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Novartis Submits Panobinostat For FDA Approval As New Treatment For Multiple Myeloma, Gains Priority Review

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Published: Jun 2, 2014 12:21 pm; Updated: Jun 2, 2014 3:05 pm

Panobinostat could be the next potential myeloma therapy approved by the U.S. Food and Drug Administration (FDA).

Moreover, an approval decision related to the drug’s potential marketing in the United States could be made by this fall.

In a surprisingly indirect manner, Novartis, the Swiss pharmaceutical com­pany that is developing panobinostat (LBH589), announced this morn­ing that it has filed an application to have panobinostat approved as a new drug by the FDA.

The announcement was indirect in the sense that Novartis did not actually say it has filed an application for FDA approval of panobinostat.

Instead, the company said that the FDA last month granted panobinostat “priority review.”

The FDA, however, only grants a drug priority review – instead of standard review – once an application has been submitted for the drug to be reviewed and potentially approved by the FDA.  A Novartis spokesperson also confirmed to The Beacon that panobinostat is currently under review by the FDA, and that the new drug application was filed in March.

Thus, the key news in the Novartis announcement – from the perspective of the multiple myeloma community – is that the company has filed the drug with the FDA for review and potential approval.

Of course, the news that panobinostat has been granted priority review is also an important de­vel­op­ment. The target FDA review time for applications granted a priority review is six months, or four months shorter than for drugs with a standard review designation.

Given that panobinostat new drug application was filed in March, an FDA decision on the application can be expected by September (six months from March).

Although the Novartis announcement this morning did not provide many details about its application for FDA approval of pano­bino­stat, a Novartis spokesperson confirmed to The Beacon that the application is for approval as a new myeloma treat­ment.  In addition, the application is based on the data for pano­bino­stat presented at this morning’s session of myeloma-related pre­senta­tions at the 2014 American Society of Clinical Oncology (ASCO) meeting.

Those data are from the Phase 3 clinical trial known as PANORAMA-1. The trial tested panobinostat in com­bi­na­tion with Velcade (bortezomib) and dexamethasone (Decadron) in relapsed/refractory multiple myeloma patients who have failed at least one prior treatment.  The presentation of the PANORAMA-1 results was discussed in the Beacon’s ASCO 2014 myeloma preview, and further details will be provided in a future Beacon ASCO update.

The Novartis announcement also did not provide any specific updates on filings for the approval of panobinostat in other parts of the world, saying only that “additional global regulatory submissions are underway” — which, it should be noted, could mean that some filings outside the U.S. already have been made.

Estimates provided to The Beacon by Evaluate Ltd., a market intelligence and analysis firm, suggest that an application for the drug’s approval in Europe could be filed some­time this year.  This would result in an approval decision in Europe by the end of next year (2015).

Panobinostat is an oral drug that belongs to a class of drugs called histone deacetylase (HDAC) inhibitors, which work by increasing the production of proteins that slow cell division and cause cell death.

Preclinical studies have shown that panobinostat in combination with Velcade more effectively kills myeloma cells than either drug alone.

Another HDAC inhibitor, Zolinza (vorinostat), has also been studied as a potential new treatment for multiple myeloma.  However, it was recently shown to have had only a small impact on progression-free survival when used in combination with Velcade in relapsed/refractory myeloma patients (see related Beacon news).

For more information about the panobinostat trial results presented this morning and panobinostat’s regu­la­tory status, see the Novartis press release.

Photo by gtrwndr87 on Flickr – some rights reserved.
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2 Comments »

  • R said:

    Here is the Internet price $$…..if you are a lab rat or mouse:

    LBH589 10mg
    $50.00

    LBH589 50mg
    $180.00

    LBH589 100mg
    $300.00

    LBH589 200mg
    $450.00

    Not approved in Humans, as yet.

    Price is For Each Pill…

  • Nancy Shamanna said:

    Thanks Beacon Staff for this comprehensive article. I do find a lot of my info regarding new drugs and studies from you, and I really appreciate that!

    Nice that Panobinostat is being considered after Phase 3 trials, for a priority review. Phase 3 results are better than Phase 2 for gaining approval in other countries such as Canada. I noticed that the clinical trial, PANORAMA 1, was conducted in 212 different sites, including several here, in Nova Scotia, Ontario and Quebec. That bodes well for the concept of Novartis applying to Health Canada for approval of the drug. Drug advocacy is ongoing in all countries of course for new treatments for myeloma.