AVASTIN (bevacizumab), monoclonal antibody - BREAST CANCER
TRANSPARENCY COMMITTEE OPINION
Opinions on drugs - Posted on Jun 23 2016
Reason for request
Re-assessment of the improvement in actual benefit
Low clinical interest without demonstrated clinical benefit in combination with paclitaxel relative to paclitaxel alone in the first-line management of HER2 negative metastatic breast cancer.
Insufficient clinical interest in combination with capecitabine in the first-line management of HER2 negative metastatic breast cancer.
- AVASTIN has marketing authorisation in HER2 negative metastatic breast cancer as a first-line treatment in combination with paclitaxel or in combination with capecitabine in patients for whom treatment with other chemotherapy options, including taxanes or anthracyclines, is not considered appropriate.
- In combination with paclitaxel, the addition of bevacizumab to paclitaxel (or taxane/anthracycline) modestly improved progression-free survival relative to paclitaxel alone, without demonstrating improvement of overall survival. New observational data have not demonstrated, with a sufficient level of evidence, the benefit on overall survival of the addition of bevacizumab to paclitaxel relative to paclitaxel alone.
- In combination with paclitaxel, bevacizumab remains a first-line treatment alternative for HER2 negative metastatic breast cancer.
- Its role in the subpopulation of HER2-negative and Rh-negative patients (triple negative) cannot be specified in the absence of data.
- In combination with capecitabine, the clinical benefit of this combination is insufficient to justify reimbursement by National Health Insurance.
Improvement in actual benefit
Évaluation des médicaments