FDA Approves Panobinostat for Multiple Myeloma

February 23, 2015 8:22 PM

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The FDA has approved panobinostat (Farydak) in combination with bortezomib (Velcade) and dexamethasone for patients with multiple myeloma who receive prior treatment with bortezomib and an immunomodulatory (IMiD) agent, based on a prespecified subgroup analysis from the PANORAMA-1 trial.

The prespecified analysis looked specifically at 193 patients from the phase III study who were treated with bortezomib and an IMiD. In this population, the median progression-free survival (PFS) with the panobinostat combination was 10.6 months versus 5.8 months with placebo (HR = 0.52; 95% CI, 0.3...

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