EMA Recommends Extension of Indications for Dabrafenib and Trametinib

New indication concerns combination of two drugs in the adjuvant treatment of completely resected stage III melanoma with a BRAF V600 mutation

On 26 July 2018, 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 (Tafinlar) and trametinib (Mekinist). 

The marketing authorisation holder for Tafinlar and Mekinist is Novartis Europharm Limited. 

The CHMP adopted an extension to an existing indication as follows: 

  • Dabrafenib in combination with trametinib is indicated for the adjuvant treatment of adult patients with stage III melanoma with a BRAF V600 mutation, following complete resection.
  • Trametinib in combination with dabrafenib is indicated for the adjuvant treatment of adult patients with stage III melanoma with a BRAF V600 mutation, following complete resection.

For information, the full indications for Tafinlar 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. 

Adjuvant treatment of melanoma

Dabrafenib in combination with trametinib is indicated for the adjuvant treatment of adult patients with stage III melanoma with a BRAF V600 mutation, following complete resection. 

Non-small cell lung cancer (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 Mekinist 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.

Adjuvant treatment of melanoma

Trametinib in combination with dabrafenib is indicated for the adjuvant treatment of adult patients with stage III melanoma with a BRAF V600 mutation, following complete resection. 

NSCLC

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

Recommendations

Detailed recommendations for the use of these products will be described in the updated summary of product characteristics, which will be published in the revised European public assessment reports and will be available in all official European Union languages after a decision on the change 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.