CHMP recommends Tafinlar + Mekinist for adjuvant treatment of adult patients with stage III melanoma with a BRAF V600 mutation, following complete resection. Novartis.

Novartis has announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (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 (NEJM). 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. With an estimated 6,000 stage III BRAF mutant melanoma skin cancers diagnosed across Europe each year, this potential approval may provide patients in the EU the opportunity for a targeted combination therapy that doubles relapsed-free survival versus a placebo.