Novartis announced today that the European Commission has approved Farydak®
(panobinostat, previously known as LBH589) capsules, in combination
with bortezomib* and dexamethasone, for the treatment of adult patients
with relapsed and/or refractory multiple myeloma who have received at
least two prior regimens including bortezomib and an immunomodulatory
agent (IMiD). The approval of Farydak marks the first time a histone
deacetylase (HDAC) inhibitor with epigenetic activity is available in
the European Union (EU), providing a new treatment option for patients
living with multiple myeloma whose disease has progressed after
standard-of-care therapy.
Multiple myeloma is a cancer of the plasma cells, a type of white blood
cell present in the bone marrow, and affects approximately 84,000 people
in Europe. Farydak is the first HDAC inhibitor to show efficacy in
multiple myeloma. As an HDAC inhibitor, its epigenetic activity may
help restore cell function in patients with multiple myeloma.
Farydak in combination with bortezomib and dexamethasone is also
approved in the US, Chile and Japan for certain patients with previously
treated multiple myeloma. The exact indication for Farydak varies by
country. In the US, Farydak is approved in combination with bortezomib
and dexamethasone for the treatment of patients with multiple myeloma
who have received at least two prior regimens, including bortezomib and
an IMiD. Continued approval in the US may be contingent upon
verification and description of clinical benefit in confirmatory trials.
