) and partner Genmab announced that they have submitted a
supplemental Biologics License Application (sBLA) to the U.S.
Food and Drug Administration (FDA) 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. The patients are inappropriate for
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The sBLA 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 in treatment-naive CLL patients versus Leukeran
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
We remind investors that GlaxoSmithKline and Genmab are also
looking to get Arzerra approved in combination with Leukeran for
the above mentioned indication in the EU and have submitted a
variation to the Marketing Authorisation Application for the
same. Meanwhile, Arzerra received Breakthrough Therapy
designation from the FDA in Sep 2013.
We note that 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 #2 (Buy).
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.
Currently, companies like
) are favorably placed in the pharma space with a Zacks Rank #1