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BRIEF-GSK withdraws European application for skin cancer drugs combination
March 26, 2014 / 10:21 AM / 4 years ago

BRIEF-GSK withdraws European application for skin cancer drugs combination

March 26 (Reuters) - GlaxoSmithKline Plc : * Regulatory update on combined use of MEK/BRAF * Application for use of Mekinist as a single agent in the same patient

population is still undergoing review by the ema * Says remain committed to providing further data from our ongoing phase III

development programme to support a subsequent re-submission in Europe * Has withdrawn marketing authorisation application to European medicines

agency for the use of Mekinist in combination with BRAF inhibitor Tafinlar * To re-submit the MAA for the combined use of Tafinlar and Mekinist when

additional data from the ongoing phase III become available * Says will work with the European regulators towards making the combination

available for patients * CHMP of EMA has indicated that data provided by GSK did not allow committee

to conclude on a positive benefit-risk balance of the combination * Source text for Eikon: * For more news, please click here

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