publication date: Nov. 14, 2014
ODAC Votes Against Approving Farydak in Multiple Myeloma
The FDA Oncologic Drugs Advisory Committee recommended against approval of the Novartis agent Farydak (panobinostat), a pan-deacetylase inhibitor, for the indication of previously treated multiple myeloma when used in combination with bortezomib and dexamethasone.
ODAC voted 5-2 against approval Nov. 6, noting that while the agent had demonstrated an improvement in progression-free survival, its side effects were too severe to warrant approval.
The application was based on a phase III randomized, double-blind, placebo-controlled, global registration trial called PANORAMA-1 (PANobinostat ORAl in Multiple MyelomA) and a phase II multicenter, single-arm, open-label study in the U.S. named PANORAMA-2.
PANORAMA-1 enrolled 768 patients with relapsed multiple myeloma in a pivotal, add-on design trial that used bortezomib and dexamethasone as backbone therapy. The primary endpoint was investigator-assessed progression-free survival. The secondary endpoint was overall survival. PFS was also assessed by an independent review committee in a sensitivity analysis, due to large amounts of incomplete response assessment data.
According to FDA briefing documents, Farydak produced an improvement in median progression-free survival of 3.9 months as assessed by investigators, or 2.2 months as assessed by independent review committee.
However, there was an increased incidence of deaths not due to progressive disease—7 percent vs. 3.5 percent—and the observed adverse events of myelosuppression, hemorrhage, infection, gastrointestinal toxicity, and cardiac toxicity.
ODAC was asked to determine whether the benefit of treatment with Farydak, also known as LBH589, in combination with bortezomib and dexamethasone outweighs the risks for patients with relapsed … Continue reading 40-43 ODAC Votes Against Approving Farydak in Multiple Myeloma
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