LONDON (Alliance News) - GlaxoSmithKline PLC Wednesday said it had withdrawn its marketing authorisation application for the combined use of Meikinist and Tafinlar for the treatment of unresectable or metastatic melanoma with a BRAF V600 mutation in Europe.
This was as a result of the Committee for Medicinal Products for Human Use within the European Medicines Agency indicating that the data provided by Glaxo had not allowed it to conclude on a benefit of the combined treatment.
Glaxo said that it will re-submit its application for the combined treatment when it has further data from its ongoing Phase III programme.
The application for Mekinist for use as a single agent is still undergoing review with the European Medicines Agency.
"Although we have withdrawn our application, we remain committed to providing further data from our ongoing Phase III development programme to support a subsequent re-submission in Europe," said Head of Oncology research and development at GlaxoSmithKline Rafael Amado.
Shares in Glaxo were trading up 0.3% at 1,626.50 pence Wednesday morning.
By Hana Stewart-Smith; hanassmith@alliancenews.com; @HanaSSAllNews
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