) announced that it has received approval from the US Food and
Drug Administration (FDA) for a label expansion of its cancer
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Celgene gained approval to use Abraxane as a first-line
combination therapy for treating patients suffering from locally
advanced or metastatic non-small cell lung cancer (NSCLC).
Curative surgery or radiation therapy is not applicable for those
The FDA approval of Abraxane for the additional indication was
based on positive results from a phase III study (CA-031). We
note that Abraxane is already available in the US as a
second-line therapy for metastatic breast cancer. Approval for
the new indication has boosted Abraxane's sales potential.
The NSCLC market is highly crowded and includes players, such as
Eli Lilly and Company
We note that Celgene is also seeking approval for the NSCLC
indication in Japan, Australia and New Zealand. The regulatory
authorities in those countries are expected to decide on the
matter in 2013.
Moreover, Abraxane is being developed for other indications, such
as metastatic pancreatic cancer (phase III MPACT study, data
expected by year-end/the first quarter of 2013).
We note that an eagerly awaited event at Celgene concerns its
oncology candidate, pomalidomide. Celgene is seeking approval of
the candidate in combination with low-dose dexamethasone for the
treatment of relapsed and refractory multiple myeloma patients,
who have received at least two prior therapies. A final decision
from the FDA is expected by February 10, 2013 (action date).
We currently have a Neutral recommendation on Celgene. The stock
carries a Zacks #3 Rank (Hold rating) in the short run.