Beleodaq belinostat regulatory update

FDA granted accelerated approval to Beleodaq belinostat from Spectrum to treat relapsed or refractory peripheral T-cell lymphoma (PTCL). The approval came more than a month ahead of the Aug. 9 PDUFA date. Spectrum plans to launch the product this month. Spectrum said FDA postmarketing requirements include a 3-arm trial comparing Beleodaq or Folotyn pralatrexate - Spectrum’s marketed drug for PTCL - 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. ...