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FDA Approves Panobinostat for Multiple Myeloma
Accelerated approval due to progression-free survival
Indications: Panobinostat (Farydak) is indicated for patients with multiple myeloma who have received at least 2 prior regimens, and should be administered in combination with bortezomib and dexamethasone.
Dosing: The recommended dose is 20 mg, taken orally, every other day in 3 doses per week for 2 weeks of a 21-day cycle, and continued for 8 cycles.
Pharmacokinetics: Panobinostat is a histone deacetylase inhibitor. Peak concentrations occur within 2 hours of oral administration. It is metabolized extensively through reduction, hydrolysis, oxidation, and glucuronidation processes. It is excreted in urine and feces.
Drug Interactions: Use with caution with CYP3A4 inhibitors, inducers and substrates.
Side Effects/Risks: The most common adverse reactions include diarrhea, fatigue, nausea, peripheral edema, decreased appetite, pyrexia, and vomiting.
More Information: The FDA granted panobinostat accelerated approval based on progression-free survival.
Source: Highlights of prescribing information: Farydak (panobinostat). U.S. Food & Drug Administration website. http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205353s000lbl.pdf. Revised February 2015. Accessed March 3, 2015.