Tafinlar

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Questions & Answers

On 23 February 2017, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Tafinlar. The marketing authorisation holder for this medicinal product is Novartis Europharm Ltd.

The CHMP adopted a new indication as follows:

“Non-small cell lung cancer (NSCLC)

Dabrafenib in combination with trametinib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a BRAF V600 mutation.”

For information, the full indications for Tafinlar will be as follows1:

“Melanoma

Dabrafenib as monotherapy or in combination with trametinib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation (see sections 4.4 and 5.1).

Non-small cell lung cancer (NSCLC)

Dabrafenib in combination with trametinib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a BRAF V600 mutation.”

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.


1 New text in bold

Name Language First published Last updated
CHMP post-authorisation summary of positive opinion for Tafinlar (English only) 2017-02-24  

Key facts

Product details for Tafinlar
NameTafinlar
INN or common name

dabrafenib

Therapeutic area Melanoma
Active substance

dabrafenib

Date opinion adopted23/02/2017
Company name

Novartis Europharm Ltd

StatusPositive
Application typePost authorisation