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Priority FDA Review for Celgene Drug

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Recently, Celgene Corporation (CELG - Free Report) 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.

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 irregularities).

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. , Medivation, Inc. and Targacept, Inc. are well placed currently. While Peregrine Pharma and Medivation carry a Zacks Rank #2 (Buy), Targacept carries a Zacks Rank #1 (Strong Buy).

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