Options for Peripheral T-cell Lymphoma .
15 - 12 - 2008 .
There may not yet be any treatments approved for peripheral T-cell lymphoma (PTCL), an aggressive subset of non-Hodgkin's lymphoma, but ASH highlighted several nearing the end of the pipeline.
Allos Therapeutics Inc. presented top-line data from a pivotal Phase II trial of pralatrexate (PDX) showing a 27 percent response rate and 11 complete responses in the trial's 109 heavily pretreated PTCL patients. Analysts predicted the data will be sufficient for approval, and the company plans to submit a new drug application in the first half of 2009.
Meanwhile Gloucester, which also has a pivotal PTCL trial underway, presented Phase II data showing that romidepsin induced a 44 percent response rate, with four of 34 evaluable patients classified as complete responders. Additionally, PharmaMar SA said a subset of PTCL patients in its Phase II Aplidin (plitidepsin) study achieved a 36 percent response rate. And Amgen Inc.'s CCR4-targeted antibody, which it licensed from Kyowa Hakko Kogyo Co. Ltd. in a potential $520 million deal earlier this year, was the subject of a Phase I poster showing that the drug induced a complete response in the only PTCL patient in the study.
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DESPUES DE 18 AÑOS CON SOLO TOPOTECAN CON FULL APPROVAL EN EEUU COMO TREATMENT 2a LÍNE SCLC-ES ... LA USFDA ACABA DE APROBAR AL TARLATAMAB CON FULL APPROVAL ... POR LO QUE ES YA EL NEW TREATMENT STÁNDARD EN EEUU . TIENE APROBACIÓNES ACELERADAS EN CANADA , UK, COREA ... Y EN DÍAS PODRÍA ALCANZAR LA APROBACIÓN TAMBIÉN EN CHINA QUE EN JULIO 2025, LA NMPA ACEPTÓ LA SOLICITUD DE REGISTRO (NDA) PARA TARLA OTORGÁNDOLE ADEMAS LA REVISIÓN PRIORITARIA . LA EMA TAMBIÉN LO ESTÁ YA EVALUANDO .