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In what was described as a very difficult decision, ODAC voted 5-2 against the accelerated approval of the HDAC inhibitor panobinostat in combination with bortezomib and dexamethasone as a treatment for patients with multiple myeloma who have received at least one prior therapy.

The FDA has expanded the bortezomib (Velcade) label to allow for retreatment in patients with multiple myeloma who previously responded to the proteasome inhibitor, according to an announcement made by Millennium/Takeda, the companies that manufacture the drug.

The combination of carfilzomib (Kyprolis), lenalidomide (Revlimid), and low-dose dexamethasone extended progression-free survival (PFS) by 8.7 months compared with lenalidomide and dexamethasone alone for patients with relapsed multiple myeloma