30 November 2021 - Secura Bio announced today that, based on discussions with the U.S. FDA, Secura Bio has submitted to FDA for the withdrawal of the approval of Farydak (panobinostat) oral capsules.
Farydak received accelerated approval in February 2015 for use in combination with bortezomib and dexamethasone to treat patients with multiple myeloma who have received at least two prior regimens, including bortezomib and an immunomodulatory agent.
Secura Bio acquired Farydak in March 2019.