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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.

 


Actual benefit

Faible

-

Insuffisant


Improvement in actual benefit

V (absence)

-


Therapeutic use

-

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