) announced that the U.S. Food and Drug Administration (FDA) has
granted priority review designation to the supplemental New Drug
Applications (sNDAs) 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.
The FDA is expected to render a decision on the Mekinist
supplement by Jan 8, 2014 and the Tafinlar supplement by Jan 9,
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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 has submitted
a marketing application for the same in Feb 2013.
We remind investors that both the melanoma drugs, Tafinlar and
Mekinist, received approval as monotherapy in the U.S. in May
2013. Other approved melanoma drugs include
Meanwhile, Glaxo was also in the news recently when the company
and Genmab announced that their oncology drug, Arzerra has
received Breakthrough Therapy designation from the FDA. The
companies are looking to get the candidate approved in
combination with Leukeran (chlorambucil) in treatment-naive
chronic lymphocytic leukaemia (CLL) patients, who have not been
previously treated for the disease and are inappropriate for
The FDA granted Breakthrough Therapy designation based on
encouraging results from a phase III trial (n > 400) which
evaluated the use of Arzerra in treat-naive CLL patients.
We note Arzerra is already approved for the treatment of patients
with CLL refractory to
) Campath (alemtuzumab) and Fludara (fludarabine).
Glaxo, a large cap pharma company, carries a Zacks Rank #3
(Hold). We are pleased with Glaxo's pipeline development efforts.
A number of pipeline-related news is expected in the coming
quarters. Given the declining sales due to generic competition,
we believe Glaxo's pipeline must deliver.
) are favorably placed in the large cap pharma space with a Zacks
Rank #2 (Buy).