) and partner Genmab announced that they have submitted a
variation to the Marketing Authorisation Application (MAA) to the
European Medicines Agency (EMA) for their oncology drug, Arzerra
for an additional indication. The companies are looking to get
the drug 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 fludarabine-based therapy.
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The MAA was submitted on the basis of encouraging top-line data
from a phase III study (n = 447) on Arzerra. The study compared
the efficacy of Arzerra as an adjunct to another oncology drug at
Glaxo, Leukeran (chlorambucil) in treatment-naive CLL patients
versus Leukeran alone.
The study met its primary endpoint of progression free survival
(PFS/the time a patient lived without worsening of their
disease). Data from the study was assessed by an independent
review committee. In the Arzerra + Leukeran arm of the study,
median PFS of 22.4 months was observed as compared to 13.1 months
in the Leukeran arm, representing an improvement of 9.3 months.
The full data from the study will be presented at the American
Society of Hematology annual meeting, scheduled to be held in Dec
Meanwhile, Arzerra received Breakthrough Therapy designation from
the U.S. Food and Drug Administration (FDA). 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, since Oct 2009, 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 pharma space with a Zacks Rank #2