Ready to challenge Novartis and Roche, Array scores FDA nod for melanoma combo

Twenty years after it began, Array BioPharma has its first two drug approvals, a cancer drug combo that'll transform care for certain melanoma patients, the company's CEO says. But they'll face a couple of heavyweight pharmas in the field.

The combo of Mektovi, a MEK inhibitor, and Braftovi, a BRAF inhibitor, won FDA approval to treat patients with melanoma that can't be surgically removed or has spread through the body, provided the tumors have BRAF V600E or V600K mutations. According to AIM at Melanoma Foundation co-founder and president Valerie Guild, nearly half of metastatic melanoma patients test positive for the mutation.

Data from a phase 3 trial against Roche's Zelboraf, which showed Array's combo beat the Roche...