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

ASHP 2016 - ASHP 2016 - Oncology, Conference Correspondent

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
Palliative Care Use Dismal Among Patients with Hematologic Malignancies
TON - March 2018, Vol 11, No 1 published on March 9, 2018 in Conference Correspondent, ASH, Palliative Care, Hematologic Cancers
Oral Multiple Myeloma Medication Linked to Decreased Productivity Loss
Chase Doyle
TON - March 2018, Vol 11, No 1 published on March 9, 2018 in Conference Correspondent, ASH, Multiple Myeloma
Ivosidenib, New IDH1 Inhibitor, Elicits Complete Response in Relapsed Acute Myeloid Leukemia
Wayne Kuznar
TON - March 2018, Vol 11, No 1 published on March 9, 2018 in Conference Correspondent, Drug Updates & News, ASH
“Superhero” Navigators Convene at the 8th Annual Navigation & Survivorship Conference
Meg Barbor, MPH
TON - March 2018, Vol 11, No 1 published on March 9, 2018 in Conference Correspondent, AONN+
Silent Patients Find Their Voices Through an Advocate’s Journey
Meg Barbor, MPH
TON - March 2018, Vol 11, No 1 published on March 9, 2018 in Patient Advocacy, Conference Correspondent, ESMO
Measuring Financial Well-Being in Cancer Survivorship
Meg Barbor, MPH
TON - March 2018, Vol 11, No 1 published on March 9, 2018 in Conference Correspondent, Survivorship
Combining Immunotherapy and Radiotherapy Shows Good Synergy
Chase Doyle
TON - March 2018, Vol 11, No 1 published on March 9, 2018 in Immunotherapy, Conference Correspondent
Quizartinib Combinations Show High Activity in Newly Diagnosed Acute Myeloid Leukemia with FLT3 Mutation
Wayne Kuznar
TON - March 2018, Vol 11, No 1 published on March 9, 2018 in Conference Correspondent, Drug Updates & News
Humanizing Cancer Care: The Patient Perspective
Gail Thompson
TON - March 2018, Vol 11, No 1 published on March 9, 2018 in Conference Correspondent, ACCC
Emerging Safety Data with Checkpoint Inhibitors
Phoebe Starr
TON - November 2017, Vol 10, No 6 published on November 27, 2017 in Conference Correspondent
Last modified: December 13, 2016