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.