El Instituto Alemán de Calidad y Eficiencia en la Atención de la Salud (IQWiG) ha publicado un informe que sugiere que por razones de forma o metodológicas, respectivamente, no encuentra ningún beneficio adicional demostrable para Halaven frente a los tratamientos de comparación establecidos - como lo define el Conjunto Federal Comité (G-BA) - para el Tratamiento de Liposarcoma Avanzado o Metastásico no Resecable.05-09-2016 .
The German Institute for Quality and Efficiency in Health Care (IQWiG) has published a report which suggests that on formal or methodological grounds, respectively, no additional benefit has been proven for Halaven (eribulin) versus established comparator therapies - as defined by the Federal Joint Committee (G-BA) - for the treatment of unresectable advanced or metastatic liposarcomas.
The dossier submitted by Japan’s Eisai (TYO: 4523) for the assessment included a direct comparison to dacarbazine (based on Eisai's Phase III study 309) as well as an indirect comparison to trabectedin. With its suggestion, the IQWiG ignores pivotal Phase III data which demonstrated clearly that eribulin is the first and only single agent therapy to show a statistically significant overall survival advantage in advanced liposarcoma, said Eisai.
"Eribulin has demonstrated a statistically-significant survival advantage over dacarbazine in the treatment of advanced liposarcoma. This is a very rare and difficult to treat type of soft tissue sarcoma for which treatment options are few and existing therapies are associated with only limited efficacy. The clinical importance of this unprecedented survival benefit cannot be overstated for people who live with advanced liposarcoma and urgently need new and effective treatment options, such as eribulin," comments Dr Helga Schmitz, medical director, Eisai GmbH.
The final decision on the additional benefit of eribulin lies with the G-BA and is expected for the end of December 2016, following due and balanced consideration of all relevant aspects of the IQWiG report, written statements and an oral hearing of experts and patient representatives.
“Eisai cannot understand the suggestion of the IQWiG that no additional benefit has been proven for eribulin, despite compelling Phase III data which show an overall survival benefit. We are hopeful that, notwithstanding the report by IQWIG, the G-BA will take a more informed view," comments Dr Patrik Höller, Director Oncology Business Group, Eisai GmbH.
In May 2016, the European Commission approved a variation to the terms of the Marketing Authorization (MA) of eribulin for the treatment of adult patients with unresectable liposarcomas who have received prior anthracycline containing therapy (unless unsuitable) for advanced or metastatic disease.
Eribulin is also licensed in Europe for the treatment of patients with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimen for advanced disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting, unless patients were not suitable for these treatments.
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En Relación a Halaven como posible Competidor de Yondelis en el Tratamiento de Liposarcomas :
Link : Yondelis versus Eribulin Según el Dr. Ian Judson : Eribulin No es Más Activo que la Dacarbazina en las Medidas Convencionales de Eficacia . Yondelis Aporta a los Pacientes un Beneficio Clinico Prolongado del 20 al 30 % .