Basic Information
Mekinist
Regulatory Information
EMEA/H/C/002643
June 30, 2014
June 30, 2020
36
December 5, 2024
Company Information
Ireland
Vista Building Elm Park Merrion Road Dublin 4
NOVARTIS EUROPHARM LIMITED
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication **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 (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 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. **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.
Overview Summary
Mekinist is a cancer medicine used to treat adults whose cancer cells have a specific genetic mutation (change) in their genes called 'BRAF V600'. It is used for the treatment of: - melanoma (a skin cancer) that has spread or cannot be removed surgically. Mekinist is used on its own or in combination with another cancer medicine, dabrafenib; - advanced (stage III) melanoma after surgery for it. Mekinist is used in combination with dabrafenib; - advanced non-small cell lung cancer. It is used in combination with dabrafenib. Mekinist contains the active substance trametinib.