Pomalidomide FDA Advisory Committee Meeting Canceled
Published: Oct 3, 2012 6:58 pm
The U.S. Food and Drug Administration (FDA) has canceled the November advisory committee meeting during which Celgene’s application to have pomalidomide (Pomalyst) approved as a new multiple myeloma treatment was scheduled to be reviewed.
The meeting of the advisory committee — formally known as the Oncologic Drugs Advisory Committee (ODAC) — was placed on the FDA schedule just last month (see related Beacon news).
The cancellation of the ODAC meeting does not necessarily mean there has been any change in either the FDA’s overall schedule for reviewing pomalidomide’s new drug application or the likelihood of the agency approving the drug.
The timeline for the drug’s review was addressed directly in the press release Celgene (NASDAQ: CELG) issued today about the cancellation of the meeting.
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In the press release, Celgene said that the FDA has informed the company that the review of pomalidomide’s application “is continuing.” Celgene further indicated that the FDA still expects to reach a decision about pomalidomide’s application by February 10, 2013, the date by which the FDA is legally required to issue a decision on the application.
The FDA typically schedules ODAC meetings to give members of the advisory committee, other experts, and company representatives a chance to advise the agency about issues related to FDA applications involving cancer treatments.
In June of this year, for example, the FDA held an ODAC meeting to review the new drug application for Kyprolis (carfilzomib) (see the Beacon’s detailed coverage of the meeting). The FDA then went on in July to approve Kyprolis as a new treatment for relapsed/refractory multiple myeloma (see related Beacon news article).
The FDA is not required, however, to hold an ODAC meeting before it reaches a decision in regard to a new drug application. The agency can opt to make a decision without holding an advisory committee meeting if the regulator feels it already has sufficient information about the drug it is reviewing.
Thus, there are at least two possible interpretations to today’s announcement that pomalidomide’s November ODAC meeting has been canceled.
One interpretation is that the FDA simply wants more time to prepare for an ODAC meeting, and it will schedule a new ODAC meeting to review pomalidomide either later this year or early next year.
An alternative interpretation is that the FDA believes it already has enough information to reach a decision about pomalidomide’s application, and that it is prepared to make a decision without holding an ODAC meeting.
Several investment analysts with whom The Beacon consulted in regard to today’s development believe the second interpretation may be the more likely of the two. They also believe that, if this is the case, the FDA is likely to be leaning toward approving pomalidomide.
For example, Wells Fargo investment analyst Brian Abrahams, writing in a report earlier today about the cancellation of the ODAC meeting, said that, although “expectations are already high for pomalidomide approval, the cancellation of the FDA panel could further increase the likelihood.”
Financial markets today interpreted the pomalidomide news as, at worst, a neutral development. Celgene’s stock was up 0.7% today, slightly better than the overall market.
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 news).
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.
Until the FDA reaches a decision regarding pomalidomide’s application, the drug is available through Celgene’s expanded access program, called PEXIUS, for relapsed and refractory myeloma patients in the U.S. who do not have any other treatment options.
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 cancellation of the November pomalidomide FDA advisory committee meeting, see the Celgene press release.