Novartis skin cancer drug combo bags EC approval for type of melanoma
Novartis has secured approval from the European Commission (EC) for its skin cancer drug combo Tafinlar (dabrafenib) and Mekinist (trametinib) as an adjuvant therapy for stage III patients with BRAF V600 mutation-positive melanoma after complete surgical resection.
The latest approval marks the third for the Tafinlar-Mekinist combination in Europe for various tumor types identified with a high level of BRAF mutation.
It has been driven by results from the phase 3 COMBI-AD trial in 870 patients with stage III, BRAF V600E/K-mutant melanoma who did not have any prior anticancer therapy.
The primary endpoint of the trial was met in the primary analysis and following a median follow-up of 2.8 years, with the Tafinlar-Mekinist combination reducing the risk of recurrence or death by a significant extent to 53% in comparison to placebo.
Novartis said that updated data from the COMBI-AD trial, after a minimum follow-up of 40 months, showed that treatment with its skin cancer drug combo cut down the risk of recurrence or death by 51% in comparison to placebo.
Liz Barrett – CEO, Novartis Oncology, commenting on the approval of the Tafinla Mekinist skin cancer drug combo, said: “Novartis’ deep therapeutic knowledge and our ability to apply novel approaches to the development of new medicines has resulted again in a new treatment advance for melanoma patients.
“The European approval of the Tafinlar and Mekinist combination illustrates Novartis’ continued efforts to reimagine cancer by providing a highly effective, targeted therapy for earlier-stage melanoma patients.”
Prior to the EC approval, the Tafinlar and Mekinist combination was endorsed by the Committee for Medical Products for Human Use of the European Medicines Agency in July. A couple of months or so before that, the Novartis skin cancer drug combo bagged an approval from the US Food and Drug Administration as an adjuvant therapy for melanoma.