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Recently, GlaxoSmithKline (GSK - Analyst Report) announced that it has submitted a regulatory application for its oncology candidate, trametinib, as a monotherapy, for the BRAF V600 mutation-positive metastatic melanoma indication to the European Medicines Agency (EMA).

The company is also looking to get trametinib in combination with another oncology candidate, dabrafenib, approved for use in adults with BRAF V600 mutation-positive metastatic melanoma.

Glaxo’s application seeking approval of trametinib as a monotherapy as well as combination therapy has been granted accelerated assessment by EMA’s Committee for Medicinal Products for Human Use (CHMP). A final decision by the European Commission (EC) is expected by mid-Jul 2013.

Glaxo submitted the marketing application primarily on the basis of encouraging data from a phase III study of trametinib as a single agent. The trial evaluated the use of trametinib versus dacarbazine or paclitaxel monotherapy in BRAF V600 mutation positive metastatic melanoma patients.

The application also included promising data from a phase I/II study which compared the combination of dabrafenib and trametinib with dabrafenib alone in patients with BRAF V600 mutation positive metastatic melanoma.

We note that dabrafenib, as a monotherapy, is under review in the US and Europe for the BRAF V600 mutation-positive metastatic melanoma indication.

Additionally, in Aug 2012, Glaxo submitted a new drug application to the US Food and Drug Administration (FDA) for trametinib, as a monotherapy, for the BRAF V600 mutation-positive metastatic melanoma indication.

We note that Glaxo has a robust pipeline. A number of pipeline-related news is expected in the coming quarters. We believe that Glaxo’s pipeline must deliver since many of its products are facing declining sales due to generic competition.

Glaxo carries a Zacks Rank #4 (Sell) in the short run. Large-cap pharma companies that currently look better-positioned include Sanofi (SNY - Analyst Report), Eli Lilly and Company (LLY - Analyst Report) and Bayer (BAYRY - Analyst Report). All the three companies carry a Zacks Rank #2 (Buy).

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