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Allos Therapeutics Requests Re-Examination of CHMP Opinion on FOLOTYN in PTCL at the European Medicines Agency

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Allos Therapeutics, Inc. (NASDAQ: ALTH) today announced that it has submitted a request to the European Medicines Agency (EMA) for a re-examination of the negative opinion issued in January by the EMA's Committee For Medicinal Products for Human Use (CHMP) for conditional approval of FOLOTYN^ for the treatment of patients with peripheral T-cell lymphoma whose disease has progressed after at least one prior systemic therapy. PTCL comprises a biologically diverse group of aggressive, rare blood cancers that have a worse prognosis than most other types of lymphoma, including B-cell lymphoma. According to current CHMP guidelines, a final opinion on the re-examination could be issued by the EMA within four to five months.

Posted-In: News FDA

 

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