GSK pulls EMA Tafinlar/Mekinist application
GSK backed off of its EU request because it wanted to wait for more data
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.