GSK pulls EMA Tafinlar/Mekinist application
GlaxoSmithKline announced Wednesday that it pulled its request to have the European Medicines Agency review its request to approve Mekinist and Tafinlar as a duo to combat unresectable or metastatic melanoma with a BRAF V600 mutation.
The FDA approved this tandem use in January, but GSK said in a statement that it backed off of its EU request because it wanted to wait for data from an ongoing Phase-III clinical trial to come in first. Prompting the delay: The EMA's Committee for Medicinal Products for Human Use told the drugmaker that there wasn't enough data to make a “positive benefit-risk balance.”
GlaxoSmithKline says it will re-file the review request once it has sufficient data on hand.
The FDA's approval made Mekinist and Tafinlar the first combination oral therapy for these conditions.