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FDA extends review of Novartis' panobinostat

November 26, 2014 1:49 AM UTC

FDA will extend by up to three months its review of an NDA for panobinostat from Novartis AG (NYSE:NVS; SIX:NOVN). The agency granted Priority Review in May to the oral pan-deacetylase (DAC) inhibitor in combination with Velcade bortezomib and dexamethasone to treat multiple myeloma (MM).

On Nov. 5, FDA's Oncologic Drugs Advisory Committee (ODAC) voted 5-2 that panobinostat's 3.9 month progression-free survival (PFS) benefit did not outweigh the safety risks of treating MM patients who have received at least one prior therapy. Patients receiving the panobinostat combination in the Phase III PANORAMA-1 trial had twice as many on-study deaths and almost 50% more non-fatal serious adverse events than those receiving Velcade and dexamethasone without panobinostat (see BioCentury, Nov. 17). ...