Farydak is the first histone deacetylase (HDAC) inhibitor approved in combination with bortezomib, a type of chemotherapy, and dexamethasone, an anti-inflammatory medication, to treat these patients who received at least two prior regimens including bortezomib and immunomodulatory (IMiD).
If approved by the EMA, panobinostat will be first in its class of anticancer agents available to these patients in the EU.
As an HDAC inhibitor, panobinostat’s epigenetic activity may help to restore cell function in multiple myeloma.
Novartis Oncology Oncology Development and Medical Affairs global head Alessandro Riva said: "Panobinostat is the first and only HDAC inhibitor recommended by the CHMP for the treatment of patients living with multiple myeloma who have progressed after standard-of-care therapy with bortezomib and an IMiD.
"We are pleased with the positive CHMP opinion on panobinostat for previously treated patients because it brings us one step closer to providing a new treatment option for patients in need in Europe."
The EMA positive opinion is based on efficacy and safety data in a subgroup analysis of 147 patients who had received at least two prior regimens, including bortezomib and an IMiD, during the randomized, double-blind, placebo-controlled, multicenter global registration Phase III PANORAMA-1 (PANobinostat ORAl in Multiple MyelomA) trial.
The trial evaluated panobinostat in combination with bortezomib and dexamethasone against bortezomib and dexamethasone alone in patients with relapsed and/or relapsed and refractory multiple myeloma.
Image: The EMA’s CHMP recommendation is based on efficacy and safety data from Phase III PANORAMA-1 trial. Photo: courtesy of Michelle Meiklejohn/ freedigitalphotos.net.