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PERJETA (pertuzumab), monoclonal antibody
ONCOLOGY - New indication
Opinions on drugs -
Posted on
May 11 2017
Reason for request
Extension of indication
Insufficient clinical benefit in combination with trastuzumab and chemotherapy, in the neoadjuvant treatment of HER2-positive breast cancer
- PERJETA has marketing authorisation in combination with trastuzumab and chemotherapy, in the neoadjuvant treatment of adults with HER2-positive breast cancer that is locally advanced, inflammatory or early stage with a high risk of recurrence.
- The clinical data available are mainly based on a proof-of-concept study and cannot be used to evaluate its effect size or its role in the neoadjuvant treatment of breast cancer.
Clinical Benefit
| Insufficient |
- |
Clinical Added Value
| Not applicable |
- |
Therapeutic use
|
- |
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