GSK Announces Submission of Melanoma Drugs

GlaxoSmithKline plc announced regulatory submissions in the European Union and United States related to single-agent use of its BRAF inhibitor dabrafenib and MEK inhibitor trametinib to treat patients with BRAF V600 mutation positive metastatic melanoma, specifically:

· A Marketing Authorization Application to the European Medicines Agency for dabrafenib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.

· A New Drug Application to the United States Food and Drug Administration for dabrafenib for the treatment of patients with unresectable or metastatic melanoma with BRAF V600 mutation as detected by an FDA-approved test.

· A New Drug Application to the United States Food and Drug Administration for trametinib for the treatment of patients with unresectable or metastatic melanoma with BRAF V600 mutations as detected by an FDA-approved test.

“These regulatory submissions represent important progress in our oncology pipeline,” said Rafael Amado, MD, head of oncology R&D at GSK. “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.”

GSK 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 III trametinib-dabrafenib combination program to identify appropriate patients.

SOURCE: GSK