EMA’s CHMP Recommends Novartis’ Myeloma Drug
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for Farydak (panobinostat, previously known as LBH589) capsules, in combination 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).
Farydak, an HDAC inhibitor, has an impact on epigenetics and may help restore cell function in patients with multiple myeloma. Panobinostat is approved as Farydak in the US and Chile in combination with bortezomib and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior regimens, including bortezomib and an IMiD. Additional regulatory submissions for Farydak are being reviewed by health authorities worldwide.