Posted by Michael Wonder on 28 Jul 2018
Novartis combination Tafinlar + Mekinist receives positive CHMP opinion for adjuvant treatment of BRAF V600 mutation-positive melanoma
27 July 2018 - If approved, expected to be the first targeted combination therapy in the EU for adjuvant treatment of melanoma.
Novartis today announced the CHMP of the EMA has adopted a positive opinion recommending approval of Tafinlar (dabrafenib) in combination with Mekinist (trametinib) for the adjuvant treatment of adult patients with stage III melanoma with a BRAF V600 mutation, following complete resection. The CHMP recommendation is based on findings from the COMBI-AD study, which was published in The New England Journal of Medicine.
Patients who have been diagnosed with stage III melanoma are at a higher risk of recurrence after surgical resection. The COMBI-AD study found a statistically significant 53% reduction in the risk of recurrence or death in patients treated with the BRAF and MEK inhibitor combination therapy after surgical resection versus placebo.
