Sandoz gets marketing pass in EU for Ziextenzo, for helping treat cancer with cytotoxic chemotherapy in adults
November 27, 2018Novartis’ Sandoz, received on Tuesday from the European Commission (EC) the marketing authorization for biosimilar Ziextenzo (pegfilgrastim), which is indicated to reduce the duration of neutropenia and incidence of febrile neutropenia in adult patients treated with cytotoxic (anti-cancer) chemotherapy for malignancy with the exception of chronic myeloid leukemia and myelodysplastic syndromes.
Stefan Hendriks, Global Head of Biopharmaceuticals, Sandoz, said: “Despite advancements in cancer treatment, febrile neutropenia remains one of the most significant complications of chemotherapy and is a major cause of morbidity. With the approval of Ziextenzo, a long-acting version of oncology supportive medicine filgrastim, we look forward to providing a treatment option that delivers the possibility of further reducing both the personal and financial burden of cancer.”
Sandoz noted that the approval was based on comprehensive analytical, preclinical and clinical data.
Dr. Paul Cornes, oncologist from the Continuing Medical Education program of the European Association of Hospital Pharmacists and Core Lecturer for the European School of Oncology, United Kingdom, said that medicines like Ziextenzo help deliver optimized long-acting dosing and patient convenience while creating savings for our hard-pressed health systems.