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 .
31 julio 2007
Yondelis , Resultados en Pacientes con Sarcomas Tejido Blando avanzados . 3 Agosto 2007 . 50% Estabilizacion , 29% vivos a los 2 años .
2007 Aug 3
Trabectedin (ET-743): evaluation of its use in advanced soft-tissue sarcoma.
Schöffski P, Wolter P, Clement P, Sciot R, De Wever I, Wozniak A, Stefan C, Dumez H.
Leuven Cancer Institute, Department of General Medical Oncology, University Hospital Gasthuisberg, Catholic University Leuven, Herestraat 49, 3000 Leuven, Belgium
Trabectedin (ET-743; Yondelis((R))) is a novel DNA-binding agent, originally derived from the marine tunicate, Ecteinascidia turbinata, and now produced synthetically. The efficacy of trabectedin in patients with advanced soft-tissue sarcoma has been demonstrated in three Phase II studies involving 189 previously treated patients. A pooled analysis of data from these studies showed that trabectedin induced tumor control (objective responses plus disease stabilization) in approximately 50% of patients; median overall survival was 10.3 months and progression-free survival at 6 months was 19.8%, with 29.3% of patients alive at 2 years. Responses were achieved in patients who were resistant to both doxorubicin and ifosfamide. Trabectedin is generally well tolerated, with adverse events being noncumulative, reversible and manageable. Unlike other commonly used cytotoxic agents, trabectedin is not associated with cardiotoxicity or neurotoxicity and alopecia is rare. Trabectedin is an interesting new anticancer agent that offers much promise for the treatment of advanced soft-tissue sarcoma.
Trabectedin (ET-743): evaluation of its use in advanced soft-tissue sarcoma.
Schöffski P, Wolter P, Clement P, Sciot R, De Wever I, Wozniak A, Stefan C, Dumez H.
Leuven Cancer Institute, Department of General Medical Oncology, University Hospital Gasthuisberg, Catholic University Leuven, Herestraat 49, 3000 Leuven, Belgium
Trabectedin (ET-743; Yondelis((R))) is a novel DNA-binding agent, originally derived from the marine tunicate, Ecteinascidia turbinata, and now produced synthetically. The efficacy of trabectedin in patients with advanced soft-tissue sarcoma has been demonstrated in three Phase II studies involving 189 previously treated patients. A pooled analysis of data from these studies showed that trabectedin induced tumor control (objective responses plus disease stabilization) in approximately 50% of patients; median overall survival was 10.3 months and progression-free survival at 6 months was 19.8%, with 29.3% of patients alive at 2 years. Responses were achieved in patients who were resistant to both doxorubicin and ifosfamide. Trabectedin is generally well tolerated, with adverse events being noncumulative, reversible and manageable. Unlike other commonly used cytotoxic agents, trabectedin is not associated with cardiotoxicity or neurotoxicity and alopecia is rare. Trabectedin is an interesting new anticancer agent that offers much promise for the treatment of advanced soft-tissue sarcoma.
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