Tafinlar is a medicine that contains the active substance dabrafenib. It is used in adults to treat a type of skin cancer called melanoma when the cancer has spread to other parts of the body or cannot be removed by surgery. Tafinlar is either used on its own or in combination with another medicine, Mekinist, which contains the active substance trametinib (Mekinist).

Tafinlar in combination with Mekinist is also used to prevent melanoma from coming back after it has been removed by surgery. Melanoma can be associated with a particular change (mutation) in a gene called BRAF at the V600 position. This mutation in the gene may have caused the cancer to develop. The medicines Tafinlar and Mekinist target proteins made from this mutated gene and slow down or stop the growth and development of melanoma.

Both Tafinlar and Mekinist are licensed for use as individual therapies or as a combination to treat people who have this BRAF mutation and have unresectable (cannot be surgically removed) or metastatic (has spread to another organ, Stage IV) melanoma. Tafinlar + Mekinist is also licensed for use in stage III melanoma where it is used in combination to treat people who have undergone surgery.

Approved uses of Tafinlar + Mekinist

Tafinlar + Mekinist combination therapy is approved for use in treating adult patients with unresectable or metastatic melanoma that is positive for the BRAF V600 mutation.

Tafinlar + Mekinist combination therapy is approved for the treatment of adult patients with BRAF-positive stage III melanoma following complete surgical removal.

Summary of Product Characteristics for Tafinlar + Mekinist

These links will take you to the emc website, which is a non-Novartis website.

SmPC for Tafinlar 

SmPC for Mekinist 

Patient Information Leaflet for Tafinlar + Mekinist

These links will take you to the emc website, which is a non-Novartis website.

PIL for Tafinlar 

PIL for Mekinist 

 

Abbreviations: emc, electronic medicines compendium; PIL, patient information leaflet; SmPC, Summary of Product Characteristics.

ONC20-C023(1) September 2020.
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Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You should also report side effects directly via the Yellow Card Scheme at yellowcard.mhra.gov.uk.
By reporting side effects you can help provide more information on the safety of this medicine.