Celgene Submits Pomalidomide For FDA Approval
Published: Apr 26, 2012 7:18 am
Celgene Corporation announced this morning that it has completed submission of its application to the U.S. Food and Drug Administration (FDA) for the approval of pomalidomide as a treatment for relapsed and refractory multiple myeloma.
If the FDA approves pomalidomide based on this application, Celgene could begin marketing pomalidomide in the United States as early as this fall.
Pomalidomide (Pomalyst), which belongs to the same class of drugs as thalidomide (Thalomid) and Revlimid (lenalidomide), is being developed by Celgene (NASDAQ: CELG) for the treatment of multiple myeloma and myelofibrosis.
Results from the latest clinical trials involving pomalidomide in relapsed/refractory multiple myeloma were presented at the American Society of Hematology meeting last December (see related Beacon news). Physicians as well as industry analysts have responded positively to the drug’s performance, particularly among patients previously treated with both Revlimid and Velcade (bortezomib).
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Under the FDA’s standard review process, the agency must decide whether to approve a drug within 10 months of the time the drug is submitted for review. However, the FDA can grant priority review to drugs that offer significant advances in treatment, particularly for diseases in which there are inadequate treatment options. If the FDA grants pomalidomide priority review, the agency would need to complete its review of the drug within six months.
Thus, if the FDA approves pomalidomide based on the application Celgene recently submitted, the drug could be available for use in the U.S. by the last quarter of 2012 or early 2013.
Celgene plans to submit a similar application to the European Medicines Agency by the end of June.
Along with carfilzomib (Kyprolis) – which works similarly to Velcade – pomalidomide is considered one of the most promising new myeloma treatments that could be approved by the FDA in the next few years.
For more information, see the Celgene press release.
- Celgene Updates Timeline For Pomalidomide Approval In The U.S. And Europe
- Pomalidomide Gets Standard FDA Review And Application For European Approval
- FDA Sets Date For Pomalidomide Advisory Committee Meeting
- Pomalidomide FDA Advisory Committee Meeting Canceled
- Pomalidomide (Pomalyst) - The Waiting Game