Primo-indication
MelanomaTrametinib 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 (see sections 4.4 and 5.1).Trametinib monotherapy has not demonstrated clinical activity in patients who have progressed on a prior BRAF inhibitor therapy (see section 5.1).Adjuvant treatment of melanomaTrametinib 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.Non-small cell lung cancer (NSCLC)Trametinib in combination with dabrafenib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a BRAF V600 mutation.
Intervention Type
Pharmaceutical
Solid/Hematological
Solid
Cancer Type
Melanoma
Therapy Types
Targeted Therapy
Regulatory
FDA
Regulatory Pathway: n/a
EMA
Regulatory Pathway: standard approval
Availability in other countries
N/A
Focus Area
Cancer
ASMR
III
Medical Need
Partially met
SMR
IMPORTANT
Orphan Status
No