Post-Market Requirements Could Broaden Label For Allos' Newly Approved PTCL Drug Folotyn
This article was originally published in The Pink Sheet Daily
Executive SummaryAllos gains its first U.S. indication with the accelerated approval of Folotyn (pralatrexate) in peripheral T-cell lymphoma.
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With Spectrum’s Beleodaq’s accelerated approval for peripheral T-cell lymphoma, FDA rolls Folotyn accelerated approval requirement into one post-marketing trial that will provide answers on both drugs – including which is better against standard of care.