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HERCEPTIN (trastuzumab), monoclonal antibody

TRANSPARENCY COMMITTEE OPINION
Opinions on drugs - Posted on Jun 23 2016

Reason for request

Re-assessment of the improvement in actual benefit

Moderate clinical added value in combination with a taxane and pertuzumab as a first-line treatment for HER2+ metastatic breast cancer that has not been previously treated.

No demonstrated clinical benefit in combination with an aromatase inhibitor as a first-line treatment for HER2+ metastatic breast cancer that has not been previously treated.

  •   HERCEPTIN has marketing authorisation in the treatment of HER2+ metastatic breast cancer:

 -     in combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable;

 -     in combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease;

 -     in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive MBC, not previously treated with trastuzumab.

  • HERCEPTIN in combination with a taxane remains the standard treatment in HER2+ metastatic breast cancer that has not been previously treated, however, the addition of pertuzumab to this dual therapy is now recommended.
  • No data are available to document the efficacy of HERCEPTIN in combination with an aromatase inhibitor in situations where it could be a first-line treatment for HER2+ metastatic breast cancer.

 

Insufficient clinical benefit as a third-line monotherapy in HER2+ metastatic breast cancer

  • HERCEPTIN has marketing authorisation as a monotherapy in the treatment of HER2+ metastatic breast cancer in patients who have already been treated by at least two chemotherapy protocols.
  • This indication relies on data of very poor methodological quality which does not permit quantifying its contribution in this indication.
  • Patients currently treated for HER2+ metastatic breast cancer have all received trastuzumab as a first-line treatment, so this indication is now obsolete. Trastuzumab as a monotherapy is no longer part of the recommended therapeutic options at this stage of the disease, although it could be recommended to maintain an anti-HER2 blockade.

 

 

 

 

 


Actual benefit

Important

-

Insuffisant


Improvement in actual benefit

III (modéré)

-

V (absence)


Therapeutic use

-

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