Pharma Jonpi : Se esperaba que fuera primero en Japón la Presentación del Yondelis para el Tratamiento de Sarcomas dado que ya se presentaron los resultados en varios Congresos ... pero J&J ha sorprendido a Autoridades , Oncologos , Asociaciones de Pacientes , Analistas , Accionistas ... y ayer noche se Presentaban en la FDA para presentar el Dossier que pueda autorizar la Comercialización del Yondelis en EEUU y de rebote en Paises que dependen de la FDA .
J&J en su Presentación a Analistas ya comunicaba que entre sus planes 2014 - 2017 estaba el presentar Yondelis a la FDA ... no ha esperado ni a terminar 2014 .
Yondelis esta Aprobado Ya en 70 Paises ... pero EEUU tiene Más Peso , Prestigio y ... Más Ventas Oncologicas que todos los 70 Paises Juntos .
Se Estima que en 2014 se dieron 12.000 Nuevos casos de Sarcoma en EEUU y que unas 4.700 personas Morirán a causa de este Tipo de Tumor .
************************************************
Peter F. Lebowitz, Jefe de Oncología Global de Janssen Tras loa Presentación del Dossier del Yondelis :
Estamos particularmente orgullosos de esta solicitud, ya que muestra nuestro compromiso con Yondelis y con la gente a la que puede ayudar” .
“El tratamiento para el sarcoma de tejidos blancos avanzado ha estado estancado durante décadas y nuestra esperanza es que este fármaco sea una nueva opción para la gente que vive con esta agresiva enfermedad”, ha destacado.
************************************************
Zeltia comunicó ayer a última hora a la CNMV que Janssen Research & Development ha anunciado la presentación al regulador farmacéutico de Estados Unidos, la FDA, la solicitud de autorización de comercialización para Yondelis.
En concreto, para el tratamiento con este medicamento a los pacientes con sarcoma de tejidos blancos avanzado que han recibido previamente quimioterapia, incluyendo una Antraciclina .
************************************************
Comunicado :
Janssen Submits New Drug Application for YONDELIS® (trabectedin) to U.S. FDA for the Treatment of Patients with Advanced Soft Tissue Sarcoma .
Additionally, Trabectedin Expanded Access Program Now Allows Entry of Eligible Patients with Previously Treated Advanced Soft Tissue Sarcoma, Including those with Liposarcoma and Leiomyosarcoma .
RARITAN, N.J., Nov. 24, 2014 /PRNewswire/ -- Janssen Research & Development, LLC (Janssen) has submitted a New Drug Application (NDA) for YONDELIS® (trabectedin) to the U.S. Food and Drug Administration (FDA) for the treatment of patients with advanced soft tissue sarcoma (STS), including liposarcoma and leiomyosarcoma subtypes, who have received prior chemotherapy including an anthracycline.
"We are particularly proud of this filing, as it represents our commitment to YONDELIS and the people it may help," said Peter F. Lebowitz, M.D., Ph.D., Global Oncology Head, Janssen. "The advanced soft tissue sarcoma treatment landscape has been relatively stagnant for decades and it's our hope that YONDELIS will be a new treatment option for people living with this aggressive disease."
Janssen also announced plans to amend the protocol for the Phase 3 randomized, open-label study ET743-SAR-3007, on which the NDA submission is based. The protocol will be revised to offer patients who were randomized to the dacarbazine comparator arm the option of receiving trabectedin treatment at their physician's discretion. This trial is evaluating the safety and efficacy of trabectedin versus dacarbazine for the treatment of advanced liposarcoma and leiomyosarcoma, the most common types of STS in adults, in more than 500 patients previously treated with an anthracycline and ifosfamide, or an anthracycline followed by one additional line of chemotherapy. Results of the study will be presented at a future date.
"Today, we are one step closer to our goal of making another treatment option available for people living with advanced soft tissue sarcoma," said Denise Reinke, President and CEO of Sarcoma Alliance for Research through Collaboration. "People living with this type of cancer are in urgent need of new options to help treat their disease, and we welcome new medicines that may help make a difference in their lives."
In related news, Janssen will be revising the current U.S. trabectedin expanded access program (EAP), ET743-SAR-3002, to allow entry of eligible patients with liposarcoma and leiomyosarcoma. The program was developed to provide trabectedin to eligible patients with previously treated STS who cannot be expected to benefit from limited currently available therapeutic options. Patient enrollment will be extended to those with liposarcoma or leiomyosarcoma as soon as the protocol amendment is implemented at participating sites. Interested patients should discuss the option of accessing trabectedin through the EAP with their physician to understand if this is an appropriate option for them.
Information about the Study ET743-SAR-3007 (NCT01343277) and the EAP treatment protocol (NCT00210665) may be found on www.clinicaltrials.gov. U.S. healthcare professionals may also contact 1-800-JANSSEN.