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FEMARA (letrozole), aromatase inhibitor
ONCOLOGY - New indication
Opinions on drugs -
Posted on
Dec 22 2015
Reason for request
Extension of Inclusion
No clinical benefit over standard care demonstrated in the neoadjuvant treatment of HER-2 negative breast cancer
- FEMARA now has Marketing Authorisation in the neoadjuvant treatment of postmenopausal women with hormone receptor positive, HER-2 negative breast cancer where chemotherapy is not suitable and immediate surgery is not indicated.
- It has demonstrated an improvement in overall response and an increase in the percentage of patients who can undergo conservative surgery in comparison with tamoxifen, but the population studied in the clinical trial differs from the Marketing Authorisation population; the transferability of the results is therefore uncertain.
Clinical Benefit
| Substantial |
- |
Clinical Added Value
| no clinical added value |
- |
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