) received encouraging news recently with the US Food and Drug
Administration (FDA) clearing the company's growth engine
Revlimid for an additional indication. The US regulatory body
approved Revlimid for treating patients suffering from mantle
cell lymphoma (MCL). The disease of the patients had either
relapsed or worsened after two prior therapies, including
Takeda Pharmaceutical Company
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The US approval came on the basis of encouraging data from a
multi-center, single arm, open label phase II study (MCL-001:
n=134) which evaluated Revlimid in the MCL indication. We remind
investors that Celgene had filed a supplemental New Drug
Application (sNDA), seeking FDA approval to expand Revlimid's
label, late last year. The FDA reviewed the application on a
priority basis. The US regulatory body gave its nod of approval
on its assigned target date of Jun 5, 2013.
We note that Revlimid is already approved in combination with
dexamethasone for treating multiple myeloma (MM) patients who
have received at least one prior therapy. Revlimid is also
available for treating transfusion-dependent anemia due to low-
or intermediate-1-risk myelodysplastic syndrome associated with a
deletion 5q cytogenetic abnormality (with or without additional
cytogenetic irregularities). The label expansion into the MCL
indication would further boost the sales potential of the drug.
We note that the positive news from the FDA came close on the
heels of the European Medicines Agency's (EMEA) Committee for
Medicinal Products for Human Use (CHMP) recommending the EU
approval of another drug at Celgene, Pomalyst.
Celgene is seeking approval for the use of Pomalyst in
combination with low-dose dexamethasone for the treatment of
relapsed and refractory MM patients, who have received at least
two prior therapies (including Revlimid and Velcade). The disease
worsened for the patients while on their previous therapy. We
note that Pomalyst is already available in the US for the MM
Celgene, a biopharmaceutical company, currently carries a Zacks
Rank #2 (Buy).
Alexion Pharmaceuticals, Inc.
Cubist Pharmaceuticals, Inc.
(CBST) look equally attractive in the biopharma space with a
Zacks Rank #2 each.