Basel, Switzerland (Press Release) - Novartis announced today that the US Food and Drug Admin­istra­tion (FDA) has extended their priority review period by up to three months for the new drug appli­ca­tion (NDA) of LBH589 (panobinostat) in com­bi­na­tion with bor­tez­o­mib* and dexa­meth­a­sone for patients with pre­vi­ously treated multiple myeloma.

 …

Panobinostat had an important appointment this morning with a group of on­col­o­gists.

The appointment did not go so well.

The Oncologic Drugs Advisory Committee (ODAC) of the U.S. Food and Drug Administration (FDA) conducted a four-hour review of panobinostat (Farydak) earlier today.

At the end of the meeting, members of the committee were asked to vote whether they felt the benefits of panobinostat as a potential treatment for relapsed myeloma outweighed its risks.

Five committee members voted "no." Only two members voted "yes."

The advisory committee's vote is a serious …

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 …

As reported earlier today by The Beacon, the U.S. Food & Drug Admin­is­tra­tion (FDA) this morning released key documents related to the agen­cy’s review of pano­bino­stat as a potential new treatment for multiple myeloma.

The documents consist of briefing reports, agendas, and other sup­port­ing material for the meeting of the FDA’s Oncologic Drugs Advisory Com­mit­tee (ODAC) this coming Thursday. The morning session of that meet­ing will be devoted to a review of pano­bino­stat (Farydak), which is being developed by the Swiss pharmaceutical company Novartis (NYSE:NVS).

Among the documents released this morning, two …

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 …

It seems that panobinostat’s review by the U.S. Food and Drug Ad­min­is­tra­tion (FDA) may be on track after all.

A spokeswoman for Novartis (NYSE:NVS), the Swiss pharmaceutical company that is developing panobinostat as a potential new myeloma therapy, has told The Beacon that, contrary to a Beacon report published yesterday, there has not been a delay in the FDA’s review of the drug’s marketing application.

With panobinostat’s review proceeding according to the expected time­table, there need not be concern that the FDA has uncovered un­ex­pected issues with the drug. …

The U.S. Food and Drug Administration (FDA) is giving itself an extra two to three months to decide whether to approve panobinostat as a new treatment for mul­ti­ple myeloma.

The FDA had been expected to reach a decision on the panobinostat new drug application by last Tuesday.  Now, however, a decision is unlikely to occur until the end of November or sometime in December.

The Swiss pharmaceutical company Novartis (NYSE:NVS) filed an ap­pli­ca­tion with the FDA in March to have panobinostat, in combination with Velcade (bortezomib) and