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FDA postpones approval of Revlimid® for MDS
But Celgene says filing for myeloma remains on track
The IMF is pleased to report that, according to Celgene, plans to seek FDA approval of Revlimid® to treat multiple myeloma remain unchanged. Celgene’s announcement was in response to the FDA’s decision to extend the time it will need to approve Revlimid for the blood condition MDS - approval that had been expected later this week. A Celgene statement today said the company remains on track for “a November submission of our Revlimid application for treatment of previously-treated patients with relapsed or refractory multiple myeloma.” That would put possible approval early in 2006.

Today’s delay is to give the FDA time to assess Celgene’s risk-management program called RevAssist® - a program analogous to the S.T.E.P.S®. program used for Thalomid®, but tailored specifically to guide appropriate distribution of Revlimid. We too want to see all drugs used safely and effectively.

Last week an ongoing trial of Revlimid in myeloma was suspended because of concerns over clotting. The investigators say this clotting can be managed effectively just by taking by aspirin regularly, and according to Celgene this did not enter into the FDA’s decision today. The trial is expected to resume in just a few week’s time after the protocol is amended to include daily doses of aspirin.

Based on the efficacy demonstrated by Revlimid in two myeloma Phase III clinical trials, we are eager to see Revlimid added to our arsenal against this disease. We are reassured by Celgene’s statement that filing for myeloma approval remains on track and we will continue to monitor these developments closely.

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