Recently, GlaxoSmithKline (GSK) 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), Eli Lilly and Company (LLY) and Bayer (BAYRY). All the three companies carry a Zacks Rank #2 (Buy).
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