) announced that its melanoma drug, Mekinist has been cleared by
the European Commission (EC) as a single agent for the treatment of
adults suffering from unresectable or metastatic melanoma with a
BRAF V600 mutation. We note that Mekinist is only indicated for
patients who have confirmation of a BRAF V600 mutation using a
validated test and is not indicated for patients who have received
prior BRAF inhibitor treatment.
The EC recommendation was not surprising as the European Medicines
Agency's Committee for Medicinal Products for Human Use (CHMP) had
issued a positive opinion regarding the approval of Mekinist in Apr
Mekinist, which generated revenues of £13 million in the first
quarter of 2014, is currently approved in the U.S. both as
monotherapy and in combination with Tafinlar, another melanoma drug
Meanwhile, Glaxo and partner Genmab announced that the EC has
approved their cancer drug, Arzerra, for an additional indication.
Arzerra is now approved in the EU in combination with Glaxo's
Leukeran (chlorambucil) or
Teva Pharmaceutical Industries Limited
) Treanda (bendamustine) for the treatment of patients with chronic
lymphocytic leukemia (CLL) who have not received prior therapy and
who are not eligible for
) Fludara (fludarabine)-based therapy.
In this case too, the CHMP had issued a positive recommendation.
Arzerra is already approved in the EU for the treatment of patients
with CLL refractory to Sanofi's Campath (alemtuzumab) and Fludara
(fludarabine). We note that earlier this year, the FDA also
approved Arzerra in combination with Leukeran in treatment-naive
CLL patients for whom Fludara-based therapy is not suitable.
We believe that Arzerra's label expansion will significantly
increase the number of patients targeted by the drug and boost its
sales. Glaxo reported Arzerra revenues of approximately £16 million
in the first quarter of 2014.
Glaxo carries a Zacks Rank #3 (Hold). Better-ranked stocks in the
health care sector include
) carrying a Zacks Rank #2 (Buy).
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