Trade Resources Industry Views GSK Has Announced Health Canada Approval of a BRAF-Inhibitor, Tafinlar

GSK Has Announced Health Canada Approval of a BRAF-Inhibitor, Tafinlar

GlaxoSmithKline (GSK) has announced Health Canada approval of a BRAF-inhibitor, Tafinlar, and a first in class MEK-inhibitor, Mekinist, for melanoma patients with BRAF V600 mutation.

Both, Tafinlar (dabrafenib mesylate) and Mekinist (trametinib), which need a validated test to identify BRAF V600 mutation status, are indicated as oral monotherapy for unresectable melanoma or metastatic melanoma in adult patients with BRAF V600 mutation.

GSK Canada R&D operations/business development vice president Rav Kumar said, "With Tafinlar and Mekinist, we hope to make a meaningful difference in the lives of patients living with metastatic melanoma, a devastating disease associated with very low survival rates and limited treatment options."

The company will make Tafinlar available in 50mg and 75mg capsules, while Mekinist in 0.5mg and 2.0mg tablets.

GlaxoSmithKline country medical director Glenn Crater said, "As a result, the approvals of Tafinlar and Mekinist are good news for this patient community and offer two new options for doctors and patients fighting this serious and deadly form of skin cancer."

 

Source: http://regulatoryaffairs.pharmaceutical-business-review.com/news/health-canada-clears-gsks-melanoma-drugs-for-patients-with-braf-v600-mutation-250713
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Health Canada Clears GSK's Melanoma Drugs for Patients with BRAF V600 Mutation