The US Food and Drug Administration (FDA) has approved the use of panobinostat for relapsed myeloma patients who have received at least two prior lines of treatment, including Velcade® and an immunomodulatory drug, making it the first histone deacetylase (HDAC) inhibitor to be approved for myeloma. Based on the overall results of the Phase III PANORAMA-1 trial, panobinostat had previously received a negative recommendation from the FDA’s Oncologic Drugs Advisory Committee. In response, Novartis, the manufacturer of the drug, presented additional data showing a significant progression free survival benefit of panobinostat in a subgroup of patients i.e. those who had already had more than two prior lines of treatment. Its approval in this setting will see panobinostat being used in combination with Velcade and dexamethasone. It will also be referred to by its brand name, Farydak®.

 

Read full article