P.D.: Dias después de que desde Japón se comunicara que Yondelis ha terminado con éxito el ensayo Pivotal y que se esta pendiente de fecha para ser presentado ante las autoridades Sanitarias para la obtención de Autorización de Comercialización en dicho Pais ... Oncologos de la Universidad de Colorado Denver publican que en EEUU se esta a la espera de que se publiquen los resultados obtenidos con Yondelis en la Fase III de Registro :Enrollment: 586
Study Start Date: June 2011
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Pero Yondelis no solo se centrara en obtener los Ok de Japón y de los Estados Unidos ... Hay que tener en cuenta tambien que Janssen ha realizado el mismo ensayo de Registro en Nueva Zelanda , Australia , Brasil y Sud-Africa .
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Curr Oncol Rep. 2014 Jun .Lopez JP, Gajdos C, Elias A.
Author information Department of Medicine, University of Colorado at Denver, Denver, CO, USA.
Abstract
Soft tissue sarcomas are a heterogenous group of malignancies with relatively high mortality rates.
The outlook for these patients has been poor, with only a few drugs showing measurable activity.
Trabectedin is a new alkylating agent with significant activity in sarcomas, but particularly in liposarcomas and leiomyosarcomas, both as a single agent or in combination with other drugs.
Phase I and II studies of trabectedin have shown measurable benefit. Currently there are several Phase III trials which have completed accrual to better study its use as a single agent or in combination therapy, although outcomes have not yet been reported.
Trabectedin (Yondelis) is approved for the treatment of sarcomas by the EMEA, but is not yet approved by the FDA, pending the results of the currently maturing phase III trials.