ARTICLE | Clinical News

Panobinostat regulatory update

October 13, 2014 7:00 AM UTC

FDA's Oncologic Drugs Advisory Committee will meet on Nov. 6 to discuss an NDA from Novartis for panobinostat, which is under Priority Review to treat multiple myeloma (MM) in combination with Velcade bortezomib and dexamethasone in patients who have received >=1 prior therapy. Novartis submitted the application in March; FDA granted it Priority Review in May. In 2Q14, Novartis submitted an MAA to EMA for panobinostat to treat MM. ...