) announced that the US Food and Drug Administration (FDA) will
review the supplemental New Drug Application (sNDA) for cancer
drug Revlimid (lenalidomide) on a priority basis.
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Revlimid, the key growth driver at Celgene, 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 (MDS) associated with a deletion 5q cytogenetic
abnormality (with or without additional cytogenetic
Celgene is now looking to get the drug approved for treating
patients suffering from relapsed refractory mantle cell lymphoma
(MCL). The patients had been previously treated for the disease
by drugs including Takeda's Velcade. The sNDA was filed by
Celgene in late 2012 on the basis of encouraging data from a
phase II study (EMERGE) which evaluated Revlimid in the
indication. A response from the FDA is expected to be out by Jun
5, 2013 (target date).
We note that the US regulatory authority generally reviews those
drugs on a priority basis which offer major advances in treating
diseases having no adequate therapy. Applications for priority
review designated drugs are reviewed by the FDA within six months
of submission as against the usual ten months.
Celgene received another good news when the China State Food and
Drug Administration cleared Revlimid for the MM indication. The
company intends to launch Revlimid for the indication in China in
the second quarter of this year. The approval of Revlimid for MM
in the high-potential Chinese market should boost the drug's
sales potential significantly.
Celgene, a biopharmaceutical company, currently carries a Zacks
Rank #3 (Hold). Biopharma stocks, such as
Peregrine Pharmaceuticals, Inc.
) are well placed currently. While Peregrine Pharma and
Medivation carry a Zacks Rank #2 (Buy), Targacept carries a Zacks
Rank #1 (Strong Buy).