Novartis today 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.
"Melanoma is an aggressive, highly recurrent and often fatal disease. In advanced melanoma, we've demonstrated the ability to reduce the risk of death or recurrence by more than half," said Liz Barrett, CEO, Novartis Oncology. "Today's CHMP opinion brings us another step closer to reimagining earlier stage therapy for patients throughout Europe and making strides to bring improved outcomes for people living with melanoma."
"These relapse-free survival results are unprecedented," said lead investigator Axel Hauschild, MD, PhD, Professor of Dermatology, University Hospital Schleswig-Holstein, in Kiel, Germany. "The overall survival improvements also demonstrated by Tafinlar in combination with Mekinist, among other key secondary endpoints, are encouraging in the treatment of stage III BRAF V600E/K mutation-positive melanoma. Adjuvant treatment options are critical for this patient community at risk for recurrence."