Celgene announced this morning that the U.S. Food and Drug Administration has set a date for an advisory committee meeting to review the company’s application for approval of pomalidomide.

Celgene (NASDAQ: CELG) has applied to the Food and Drug Administration (FDA) to have pomalidomide ^[1] (Pomalyst ^[2]) approved, in combination with dexamethasone ^[3](Decadron), for the treatment of patients with relapsed and refractory multiple myeloma that has progressed after at least two prior therapies.

The Oncologic Drugs Advisory Committee (ODAC), which advises the FDA regarding the potential approval of new cancer drugs, will meet on November 8 to review the pomalidomide application.

The FDA is not legally bound to follow the advice of its advisory committees regarding new drug applications, but it usually does.  The agency is required to make a decision about pomalidomide’s application by February 10.

Until the FDA reaches a decision regarding pomalidomide’s application, the drug is available through Celgene’s expanded access program, called PEXIUS ^[5], for relapsed and refractory myeloma patients in the U.S. who do not have any other treatment options.

Pomalidomide belongs to the same class of drugs as thalidomide ^[6] (Thalomid) and Revlimid ^[7] (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 for myelo­fibrosis, a disorder of the bone marrow in which the marrow is replaced by scar (fibrous) tissue.

Celgene completed the FDA submission of pomalidomide’s new drug application in April (see related Beacon ^[8] news).

In June, the FDA granted “standard review designation” to the application (see related Beacon ^[9] news).

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 did not come as a surprise, given that Kyprolis ^[10] (carfilzomib), another drug that the FDA recently approved for multiple myeloma, also was granted standard review (see related Beacon ^[11] news).

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.

If the FDA had granted priority review to pomalidomide, the agency would have needed to complete its review within six months.  The FDA can grant priority review to drugs that offer significant advances in treatment, particularly for diseases in which there are inadequate treatment options.

Results from the latest clinical trials involving pomalidomide in relapsed/refractory multiple myeloma were presented at the American Society of Clinical Oncology annual meeting this summer (see related Beacon ^[12] 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 ^[13] (bortezomib).

If the FDA makes a positive decision regarding pomalidomide’s new drug application, Celgene will be allowed to start marketing the drug in the United States 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.

If pomalidomide is approved by February, it will be the second new myeloma drug to be approved by the FDA within a year’s time.  In July, the agency approved Kyprolis for the treatment of people with multiple myeloma who have received at least two prior therapies (see related Beacon ^[14] news).

Celgene also submitted a marketing authorization application for pomalidomide to the European Medicines Agency this past June,  meaning the drug could be approved for use in Europe by the middle of 2013.

For more information regarding the pomalidomide FDA advisory meeting in November, see the Celgene ^[15] press release.