Months before final-stage data are due, GSK files for U.S. approval for melanoma drug combination

LONDON (Reuters) – GlaxoSmithKline has filed for U.S. approval of a two-drug combination against melanoma earlier than many industry analysts expected, using data from a mid-stage clinical trial.

The move highlights a growing belief among drug companies that highly specific cancer drugs can prove their worth after relatively small-scale testing, speeding their path to market.

Britain’s biggest pharmaceuticals group said on Tuesday it had submitted the combination of dabrafenib and trametinib to the U.S. Food and Drug Administration based on data from a randomized Phase I/II study.

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Many investors had expected GSK to wait until it had received final-stage Phase III data on the drug combination, results of which are not due to come in until towards the end of this year.

The FDA gave a green light in May for the two drugs to be used separately. Both drugs are given as pills and are marketed under the brand names Tafinlar and Mekinist.

Tafinlar, or dabrafenib, belongs to a class of cancer drugs called BRAF inhibitors, while Mekinist, or trametinib, inhibits a protein associated with cancerous tumors known as MEK.

Together they are expected to produce a more effective and sustained treatment for melanoma, and combining them is seen as the main commercial opportunity for the medicines.