07/06/2011 Human medicines European Public Assessment Report (EPAR): Yondelis,
trabectedin
Revision: 6, Authorised .
The CHMP, having reviewed the evidence of compliance with the specific obligations submitted by the MAH and having reassessed the benefit/risk profile of the medicinal product, concluded that the benefit/risk balance for the product remains favourable.
Pharmaco-therapeutic Group .
Antineoplastic agents .
Therapeutic Indication :
Yondelis is indicated for the treatment of patients with advanced soft tissue sarcoma, after failure of anthracyclines and ifosfamide, or who are unsuited to receive these agents. Efficacy data are based mainly on liposarcoma and leiomyosarcoma patients.
Yondelis in combination with pegylated liposomal doxorubicin (PLD) is indicated for the treatment of patients with relapsed platinum-sensitive ovarian cancer.
4 TRATAMIENTOS SCLC-ES EN 1.ª LINE EN EUROPA : ATEZOLIZUMAB, DURVALUMAB ,SERPLULIMAB Y TISLELIZUMAB.
LURBINECTEDIN CON IMFORTE TODO EL MUNDO SABE QUE DE APROBARSE NO SERÍA PARA TRATAMIENTO DE PRIMERA LÍNEA .... SINO QUE SERÍA PARA EL MANTENIMIENTO EN EL ENTORNO DE PRIMERA LÍNEA ... O SEA SERÍA UN TRATAMIENTO TRAS LA PRIMERA LÍNEA DE INDUCCIÓN ... PARA QUE LOS PACIENTES NO SE VAYAN A SEGUNDA LÍNEA .