Click Here to
Subscribe
Breaking
News, Updates,
& More
Stay Up
to Date

Latest Developments in Short-Acting Granulocyte Colony-Stimulating Factor (G-CSF) Treatment Options: The First FDA-Approved Biosimilar, Zarxio® (filgrastim-sndz)

Conference Correspondent  - Conference Correspondent, ASHP

Ali McBride, PharmD, MS, BCPS, clinical coordinator of hematology/oncology at the University of Arizona Cancer Center, presented the latest developments on the first FDA-approved biosimilar, Zarxio® (filgrastim-sndz).

Zarxio (filgrastim-sndz) is a recently approved colony-stimulating factor and a biosimilar to the reference product, Neupogen (filgrastim). 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 transplantation, patients undergoing peripheral blood progenitor-cell collection and therapy, and patients with severe chronic neutropenia.1

Zarxio met all 5 biosimilar standards: demonstrating high similarity in analytical data, animal studies, and clinical studies while maintaining the same mechanism of action and route of administration, dosage forms, and strength as the reference product. Biosimilarity of Zarxio to Neupogen was confirmed by the PIONEER study and a pharmacokinetic/pharmacodynamics study that reported no difference in safety, purity, and potency between the 2 products.1

The PIONEER study was a randomized, double-blind comparative study that analyzed the efficacy and safety between Zarxio and Neupogen for 24 weeks.2 The primary end point tested was comparative equivalency assessment of mean duration of severe neutropenia between Zarxio and Neupogen at cycle 1. A total of 218 patients with breast cancer were randomized and received 6 cycles of Taxotere (docetaxel), Adriamycin (doxorubicin), and cyclophosphamide, and received either Zarxio or Neupogen daily starting on day 2 of each cycle.2 In cycle 1, the mean duration of severe neutropenia (DSN) was 1.17 days with Zarxio versus 1.2 days with Neupogen (DSN difference for Neupogen minus Zarxio [90% confidence interval] 0.04 days). The study also determined that the safety profile of Zarxio compared with Neupogen was not markedly different, and equivalence between products was demonstrated.

McBride A. Product theater presentation at ASHP Midyear Clinical Meeting. Las Vegas, NV; December 2016.

  1. ZARXIO Prescribing Information. Sandoz Inc. March 2016. 
  2. Blackwell K, et al. Ann Oncol. 2015; 26(9):1948-1953.
Related Items
A Look at SIRT Y-90 and the SARAH Trial
Valérie Vilgrain, MD
Videos published on May 11, 2017 in Conference Correspondent, Video, ILC
Nursing Implications of Chimeric Antigen Receptor T-Cell Therapy
Conference Correspondent  published on May 4, 2017 in Conference Correspondent, ONS
Neratinib After Trastuzumab-Based Adjuvant Therapy in Early-Stage HER2+ Breast Cancer: 5-Year Interim Analysis from the ExteNET Trial
Conference Correspondent  published on May 4, 2017 in Conference Correspondent, ONS
Alternative Dosing Schedules to Manage Adverse Events in Patients with Metastatic Renal-Cell Carcinoma Receiving Sunitinib
Conference Correspondent  published on May 4, 2017 in Conference Correspondent, ONS
Treatment-Related Adverse Events with Nivolumab in Patients with Relapsed or Refractory Classical Hodgkin Lymphoma in the Phase 2 CheckMate-205 Study
Conference Correspondent  published on May 4, 2017 in Conference Correspondent, ONS
Implication of Rituximab Priming Practices
Conference Correspondent  published on May 4, 2017 in Conference Correspondent, ONS
Standardization of Patient Assessments and Administration Guidelines for Blinatumomab
Conference Correspondent  published on May 4, 2017 in Conference Correspondent, ONS
What Is the Status of Immunotherapeutic Agents Playing a Role in the Treatment of SCLC, and How Should Oncology Nurses Educate and Prepare Patients?
Conference Correspondent  published on May 4, 2017 in Conference Correspondent, ONS
Turning on the Light Switch: Development and Implementation of an Immunotherapy Program for a Community-Based Oncology Practice
Conference Correspondent  published on May 4, 2017 in Conference Correspondent, ONS
Identifying and Treating Cytokine Release Syndrome
Conference Correspondent  published on May 3, 2017 in Conference Correspondent, ONS
Last modified: April 27, 2020