GSK seeks EU approval of trametinib, dabrafenib

GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) submitted an MAA to EMA for trametinib as monotherapy and in combination with the pharma's dabrafenib to treat unresectable or metastatic melanoma with BRAF V600 mutations. GSK said EMA's CHMP granted its request for accelerated assessment, which will shorten the review period to 150 days from 210. An MAA for dabrafenib as monotherapy in the indication is already under review under a standard assessment.

Neither trametinib nor dabrafenib has regulatory approval anywhere in the world. GSK said that it "worked very closely with EU regulators on the submission to make sure it was appropriate," but declined to disclose details. EMA could not be reached for details on how it will evaluate applications for combinations of unapproved products. ...