<em>Farydak</em> Confirmatory Trial To Come Years After Accelerated Approval

Farydak Confirmatory Trial To Come Years After Accelerated Approval

02 Mar 2015

Despite the agency’s preference that confirmatory trials generally be under way at the time of accelerated approval, Novartis’ panobinostat Phase III trial isn’t expected to begin for approximately three years.

FDA granted accelerated approval to Novartis AG’s HDAC inhibitor Farydak (panobinostat) for third-line treatment of multiple myeloma even though the drug’s Phase III confirmatory trial will not begin for approximately three years.

The agency’s approval letter includes two post-marketing trial requirements as a condition for accelerated approval: a Phase II...