) recently announced that it has submitted supplemental New Drug
Applications (sNDA) to the US Food and Drug Administration (FDA)
for the Tafinlar (dabrafenib)-Mekinist (trametinib) combination.
The company is looking to get Tafinlar in combination with
Mekinist approved for the BRAF V600 E or K mutation-positive
unresectable or metastatic melanoma indication.
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The regulatory applications contain data from a phase I/II study
evaluating Tafinlar in combination with Mekinist versus Tafinlar
alone in patients suffering from BRAF V600E or K mutation
positive metastatic melanoma. The company is also looking to get
the combination therapy approved in Europe for use in adults with
BRAF V600 mutation-positive metastatic melanoma and submitted a
marketing application for the same in Feb 2013. Glaxo has also
submitted marketing application for Mekinist as a monotherapy in
We remind investors that both the melanoma drugs, Tafinlar and
Mekinist, received approval as monotherapy in the US in May 2013.
The FDA approved Tafinlar for BRAF V600E mutation-positive
unresectable or metastatic melanoma patients. However, Tafinlar
is not recommended for patients suffering from wild-type BRAF
melanoma. The FDA also cited several warnings and precautions
related to the use of Tafinlar, which can lead to fatal side
effects including increasing the risk of developing new primary
Mekinist was approved for the treatment of patients suffering
from unresectable or metastatic melanoma with BRAF V600E or V600K
mutations. Mekinist has not been approved for treating patients
who have received a prior BRAF inhibitor treatment.
Glaxo intends to launch the drugs in the US by early third
quarter 2013. Currently approved melanoma drugs include
) Zelboraf and
Bristol-Myers Squibb Co.
Glaxo carries a Zacks Rank #3 (Hold). We are pleased with Glaxo's
label expansion efforts. Moreover, Glaxo boasts of a robust
pipeline. A number of pipeline-related news is expected in the
coming quarters. Given the declining sales from generic
competition, we believe Glaxo's pipeline must deliver. Companies
that currently look attractive include
Valeant Pharmaceuticals International, Inc.
) carrying a Zacks Rank #1 (Strong Buy).