Good morning everyone,
Just a quick FYI for everyone ... The FDA has delayed its decision regarding panobinostat's new drug application.
A decision was due by the end of this month. However, in a press release this morning, it was announced that the FDA has extended its review of the drug by three months to allow it more time to reach a decision on the application.
You can view the press release here:
"Novartis Announces Extension To FDA Review Period For Multiple Myeloma Investigational Compound LBH589," Novartis press release, November 25, 2014.
Novartis Announces Extension To FDA Review Period For Multiple Myeloma Investigational Compound LBH589
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.
The NDA for LBH589 was submitted to the FDA in March 2014. In May 2014, the FDA granted priority review status to LBH589, reducing the standard 12-month review period to eight months. The extension to the LBH589 NDA review period follows an FDA Oncologic Drugs Advisory Committee (ODAC) meeting earlier this month.
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You can find all the Beacon's news articles about panobinostat, including coverage of the recent FDA advisory committee meeting related to the drug, at the Beacon's panobinostat topic page,
https://myelomabeacon.org/tag/panobinostat/
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