FDA Boost Sparks Competitio?n Between GSK and Roche

The accelerated approval of GSK’s melanoma combination therapy will create tough competition for Roche’s single-agent Zelboraf, according to independent analyst firm Datamonitor Healthcare.

GSK’s combination of Mekinist and Tafinlar, which is used to treat BRAF V600E and V600K mutation-positive melanoma, recently achieved first-to-market status thanks to accelerated approval from the FDA, propelling it ahead of Roche’s proposed combination therapy.

Dr Dominique Fontanilla, analyst at Datamonitor Healthcare said: “GlaxoSmithKline’s combination therapy for melanoma is extremely attractive as patients do not seem to develop resistance. This is likely to threaten Zelboraf’s revenues as patient resistance has been reported after 5 months.”

Dr Fontanilla continued: “The Mekinist and Tafinlar combination is able to simultaneously target the BRAF and MEK signalling pathways of malignant melanoma tumours.

“This has proven to be more clinically effective than monotherapies and we therefore expect it become a popular first-line treatment for this type of cancer.”

Although Mekinist and Tafinlar have struggled to compete with Roche’s Zelboraf following approval as single agents, it is predicted that they will gain significant uptake in combination and the drug is forecast to generate sales of $459 million by 2021 in the US, Japan and five major EU markets*.

*5 major EU markets: France, Germany, Italy, Spain, UK