Novartis Submits Panobinostat For FDA Approval As New Treatment For Multiple Myeloma, Gains Priority Review
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.
- Panobinostat FDA Review On Schedule, Novartis Says
- Beacon Breaking News – Carfilzomib To Get Standard, Not Priority, FDA Review
- Beacon Breaking News – FDA Accepts Carfilzomib New Drug Application
- FDA Delays Decision On Panobinostat New Drug Application
- FDA Sets Date For Carfilzomib Advisory Committee Meeting