Panobinostat Recommended by CHMP for EU Approval to Treat Multiple Myeloma

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) have adopted a positive opinion for Novartis’ capsules. This involves combination of panobinostat capsules 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). If approved, panobinostat will be first in its class of anticancer agents available to these patients.

Panobinostat is the first HDAC inhibitor recommended by the CHMP for patients with multiple myeloma. Multiple myeloma is a cancer of the plasma cells, and affects approximately 84,000 people in Europe. Panobinostat is the first histone deacetylase (HDAC) inhibitor which has shown efficacy in multiple myeloma. As an HDAC inhibitor, its epigenetic activity may help restore cell function in patients with multiple myeloma.

The recommendation is based on efficacy and safety data in a subgroup analysis of 147 patients during a Phase III trial. Results showed that the median progression-free survival (PFS) benefit increased in panobinostat patients who had received prior treatment with both bortezomib and an IMiD, as compared to the placebo arm.

Alessandro Riva, MD, Global Head of Oncology Development and Medical Affairs at Novartis Oncology commented “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.”


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