Carfilzomib Earns Strong Positive Vote From FDA Advisory Committee
Published: Jun 20, 2012 4:21 pm
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 (Kyprolis) 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 news).
In addition, an FDA briefing document for today’s meeting that was released earlier this week voiced strongly worded concerns 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 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 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 news about carfilzomib.
- FDA Releases Key Documents Related To Carfilzomib Advisory Committee Meeting
- FDA Sets Date For Carfilzomib Advisory Committee Meeting
- Carfilzomib To Face Critical FDA Advisory Committee Meeting Next Week
- ‘Kyprolis’ Is Proposed Brand Name For Carfilzomib
- Onyx: No Real News To Report About Carfilzomib And The FDA