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Europe's CHMP backs Novartis' Farydak for third line treatment of myeloma

Jun. 26, 2015 1:52 PM ETNovartis AG (NVS) StockNVSBy: Douglas W. House, SA News Editor
  • 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.

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