NDAs Submitted for Dabrafenib and Trametinib for Unresectable or Metastatic Melanoma

GlaxoSmithKline announced that it has submitted New Drug Applications (NDAs) for dabrafenib and trametinib to the FDA, seeking approval for the treatment of patients with unresectable or metastatic melanoma with BRAF V600 mutation as detected by an FDA-approved test.

GlaxoSmithKline entered a collaboration with bioMérieux in 2010 to develop a molecular theranostic test to detect BRAF V600 (V600E and V600K) gene mutations found in several cancers, including melanoma. bioMérieux has filed for FDA Pre-Market Approval of the test and it is currently being utilized in the Phase 3 trametinib-dabrafenib combination program to identify appropriate patients.

Dabrafenib is a BRAF inhibitor. Trametinib is an MEK inhibitor.

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