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.

"We are committed to working with the FDA as they continue to review the LBH589 NDA," said Alessandro Riva, MD, Global Head of Oncology Development and Medical Affairs, Novartis Oncology. "Multiple myeloma remains an incurable cancer where patients who have relapsed or become resistant to available therapies need new treatment options."

For more details, go to: http://www.novartis.com/newsroom/media-releases/en/2014/1873858.shtml