The U.S. Food and Drug Administration this morning released important in­for­ma­tion related to its Oncologic Drugs Advisory Committee meeting scheduled for this Thursday, when the committee will review data related to the application by Novartis (NYSE:NVS) to have pano­bino­stat (Farydak) approved as a new treatment for multiple myeloma.

In addition to a draft agenda and draft committee roster, the Food and Drug Administration (FDA) released briefing information for the com­mit­tee members and a question about the risk/benefit profile of pano­bino­stat that the advisory committee will discuss and vote on at the meeting.

The FDA briefing document and question for the committee can be useful in gauging internal FDA sentiment in regard to pano­bino­stat's new drug application.

Earlier this year, Novartis submitted an application to the FDA to have pano­bino­stat approved as a new treat­ment for multiple myeloma (see related Beacon news).

To assist it with its review of the Novartis application, the FDA has scheduled Thursday’s meeting of the Oncologic Drugs Advisory Committee (ODAC).  The ODAC is the advisory committee that advises the FDA regarding cancer drugs.

The FDA is expected to make a decision about pano­bino­stat’s application by the end of this month.

Draft Question

Novartis submitted the pano­bino­stat new drug application based primarily on results of the Phase 3 clinical trial known as PANORAMA-1. Patients in the trial were randomly assigned to one of two treatment regimens: pano­bino­stat, Velcade (bortezomib), and dexa­meth­a­sone (Decadron); or a placebo (sugar pill) combined with Velcade and dexamethasone.

The discussion at this week's ODAC meeting will focus on the results of the PANORAMA-1 trial, and the documents prepared for the meeting reflect that focus.

One of the key documents prepared for the meeting and released by the FDA this morning is a draft of the question the advisory committee will vote on at the end of this Thursday's morning session.

The question is: "Given this benefit:risk profile of the addition of pano­bino­stat to bortezomib and dexa­metha­sone, does the benefit outweigh the risks for patients with relapsed multiple myeloma?"

The sheet listing the question for the advisory committee also includes a bullet-point summary of the FDA staff's analysis of the PANORAMA-1 trial results.

Briefing Information

Two sets of briefing information for Thursday morning's pano­bino­stat session were released this morning.

The first is an extensive FDA staff review of the pano­bino­stat drug application (main document).  Besides providing background information about multiple myeloma, the document describes the PANORAMA-1 trial design and summarizes the efficacy and safety data from the trial.

The FDA briefing information along with the wording of the question the FDA will ask the advisory committee to vote on are important.  They provide insight into which way the FDA is leaning in regard to whether or not to approve pano­bino­stat.

In addition to the internal FDA review of pano­bino­stat's new drug application, the FDA this morning also released a briefing document prepared by Novartis, the company developing pano­bino­stat.

Draft Agenda

The advisory committee will be discussing two drugs during Thursday's meeting.  Panobinostat will be discussed during the morning session.

After opening remarks and introduction of the committee, there will be four presentations organized by Novartis.  Two of the four presentations will be by employees from Novartis, one will be by Dr. Keith Stewart of the Mayo Clinic, and one will be by Dr. Paul Richardson of the Dana-Farber Cancer Institute. The pre­sen­ta­tions will brief the ODAC on multiple myeloma and likely explain why approving pano­bino­stat will improve the care available to multiple myeloma patients.

The Novartis-organized presentations will then be followed by presentations from two FDA staff members. These presentations will cover some of the same ground covered by in the Novartis presentations, but will likely focus on differences of interpretation between the FDA and Novartis in regard to the PANORAMA-1 trial results.

After the committee is given a chance to ask any questions they may have about the presentations from Novartis and the FDA staff, the public will be given the opportunity to address the advisory committee. This is a time when patients, advocacy organizations, or others with an interest in whether the drug gets approved can present their comments.

The committee members will then discuss the question the FDA has asked them to vote on.  The meeting will then conclude with the committee’s vote.

The committee's vote can be expected to play a role in the FDA's decision regarding pano­bino­stat's new drug application.  However, the FDA is not legally bound to make decisions on new drug applications that are in agreement with the advice it receives from its advisory committees.

Additional Details And Assessment Of The FDA Documents

This news update provides an initial overview and summary of the documents released by the FDA this morning.  The Beacon will be analyzing the documents in more detail as the morning progresses, and will publish a follow-up article as soon as that analysis is completed.