HALAVEN (eribulin), antineoplastic agent
TRANSPARENCY COMMITTEE OPINION
Opinions on drugs -
Posted on
Dec 07 2017
Reason for request
Extension of Inclusion and
No clinical benefit demonstrated in the second-line treatment of locally advanced or metastatic breast cancer in patients in whom the disease has progressed, compared with the existing therapeutic strategy
Minor improvement in the treatment confirmed in third-line and later line of treatment of locally advanced or metastatic breast cancer that has progressed
- HALAVEN now has Marketing Authorisation in the treatment of locally advanced or metastatic breast cancer in patients in whom the disease has progressed after at least one chemotherapy protocol for the treatment of the advanced stage. The previous treatment, in the adjuvant or metastatic situation, must have included an anthracycline and a taxane, unless the patient cannot be given these treatments.
- In second-line treatment in a phase III study, no improvement in overall survival or in progression-free survival by comparison with XELODA (capecitabine) was demonstrated.
Clinical Benefit
Substantial |
- |
Clinical Added Value
minor |
- |
no clinical added value |
Therapeutic use
- |
-
Economic analysis
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