Allos seeks re-exam of EMA CHMP opinion on FOLOTYN for PTCL Allos Therapeutics.
‘We look forward to working closely with our partner Mundipharma and the CHMP during the re-examination process.’ Pralatrexate has orphan medicinal item designation in Europe for the treatment of PTCL . In the E.U., orphan medicinal item designation is normally conferred upon investigational products for diseases that affect less than five in 10,000 patients. Products with orphan designation that are the first to be accepted for a specific indication, and continue steadily to meet the requirements for orphan designation, receive up to ten years of market exclusivity in the E.U.. Allos seeks re-exam of EMA CHMP opinion on FOLOTYN for PTCL Allos Therapeutics, Inc. PTCL comprises a varied group of aggressive biologically, rare blood cancers that have a even worse prognosis than most other types of lymphoma, including B-cell lymphoma. (more…)