Celgene announced this morning that it plans to submit an application for the approval of pomalidomide for relapsed and refractory multiple myeloma to the U.S. Food and Drug Administration (FDA) during the first quarter of 2012.

In addition, the company said that it plans to submit a similar application to the European Medicines Agency (EMA) during the first half of this year.

The updated submission timeline means that pomalidomide could be approved for use in the United States and in Europe by the end of this year.

Celgene's announcement was made in a company earnings report.

Pomalidomide ^[1] (Pomalyst ^[2]), which belongs to the same class of drugs as thalidomide ^[3] (Thalomid) and Revlimid ^[4] (lena­lidomide), is being developed by Celgene (NASDAQ: CELG) for the treatment of multiple myeloma and myelofibrosis.

Results from the latest clinical trials involving pomalidomide were presented at the American Society of Hematology meeting last month (see related Beacon ^[6] news).  Physicians and industry analysts have responded positively to the drug’s performance, particularly among patients previously treated with both Revlimid and Velcade ^[7] (bortezomib).

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 submits this quarter, the drug could be available for use in the U.S. by the last quarter of 2012 or early 2013.

In Europe, the EMA must review drug applications within 210 days of submission.  If, however, a drug is granted an accelerated assessment due to therapeutic innovation or because it is of significant interest to the public health, the EMA must review the application within 150 days.

These timelines mean that, if the EMA approves pomalidomide based on the application Celgene submits during the first half of this year, the drug could be available for use in Europe by the end of 2012 or the first quarter of 2013.

An EMA approval of pomalidomide would allow the drug to be marketed in all 27 countries of the European Union and in Norway, Iceland, and Liechtenstein.

Along with carfilzomib ^[8] (Kyprolis ^[9]) – 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 the full earnings report, see the Celgene ^[10] website.