US FDA approves Novartis’ Farydak, the first HDAC inhibitor for MM patients

The US Food and Drug Administration yesterday approved Swiss pharma giant Novartis’ (NOVN: VX) Farydak (panobinostat, previously known as LBH589) capsules in combination with bortezomib (Takeda’s Velcade) and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior regimens, including bortezomib and an immunomodulatory (IMiD) agent.

The decision is something of a bonus for Novartis, given that last fall the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted against approval of the drug (The Pharma Letter November 7, 2014).

"Farydak represents an exciting agent with a new mechanism of action that is part of a promising class of drugs in this setting," said study investigator Paul Richardson, clinical program leader and director of clinical research at the Jerome Lipper Multiple Myeloma Center at Dana-Farber Cancer Institute. "Importantly, Farydak has been shown to improve progression-free survival in relapsed multiple myeloma patients who have received at least two prior regimens, including bortezomib and an IMiD, which is an area of particular unmet medical need," Dr Richardson added.