FDA Reverses ODAC Vote and Approves Panobinostat (Farydak®) for Relapsed Myeloma

In a surprise move this week, the US Food and Drug Administration (FDA) approved Farydak®, despite the 5-2 vote by the FDA’s Oncologic Drugs Advisory Committee (ODAC) recommending against approval in November 2014. The approval is obviously good news for the myeloma community.

Surprise rejection of panobinostat for approval by 5-2 margin at ODAC Hearing

Today's Oncologic Drugs Advisory Committee (ODAC) hearing convened in an optimistic fashion with many in the myeloma community expecting there would be a recommendation for approval of panobinostat, an HDAC inhibitor used in combination with Velcade and dexamethasone. Publicly available data indicated a 3.9 months progression-free survival (PFS) or remission duration benefit with the three-drug panobinostat combination in patients who had been treated with 1-3 prior therapies.

Pomalidomide Update

The US Food and Drug Administration (FDA) has cancelled the planned November advisory committee (ODAC) meeting for Celgene's pomalidomide application.  Celgene, in a press release, indicated that the pomalidomide application is continuing, which means that a decision with regard to pomalidomide is still expected on or before February 10, 2013.