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TRANSPARENCY COMMITTEE OPINION

AVASTIN (bevacizumab), monoclonal antibody

Active substance (DCI)
  • bevacizumab
ONCOLOGY - New indication

Reason for request
Extension of Inclusion

Date 01 April 2015

Indications concerned
-

No clinical added value demonstrated in treatment of the first recurrence of platinum-sensitive ovarian cancer or the recurrence of platinum-resistant ovarian cancer.

  • AVASTIN has Marketing Authorisation :

- in combination with carboplatin and gemcitabine, in the treatment of the first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer ;

in combination with paclitaxel, with topotecan or with pegylated liposomal doxorubicin, in the case of recurrence of platinum-resistant recurrent epithelial ovarian, fallopian tube, and primary peritoneal cancer.

  • The addition of bevacizumab to the chemotherapy has been shown to have a moderate effect on progression-free survival, without a demonstrated increase in overall survival and quality of life but with an increase in toxicity, particularly vascular toxicity.




Actual benefit

Important

-


Improvement in actual benefit

V (absence)

-


Therapeutic use

-

Documents

English version

ATC Code
  • L01XC07
Laboratory / Manufacturer
ROCHE SAS

Presentation

-

Posted on Jan 18 2016