The Oncologic Drugs Advisory Committee of the U.S. Food and Drug Adminis­tra­tion will convene this morning to review pano­bino­stat, and The Myeloma Beacon will provide live coverage of the meeting.

Beacon staff members will post frequent updates at the webpage for this article as the meeting proceeds. Coverage will begin at the start of the meeting at 8 a.m. Eastern Time, which is when the review of pano­bino­stat (Farydak) is scheduled to begin.

The Swiss pharmaceutical company Novartis (NYSE:NVS) submitted an application to the Food and Drug Administration (FDA) this March to have pano­bino­stat approved for the treatment of relapsed multiple myeloma (see related Beacon news).

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

During today’s meeting, the Oncologic Drugs Advisory Committee (ODAC), which advises the FDA regarding cancer drugs, will review briefing information that the FDA released for the committee members on Tuesday (see related Beacon news).

Representatives from Novartis, including scientific advisers to the company, also will be given an opportunity to present  information during the meeting, as will members of the public.

At the end of the meeting, members of the ODAC will discuss the material they have been presented and vote whether they believe the risk/benefit profile of pano­bino­stat is favorable.

The ODAC vote will generally be interpreted as a recommendation for, or against, the FDA approving pano­bino­stat. The FDA is not legally required to follow the recommendations of its advisory committees; however, it usually does.

Please check back at 8 a.m. Eastern Time today when the Beacon’s live coverage of the advisory committee meeting will begin right here.

Our updates from the meeting will appear directly below and you will receive notifications here when new updates are ready. Just click on the notification when it appears to display the new notifications.

Notifications may not appear on older version of Internet Explorer (version 8 or older). Also, to reduce the load on the Beacon's webserver, commenting on this article will be turned off during the meeting.