The US Food and Drug Administration (FDA) recently delivered
encouraging news to
) by approving the company's oncology drug, Pomalyst.
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Pomalyst was approved in the US in combination with low-dose
dexamethasone for the treatment of relapsed and refractory
multiple myeloma (MM) patients, who have received at least 2
prior therapies. Pomalyst has been approved to treat patients
whose cancer has worsened on or within 60 days of the last
We remind investors that Celgene had filed a new drug application
(NDA) with the FDA seeking approval for Pomalyst last year. The
FDA had granted standard review (10 month review period) to the
NDA for Pomalyst for the MM indication. The US regulatory body
cleared the drug a couple of days before the assigned target date
of Feb 10, 2013.
The FDA approval for Pomalyst came on the back of encouraging
data from a phase II study (MM-002) on the candidate.
Furthermore, in Dec 2012, the company announced encouraging data
from the international phase III study (MM-003), which evaluated
Pomalyst as a combination therapy in relapsed refractory multiple
myeloma patients. The patients did not respond favorably to
Takeda's Velcade and Celgene's Revlimid, administered either as a
monotherapy or in conjunction with other therapy/ies. Data
revealed that there was significant improvement in
progression-free survival and overall survival in patients in the
The approval of Pomalyst has further boosted Celgene's already
strong oncology product portfolio and should augment its top line
as the MM market offers significant commercial potential. We
remind investors that the FDA had approved another drug in the MM
space last year -
Onyx Pharmaceuticals, Inc.
Celgene, a biopharmaceutical company, currently carries a Zacks
Rank #3 (Hold). Biopharma stocks, such as
) presently appear to be more attractive. While Medivation
carries a Zacks Rank #2 (Buy), Targacept carries a Zacks Rank #1