Revlimid Priority FDA Review

[KP2112]

Hi Everyone,

The FDA has decided to give Revlimid Priority Review. A decision is expected October 7, 2005, please read below.

06/21/05 – FDA Grants Priority Review for Celgene’s REVLIMID® (lenalidomide) New Drug Application with Review and Decision Expected by October 7, 2005

Tuesday, June 21, 2005 – Celgene Corporation announced in their press release that the U.S. Food and Drug Administration (FDA) has granted priority review designation to its New Drug Application (NDA) for REVLIMID® based on Phase II clinical trial data. Celgene is seeking approval to market Revlimid® as a treatment for transfusion-dependent patients with myelodysplastic syndromes (MDS) with 5q deletion chromosomal abnormality. NDAs with priority review receive expedited treatment, with the target review period for the application reduced from ten months to six months. The FDA expects to complete their review and decision by October 7, 2005 after an FDA review team has evaluated whether the clinical trial data the sponsor submitted show that the drug is safe and effective for its proposed use. Read more in Celgene’s press release at http://www.celgene.com.

Thanks,
Karen

[Suzanne]

Interesting that the approval is only being applied for in the cases with the 5q-. I knew they had better results for those patients but I did not know it was being exclusively used with those patients. Every little bit helps.

[Carl]

Great news Karen. Thanks for the update.

[Author]

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