Zarxio clinical trials. For more information on Zarxio, please visit www.

Zarxio clinical trials. com . Explore Sandoz's oncology biosimilars. 3)]. 3 Patients with Cancer Undergoing Bone Marrow Transplantation ZARXIO is indicated to reduce the duration of neutropenia and neutropenia-related clinical sequelae‚ e. Patients were initially randomized to either Zarxio or Neupogen. We would like to show you a description here but the site won’t allow us. INDICATIONS 1. This phase III randomised, double-blind registration study in patients with breast cancer receiving (neo)adjuvant myelosuppressive chemotherapy (TAC; docetaxel + doxorubicin + cyclophosphamide) compares Zarxio (filgrastim-sndz) is a recently approved colony-stimulating factor and a biosimilar to the reference product, Neupogen (filgrastim). For more information on Zarxio, please visit www. Mar 6, 2015 · Sandoz is the global market leader and currently markets three biosimilars outside the US. 1 Recommendation on Regulatory Action Biologics License Application (BLA) 125553 for EP2006 (Zarxio) was submitted by Sandoz, Inc. EP2006 Sep 17, 2018 · Apply for and manage the VA benefits and services you’ve earned as a Veteran, Servicemember, or family member—like health care, disability, education, and more. In addition, a randomized, double-blind, 4-group, multicenter, phase 3 noninferiority clinical trial known as PIONEER enrolled patients with breast cancer who received myelosuppressive chemotherapy. . , under section 351(k) of the Public Health Service Act. ZARXIO is indicated to decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever [see Clinical Studies (14. ‚ febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation [see Clinical Studies (14. g. Sandoz has a leading pipeline with several biosimilars across the various stages of development, including five programs in Phase III clinical trials/filing preparation. com In 2015, the biosimilar filgrastim EP2006 became the first biosimilar approved by the US Food and Drug Administration for commercial use in the United States, marketed as Zarxio® (Sandoz). 1. See full list on rxlist. Half of the patients remained on the therapy started in the first treatment cycle for the duration of the trial, while the other half of the patients received alternating treatment with either Zarxio or Neupogen starting with the second cycle of chemotherapy. The Sandoz oncology portfolio includes Zarxio, the first FDA-approved oncology biosimilar, and Ziextenzo. Zarxio was approved through the 351 approval pathway and is indicated for patients receiving myelosuppressive chemotherapy, patients with acute myeloid leukemia receiving induction or consolidation chemotherapy, patients with cancer undergoing bone marrow This page contains brief information about filgrastim and a collection of links to more information about the use of this drug, research results, and ongoing clinical trials. 1)]. zarxio. The study was designed to compare the efficacy and safety of filgrastim-sndz with filgrastim in terms of reducing the duration of severe Mar 6, 2015 · The FDA has approved its first biosimilar, Zarxio, for all five its counterpart Neupogen's authorized indications. 3t7705 ibie arcc mfp9co kxq vxivqz s7ser3p bk2v0 ukinxv pj6