EMA Recommends Extensions of Indications for Dabrafenib and Trametinib

Combination is indicated for the treatment of adult patients with advanced NSCLC with a BRAF V600 mutation

On 23 February 2017, the European Medicines Agency’s (EMA’s) 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 products dabrafenib and trametinib.

The marketing authorisation holder for dabrafenib (Tafinlar) and trametinib (Mekinist) is Novartis Europharm Ltd.

The CHMP adopted a new indication for dabrafenib in non-small cell lung cancer (NSCLC) as follows: 

Dabrafenib in combination with trametinib is indicated for the treatment of adult patients with advanced NSCLC with a BRAF V600 mutation. 

The CHMP adopted a new indication for trametinib in NSCLC as follows: 

Trametinib in combination with dabrafenib is indicated for the treatment of adult patients with advanced NSCLC with a BRAF V600 mutation.

For information, the full indications for dabrafenib will be as follows:

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. 

NSCLC

Dabrafenib in combination with trametinib is indicated for the treatment of adult patients with advanced NSCLC with a BRAF V600 mutation.

For information, the full indications for trametinib will be as follows:

Melanoma

Trametinib as monotherapy or in combination with dabrafenib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.

Trametinib monotherapy has not demonstrated clinical activity in patients who have progressed on a prior BRAF inhibitor therapy.

NSCLC

Trametinib in combination with dabrafenib is indicated for the treatment of adult patients with advanced NSCLC with a BRAF V600 mutation.

Detailed recommendations for the use of these products will be described in the updated summaries of product characteristics, which will be published in the revised European public assessment report, and will be available in all official European Union languages after a decision on these changes to the marketing authorisations has been granted by the European Commission.

Summaries of positive opinions are published without prejudice to the Commission decision, which will normally be issued 67 days from adoption of the opinions.