Drug news
FDA Advisory Committee does not recommend LBH 589 for treatment of Multiple Myeloma - Novartis
Novartis has announced that the FDA Oncologic Drugs Advisory Committee (ODAC) did not recommend the investigational compound LBH 589 (panobinostat), a pan-deacetylase (pan-DAC) inhibitor, for patients with previously treated Multiple Myeloma when used in combination with bortezomib[and dexamethasone. Data presented at the meeting included two clinical studies evaluating LBH 589 in combination with bortezomib and dexamethasone for patients with relapsed or relapsed and refractory Mutiple Myeloma: a Phase III randomized, double-blind, placebo-controlled, multicenter global registration trial called PANORAMA-1 (PANobinostat ORAl in Multiple MyelomA) and a Phase II US multicenter, single-arm, open-label study called PANORAMA-2.