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Pomalidomide (Pomalyst) - The Waiting Game

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Published: Feb 8, 2013 10:45 am

The "what will the FDA decide about pomalidomide" waiting game is reaching its final hours, and the drama is peaking.

Celgene (CELG:NASDAQ), the company that has been developing poma­lido­mide, asked the U.S. Food and Drug Administration (FDA) last April to approve the drug for the treatment of relapsed and refractory myeloma.

Based on the date the company filed its new drug application with the FDA, the regulator is required to make a decision on the application by this coming Sunday, February 10.

Financial analysts are expecting a positive decision by the agency.  They estimate the likelihood of FDA approval as 80 to 90 percent, according to a small survey conducted this week by the Bloomberg news service.

If, as anticipated, the FDA decides to approve pomalidomide, it is likely to issue its decision by the close of business today.  The FDA rarely makes such decisions on weekends.

Thus, news of an approval could come out later today or early tomorrow.  The Beacon, of course, will announce the news as soon as it is made public.

Celgene has proposed "Pomalyst" as the brand name that it will use when it markets pomalidomide.

The FDA also could choose to delay a decision on pomalidomide's new drug application if it feels it needs additional information to reach a decision.  The Sunday deadline is not, as commonly thought, a deadline for a yes or no decision.  A decision to delay the final decision is also possible.

One reason, however, that analysts doubt the FDA will take this step is that the agency thus far has decided not to hold a public meeting with outside medical experts to discuss the pomalidomide new drug application.  A meeting of the Oncologic Drugs Advisory Committee (ODAC), as the relevant group of experts is called, is usually arranged when the FDA has questions or is otherwise uncertain about aspects of a new drug application.  Such a meeting was held, for example, in the case of Kyprolis (carfilzomib), before it was finally approved by the FDA last July.

The FDA originally scheduled a meeting of the ODAC last fall to discuss pomalidomide's new drug application.  However, the FDA subsequently decided to cancel that meeting (see related Beacon news).

Since then, the regulator has not scheduled a new ODAC meeting to review pomalidomide's approval application.

Given this sequence of events, and given the FDA approval of Kyprolis based on data considered to be similar to the data Celgene has submitted to the FDA on behalf of pomalidomide, the expectation is that the agency will, in fact, approve pomalidomide.

A final possible outcome of the current waiting game is that the FDA could announce before this Sunday that it has decided not to approve pomalidomide.  However, that outcome is believed to be highly unlikely.

Celgene also has submitted a marketing authorization application for pomalidomide to the European Medicines Agency.  The application was submitted last June (see related Beacon news).  In recent discussions with financial analysts, it has said that it anticipates a decision on that application by the second half of this year.

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