First HDAC inhibitor for treatment of MM recommended for approval in EU

The European Medicines Agency’s Medicinal Products for Human Use (CHMP) has recommended granting a marketing authorization for Swiss pharma giant Novartis’ (NOVN: VX) Farydak (panobinostat) for the treatment of multiple myeloma.

Farydak is the first cancer drug that targets enzymes known as histone deacetylases or HDACs, which are involved in turning genes ‘on’ and ‘off’ within cells. It is intended for patients with relapsed and/or refractory multiple myeloma who have received at least two prior standard therapies, including bortezomib and an immunomodulatory agent. It is to be used in combination with bortezomib and the anti-inflammatory medicine dexamethasone.

However, there are other drugs in Phase III clinical trials, with analysts particularly excited about the first generation of monoclonal antibodies (MAbs) for multiple myeloma. These include Janssen and Genmab’s CD38-targeting antibody, daratumumab, and the anti-CS1 antibody, elotuzumab, from Bristol-Myers Squibb and AbbVie.