FDA Extends Priority Review of Novartis DrugBy
Novartis reports that the US Food and Drug Administration (FDA) has extended its priority review period by up to three months for the company’s 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 in November 2014.
LBH589 is a potent pan-deacetylase (pan-DAC) inhibitor that if approved could be a first-in-class treatment for patients with relapsed or relapsed and refractory multiple myeloma. As an epigenetic regulator, LBH589 may help restore cell programming in multiple myeloma.