AVASTIN (bevacizumab), monoclonal antibody
ONCOLOGY - Focus
Opinions on drugs - Posted on Oct 14 2016
Reason for request
Re-assessment of the improvement in actual benefit
No clinical benefit demonstrated in first-line treatment of metastatic colorectal cancer by comparison with anti-EGFR treatments (VECTIBIX or ERBITUX) in combination with a fluoropyrimidine-based chemotherapy, in case of wild-type RAS tumour.
Minor improvement in combination with chemotherapy compared to that same chemotherapy administered alone as first-line treatment, in case of mutated RAS tumour
- In colorectal cancer, AVASTIN has Marketing Authorisation, in combination with a fluoropyrimidine-based chemotherapy, in adults with metastatic colorectal cancer,
- In case of a wild-type RAS tumour, the lack of superiority was confirmed in terms of survival with AVASTIN compared to an anti-EGFR, associated with fluoropyrimidine-based chemotherapy.
- In case of a mutated RAS tumour, the addition of AVASTIN to chemotherapy versus chemotherapy alone allows a gain in overall survival, observed only in the pivotal study and a gain in progression-free survival in 2 out of 3 studies (gain of 1.4 to 4 months).
Clinical Added Value
|no clinical added value|
Évaluation des médicaments