ASCOPOST Publica en su Edición de Marzo ( Página 14 ) : Priority Review Granted for Trabectedin in Advanced Soft-Tissue Sarcoma .Una Publicación que llega a toda la Comunidad Científica Internacional .
Yondelis sera Evaluado por la FDA con una Fecha Tope de Julio ... pero en alguna ocasión la FDA ha Evaluado Fármacos con Antelación a la Fecha Tope para Satisfacer Necesidades Medicas ... un ejemplo reciente es el de la Aprobación del Fármaco de Pfizer : IBRANCE que se Aprobó con Dos meses de Antelación a los 6 que establece la FDA en los casos de Revisión Prioritaria .
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By The ASCO Post // March 25, 2015 .
The U.S. Food and Drug Administration (FDA) has granted Priority Review for the New Drug Application (NDA) for trabectedin to treat patients with advanced soft-tissue sarcoma, including liposarcoma and leiomyosarcoma subtypes, who have received prior chemotherapy including an anthracycline. The NDA for trabectedin was submitted to the FDA on November 24, 2014.
Trabectedin is a novel, multimodal, synthetically produced antitumor agent—originally derived from the sea squirt Ecteinascidia turbinata—that prevents tumor cells from multiplying.
The filing is based on the phase III randomized, open-label study ET743-SAR-3007. This trial is evaluating the safety and efficacy of trabectedin vs dacarbazine for the treatment of patients with advanced liposarcoma and leiomyosarcoma. Results will be presented at a later date.