) recently announced that its oncology drug, Abraxane, has
performed well in a phase III study (CA033: n=529). The randomized,
open-label, international study compared Abraxane with the standard
chemotherapy treatment dacarbazine (DTIC) in chemotherapy-naïve
patients suffering from metastatic melanoma, a form of skin
The encouraging pipeline related news had a positive impact on
Celgene's shares. Data from the study revealed that patients
treated with Abraxane survived longer without the disease worsening
compared to those in the DTIC arm. Abraxane, on being approved for
this indication, would compete with drugs such as
) Zelboraf, in the metastatic melanoma space.
We note that Abraxane is already available as a second-line
therapy for metastatic breast cancer. The drug is being studied for
many other indications.
Even though impressed by the positive news on Abraxane for the
metastatic melanoma indication, we believe that investor focus will
remain on the US approvability status of Abraxane in the advanced
non-small cell lung cancer (NSCLC) indication. The US Food and Drug
Administration (FDA) is expected to decide on Abraxane's label
expansion into the NSCLC indication later in the month (target
date: October 12).
Moreover, the drug 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). Positive news
regarding Abraxane would further boost the stock.
Apart from news regarding the label expansion of Abraxane,
another eagerly awaited event at Celgene concerns its other
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.
CELGENE CORP (CELG): Free Stock Analysis Report
(RHHBY): ETF Research Reports
To read this article on Zacks.com click here.