Ex-GSK Melanoma Therapy Secures EU Approval For Novartis
This article was originally published in Scrip
Novartis AG has been granted European approval for two products it picked up via a $20bn mega deal transaction with GlaxoSmithKline plc, a deal which closed in March this year.
Tafinlar (dabrafenib) and Mekinist (trametinib) both former GSK products, have been approved by the European Commission for use in combination to treat adults with metastatic melanoma.
While around 200,000 new cases of melanoma are diagnosed globally each year, according to the International Agency for Research on Cancer, analysts at Datamonitor Healthcare are not predicting a transformative sales impact following the approval of Novartis's new therapy considering pricing pressures on oncological drugs and competition from newer anti-PD1 (programmed death 1) treatments.
Tafinlar and Mekinist won a green light from the European Medicines Agency's scientific committee, the Committee for Medicinal Products for Human Use (CHMP), back in July as combination treatment for unresectable or metastatic melanoma with a BRAF V600 mutation.
Novartis believes that Tafinlar and Mekinist, which are both already approved as monotherapies, are potential blockbusters. However, Datamonitor does not think the new combo indication will bring more than a modest boost to sales of the two drugs.
The combination therapy has already been granted approval in the US, Australia, Canada and several other countries.
Marketing authorization in Europe is based on results from the Phase III COMBI-d and COMBI-v studies, in which the Tafinlar/Mekinist combination demonstrated overall survival (OS) benefit compared to Tafinlar and Daiichi-Sankyo's Zelboraf (vemurafenib) monotherapies respectively in patients with BRAF V600 mutation-positive unresectable or metastatic melanoma.