GSK withdraws combined-use cancer drug application from EMA

Complaints about insufficient information has led GlaxoSmithKline to temporarily withdraw a European regulatory application for the combined use of two drugs to treat certain cancers. The FTSE 100 company had applied to the European Medicines Agency (EMA) to gain approval to market its trametinib/Mekinist inhibitor drug, which has been approved in the US, in combination with the previously EMA-approved BRAF-inhibitor dabrafenib/Tafinlar to treat adults with stage-four cancer melanomas with a BRAF V600 mutation.The Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) told GSK that the data provided so far did not allow it to come to any definite conclusions for this combination. GSK said it intended to reapply when it had produced further data from its ongoing Phase III programme.Dr Rafael Amado, Head of Oncology research and development at GSK, said: "Although we have withdrawn our application, we remain committed to providing further data from our ongoing Phase III development programme to support a subsequent re-submission in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. "While significant progress has been made in treating metastatic melanoma over the last few years, we believe more treatment options are needed, and we will work with the European regulators towards making the combination available for patients."OH