GSK today announced that the US Prescription Drug User Fee Act (PDUFA) goal date for trametinib, its MEK inhibitor, has been extended by 3 months to 3 September 2013.
The company recently submitted additional manufacturing data to the Food and Drug Administration (FDA) and the extension to the original PDUFA goal date is to allow sufficient time for FDA to review the submission.
On 3 August 2012, GSK announced submission of a New Drug Application for trametinib as a treatment for patients with unresectable or metastatic melanoma with BRAF V600 mutations as detected by an FDA-approved test.
On 7 February 2013, GSK announced submission of a Marketing Authorization Application to the European Medicines Agency (EMA) for trametinib monotherapy and in combination with dabrafenib as a treatment for patients with unresectable or metastatic melanoma with BRAF V600 mutations.
The new manufacturing information submitted to FDA will also be shared with the EMA according to the standard centralized review process.