GlaxoSmithKline submits cancer drugs for EU and US approval
7 August 2012 11:24 in Pharmaceutical Company Product News
GlaxoSmithKline has submitted a pair of new cancer drugs for approval by the European Medicines Agency and US Food and Drug Administration (FDA).
The company has applied for dabrafenib to be assessed by the EU regulator for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.
A similar application has been submitted for this compound in the US, while the FDA will also be evaluating GlaxoSmithKline's trametinib for the same indication.
The manufacturer has been working with BioMerieux since 2010 to develop a molecular theranostic test to detect BRAF V600 gene mutations found in several cancers, a test that will be used in conjunction with these new drugs.
Dr Rafael Amado, head of oncology research and development at GlaxoSmithKline, said: "We are planning to submit an application to the European Medicines Agency for trametinib in BRAF V600 mutation positive metastatic melanoma in the coming months."
Last month, the firm announced that it is also applying for US and European regulatory approval of Relvar, a new chronic obstructive pulmonary disease and asthma treatment.
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