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Celgene Applies For Approval Of Revlimid As Maintenance Therapy Drug In Europe

Home/Celgene Applies For Approval Of Revlimid As Maintenance Therapy Drug In Europe

Celgene Applies For Approval Of Revlimid As Maintenance Therapy Drug In Europe

Here is part of the latest press release from Celgene, makers of the oral multiple myeloma chemotherapy drug, Revlimid:

BOUDRY, Switzerland, January 4, 2011 – Celgene International Sàrl (NASDAQ: CELG) announced regulatory submissions for its blood cancer therapy REVLIMID today.
The company submitted a Marketing Authorisation Application (MAA) for the approval of REVLIMID (lenalidomide) for maintenance treatment of newly diagnosed multiple myeloma patients who have not progressed following initial treatment with melphalan, prednisone and REVLIMID, or following autologous stem cell transplantation. The application was submitted with the European Medicines Agency (EMA) on December 31, 2010.

The MAA will be reviewed by the Committee for Medicinal Products for Human Use (CHMP). Review of each application will be conducted by the EMA under the centralised licensing procedure, which, when finalised, provides one marketing authorisation in all 27 member states of the European Union.

The application was based on the results of MM-015, an international, randomised pivotal phase III study. The submission is also supported by two additional PHASE III studies comparing continuous REVLIMID therapy following autologous stem cell transplant versus placebo. Unprecedented results from these phase III studies were presented at the American Society of Hematology Annual Meeting in December 2010.
Did you know that Revlimid is still not FDA approved for use in newly diagnosed patients in the United States and most of Europe?  It also isn’t approved for use as a maintenance drug. 
No, it is only approved for use in relapsed multiple myeloma.  But oncologists prescribe it “off label” for other uses.  Fortunately, most insurance companies and Medicare now pay for Revlimid for new patients or for maintenance chemotherapy.
It is good to know Celgene is continuing to work toward formal approval of Revlimid for a variety of applications.  That will help keep insurance companies from denying coverage to patients arbitrarily.
Feel good and keep smiling!  Pat