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Allos Therapeutics, Inc. Announces FDA Advisory Committee Recommends Accelerated Approval of FOLOTYN (pralatrexate) For The Treatment of Patients
6:09pm EDT
Allos Therapeutics, Inc. announced that the U.S. Food and Drug Administration`s (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 10-4 that the response rate and duration of response observed with FOLOTYNTM (pralatrexate) are reasonably likely to predict clinical benefit in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). PTCL comprises a biologically diverse group of aggressive blood cancers that has a worse prognosis than most other types of lymphoma, including B-cell lymphoma. If approved, FOLOTYN would be the first drug approved by the FDA for the treatment of relapsed or refractory PTCL