FDA approves Spectrum's belinostat

FDA granted accelerated approval to Beleodaq belinostat from Spectrum Pharmaceuticals Inc. (NASDAQ:SPPI) to treat relapsed or refractory peripheral T-cell lymphoma (PTCL). The approval came nearly a month ahead of the Aug. 9 PDUFA date. Spectrum plans to launch the product this month. Spectrum said FDA post-marketing requirements include a three-arm trial evaluating Beleodaq or Spectrum's marketed PTCL product Folotyn pralatrexate in combination with CHOP chemotherapy vs. CHOP chemotherapy alone. Spectrum declined to disclose pricing information and said details of the trial design have yet to be determined. ...