FDA panel backs Celgene’s Revlimid

BOSTON — A Food and Drug Administration advisory panel has voted to recommend that the agency approve Celgene Corp.’s oncology drug Revlimid, the company said Wednesday.

By Val Brickates Kennedy, MarketWatch
Last Update: 1:19 PM ET Sept. 14, 2005

Trading in shares of Summit, N.J.-based Celgene was halted at $52.91
Wednesday morning, ahead of the meeting. Celgene is seeking to have the drug Revlimid approved for the treatment of transfusion-dependent anemia due to certain blood cancers known as myelodysplastic syndromes.

Although the panel’s vote is not a final decision, the FDA traditionally
abides by the recommendation of its expert panels.

Celgene said that the FDA is scheduled to formally rule on whether to
approve Revlimid by Oct. 7. The company already markets a version of thalidomide called Thalomid, for the treatment of leprosy, and Alkeran, a treatment for the cancer multiple myeloma.

1 Comment

  1. tomferguson

    Hi, Beth,

    I’m a 14-year myeloma survivor, a senior research fellow with the Pew Internet & American Life Project, a health services researcher studying the experiences of e-patients like yourself, and an advisor to the Robert Wood Johnson Foundation (RWJF) on grantmaking and research recommendations in the emerging world of e-patients.

    I’ve been looking at e-patient weblogs & naturally started with myeloma… I like your blog & was wondering if you’d be willing to share how it has helped you and how it has allowed you to help others. I’m looking for quotes I can use in the White Paper I’m currently writing for RWJF. It will also be sent to 100s of other foundations that fund healthcare reaearch–and to many of the principal figures in the current efforts to reform healthcare via effective use if IT.

    You can find more on me on my old web sites: http://www.fergusonrteport.com and doctom.com. After the white paper is finished, I will be starting a new weblog at e-patients.net.

    I’m also a physician, though not a clinician, but have a great myeloma doc at Little Rock and lead a local MM support group here in Austin. So would be happy to help with any myeloma-related questions.

    Warm wishes,

    ???Tom Ferguson


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