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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.
Clinical Benefit
| Substantial |
- |
| Insufficient |
Clinical Added Value
| moderate |
- |
| no clinical added value |
Therapeutic use
|
- |
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