- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval for Novartis' (NVS -1%) Farydak (panobinostat), in combination with bortezomib (Takeda's Velcade) and dexamethasone, for the treatment of adult patients with relapsed/refractory multiple myeloma who have received at least two prior regimens including bortezomib and an immunomodulatory agent. A final decision by the European Commission usually takes ~60 days. The FDA approved it in February.
- Multiple myeloma is a cancer of the plasma cells that affects ~84K Europeans. The cancer cells accumulate in the bone marrow where they crowd out healthy blood cells and produce abnormal proteins that cause kidney problems.
- Panobinostat is an HDAC (histone deacetylase) inhibitor. HDACs are a class of enzymes that play a key role in gene expression.