The Oncologic Drugs Advisory Committee (ODAC) of the U.S. Food and Drug Administration (FDA) has voted 11 to zero with one abstention in favor of car­filz­o­mib's bid to be approved as a new treat­ment for multiple myeloma.

Specifically, the majority of the committee voted that the risk-benefit assess­ment for carfilzomib ^[1] (Kyprolis ^[2]) is favorable for the treat­ment of patients with re­lapsed and refractory multiple myeloma who have received at least two prior lines of ther­apy.

Today's vote by the FDA committee went much better for car­filz­o­mib than had been expected.   A recent survey of major Wall Street investors, for example, showed a significant majority expecting a negative vote by the FDA panel (see related Beacon ^[3] news).

In addi­tion, an FDA briefing document for today's meeting that was released earlier this week voiced strongly worded concerns ^[4] about car­filz­o­mib's safety.  Publication of the FDA report caused the stock of Onyx Pharmaceuticals (NASDAQ:ONXX), the com­pany developing car­filz­o­mib, to drop more than 4 per­cent.

During today's meeting, however, the FDA staff presentation regarding car­filz­o­mib's efficacy and safety was considerably less critical of car­filz­o­mib.  In its discussion of potentially life-threatening side effects of the drug, for example, the FDA presentation noted that they occurred "with a low frequency" during relevant clinical trials.

In contrast, the presentations by Onyx employees and myeloma opinion leaders presenting on car­filz­o­mib's behalf laid out a strong case for both the efficacy and safety of the drug.

As a result, the momentum was in car­filz­o­mib's favor for most of today's meeting.  (See the Beacon's live coverage ^[5] of today's meeting for details of all the presentations and question-and-answer sessions during the car­filz­o­mib review.)

Onyx completed an application to the FDA last September to have car­filz­o­mib as a new myeloma treat­ment (see related Beacon ^[6] news).

The FDA will consider the advisory committee’s vote as well as comments made during today’s meeting when deciding whether to approve car­filz­o­mib's new drug application.

Although the FDA is not legally bound to follow its advisory committees’ recommendations regarding new drug applications, it usually does.

The FDA is required to make a decision about car­filz­o­mib’s application by July 27.  It also has the option, however, of extending this deadline if it feels it needs addi­tional time to complete its review.

For more in­­for­ma­tion about the FDA’s ongoing review of the car­filz­o­mib application, see the latest Beacon ^[1] news about car­filz­o­mib.