) 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
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
Glaxo carries a Zacks Rank #4 (Sell) in the short run.
Large-cap pharma companies that currently look better-positioned
Eli Lilly and Company
). All the three companies carry a Zacks Rank #2 (Buy).
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