US FDA pushes back decision date for Novartis’ panobinostat

The US Food and Drug Administration has extended its priority review period by up to three months for Swiss pharma giant Novartis’ (NOVN: VX) New Drug Application of LBH589 (panobinostat; proposed trade name Farydak) in combination with bortezomib and dexamethasone for patients with previously treated multiple myeloma.

The NDA for panobinostat was submitted to the FDA in March 2014. In May 2014, the FDA granted priority review status to panobinostat, reducing the standard 12-month review period to eight months. The extension to the panobinostat NDA review period follows a negative FDA Oncologic Drugs Advisory Committee (ODAC) recommendation earlier this month.

"We are committed to working with the FDA as they continue to review the LBH589 NDA," said Alessandro Riva, global head of oncology development and medical affairs, at Novartis Oncology, adding: "Multiple myeloma remains an incurable cancer where patients who have relapsed or become resistant to available therapies need new treatment options."