(ODAC) did not recommend the investigational compound LBH589, a pan-deacetylase inhibitor, for patients with previously treated multiple myeloma when used in combination with bortezomib [*] and dexamethasone
Novartis announced that the US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) did not recommend the investigational compound LBH589 (panobinostat), a pan-deacetylase (pan-DAC) inhibitor, for patients with previously treated multiple myeloma when used in combination with bortezomib[*] and dexamethasone.
The committee’s vote will be considered by the FDA in its review of the LBH589 new drug application (NDA), but the FDA is not bound to follow the Committee’s guidance. The final decision regarding US approval is made by the FDA.
“We are disappointed by this voting outcome and believe the results from our clinical trials provide strong evidence to support LBH589 as a potential first-in-class treatment option for multiple myeloma, a cancer where an unmet patient need exists,” said Bruno Strigini, President, Novartis Oncology. “We will continue to work with the FDA as it completes its review of the US application.”
Data presented included two clinical studies evaluating LBH589 in combination with bortezomib and dexamethasone for patients with relapsed or relapsed and refractory multiple myeloma: a phase III randomised, 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[1].
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(*)Trade name Velcade registered to Millennium Pharmaceuticals, Inc.
(1) Novartis LBH589 ODAC Briefing Book.