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TAFINLAR (dabrafenib), tyrosine kinase inhibitor
ONCOLOGY - New medicinal product
Opinions on drugs -
Posted on
Mar 23 2015
Reason for request
Inclusion
No clinical benefit demonstrated by comparison with dacarbazine in the current management of unresectable or metastatic melanoma with a BRAF V600 mutation
- TAFINLAR has Marketing Authorisation as monotherapy in the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.
- Its efficacy has been demonstrated in terms of the improvement in progression-free survival by comparison with dacarbazine but with no increase in overall survival.
- No direct comparison with ZELBORAF (vemurafenib) is available.
Clinical Benefit
| Substantial |
The actual benefit stated for TAFINLAR is substantial. |
Clinical Added Value
| no clinical added value |
TAFINLAR does not provide an improvement in actual benefit (level V, non-existent) in the current treatment of unresectable or metastatic melanoma with a BRAF V600 mutation. |
