke
Data from the advanced setting suggest that letrozole and exemestane may have the potential to produce adverse effects on lipid profiles when administered long term.
Side effects of androgenic activity distressing and potentially dangerous
Arimidex and letrozole exhibit no adverse androngenic, oestrogenic or progestogenic activity
Arimidex : Impact on bone is known and manageable
Arimidex is the only AI with long-term data quantifying its impact on bone in women with early breast cancer.
Is CV toxicity a class effect ? Novartis say it is …..
Differences between AIs result in differences in safety profiles when given long-term. This seems to be evident when considering the effect of the AIs on cardiovascular events.
Only Arimidex has a fully established long-term risk-benefit profile with data covering the full recommended 5-year treatment period
A marketing drivendata collection programme in a real world situation based around physicians prescribing a licensed drug to demonstrate product benefitsand to gain physician buy-in
July / Aug
Aug / November
or brand new ideas