Celgene Corporation announced this morning that the U.S. Food and Drug Administration (FDA) has granted “standard review designation” to the company’s new drug application for pomalidomide.

This designation means that the FDA expects to make a decision by February 10, 2013, on Celgene’s application to market pomalidomide (Pomalyst) in the United States.

Celgene (NASDAQ:CELG) also confirmed this morning that a marketing authorization application for pomalidomide has been submitted to the European Medicines Agency (EMA), meaning pomalidomide could be approved for use in Europe by the end of 2012 or early 2013.

Pomalidomide belongs to the same class of drugs as thalidomide (Thalomid) and Revlimid (lenalido­mide) -- two drugs that Celgene already markets as myeloma treatments in the U.S. and internationally. Celgene is developing pomalidomide as a potential new treatment for multiple myeloma and myelo­fibrosis.

Although Celgene may have hoped that pomalidomide would be granted a so-called "priority review" by the FDA, the agency's decision to do a standard review instead does not come as a surprise.  Carfilzomib, another drug being developed for multiple myeloma, also was granted standard review by the FDA this past December (see related Beacon news).

The target FDA review time for applications granted a priority review is four months shorter than for drugs with a standard review designation.

If the FDA makes a positive decision regarding pomalidomide’s new drug application by next February, Celgene will be allowed to start marketing the drug in the United States to be used in combination with dexamethasone (Decadron) as a new treatment for relapsed and refractory myeloma.

A negative decision by the FDA would delay the launch of pomalidomide until Celgene is able to address any questions or concerns raised by the FDA.

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 just submitted, 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.

Pomalidomide’s applications are based on data from the Phase 2 “MM-002” study of pomalidomide plus dexamethasone in relapsed and refractory myeloma patients.  Results from this study were presented at the American Society of Clinical Oncology meeting in June (see related Beacon news).

The Phase 3 “MM-003” study comparing pomalidomide plus low-dose dexamethasone to only high-dose dexamethasone, also in heavily pretreated myeloma patients, is expected to complete enrollment in July.  Results are expected by the end of the year.

Pomalidomide and carfilzomib (Kyprolis) – which works similarly to Velcade (bortezomib) – are the only drugs currently under review by the FDA for potential approval as new treatments for myeloma.

An advisory committee to the FDA cast a strong positive vote yesterday in favor of approving carfilzomib’s application to be approved for the treatment of multiple myeloma (see related Beacon news).

The FDA will make a decision about carfilzomib’s application by July 27, but it has the option of requesting more data and extending this deadline if it feels it needs additional time or information to complete its review.