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Novartis works around negative Ad Comm vote for panobinostat approval

Feb. 23, 2015 3:55 PM ETNovartis AG (NVS) StockNVSBy: Douglas W. House, SA News Editor
  • The FDA approves Novartis' (NVS +0.3%) Farydak (panobinostat) for the treatment of patients with multiple myeloma (MM), the first histone deacetylase (HDAC) inhibitor cleared for this indication. It is intended for patients who have received two prior standard therapies, including bortezomib (Velcade) and an immunomodulatory agent. Farydak should be used in combination with bortezomib, a chemotherapy agent, and dexamethasone, a corticosteroid anti-inflammatory medicine.
  • In November, the Oncologic Drugs Advisory Committee voted 5 - 2 that the benefits of panobinostat did not outweigh the risks. After the meeting, the company submitted additional data supporting the use of Farydak in MM patients who had received at least two prior standard therapies, including bortezomib and dexamethasone.
  • Multiple myeloma afflicts ~22K Americans each year, with ~50% mortality rate within the first year of diagnosis.
  • Previously: Ad Comm votes against panobinostat (Nov. 6, 2014)
  • Previously: Priority review period for Novartis cancer drug extended (Nov. 25, 2014)

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