) recently announced that Oncologic Drugs Advisory Committee (ODAC)
of the US Food and Drug Administration (FDA) will hold a meeting on
November 8, 2012 to review the company's new drug application (NDA)
for its oncology candidate, pomalidomide.
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Celgene is seeking approval of the candidate in combination with
low-dose dexamethasone for the treatment of relapsed and refractory
multiple myeloma (MM) patients, who have received at least two
We remind investors that the FDA had granted standard review (10
month review period) to the NDA for pomalidomide for the MM
indication. The NDA includes data from a phase II study (MM-002) on
the candidate. Celgene is also conducting an international phase
III study (MM-003), evaluating pomalidomide in relapsed and
refractory MM patients. Data from the study is expected by year
A final decision from the FDA is expected by February 10, 2013
(action date). The decision on pomalidomide is an eagerly-awaited
event. Celgene is also seeking European approval for pomalidomide
for the same indication.
The MM market has been in the spotlight this year. In July 2012,
the FDA cleared
Onyx Pharmaceuticals, Inc.
) Kyprolis. Kyprolis was approved for use in treatment-experienced
MM patients (who have received at least two prior therapies,
Johnson & Johnson
) Velcade and an immunomodulatory agent). Moreover, the disease had
progressed on or within 60 days of completion of the last therapy
in those patients.
We note another key action date is coming up at Celgene next month
(October 12) when the FDA is expected to decide on the company's
efforts to expand the label of its oncology drug, Abraxane, into
the non-small cell lung cancer (NSCLC) indication. Celgene is
looking to get Abraxane approved as a first-line therapy in
advanced NSCLC patients. Abraxane is already available as a
second-line therapy for metastatic breast cancer.
We currently have a Neutral recommendation on Celgene. The stock
carries a Zacks #3 Rank (Hold rating) in the short run.