FDA Greenlights Ennumo: New Supportive Care Option for Oncology Nurses

The landscape of oncology supportive care continues to evolve with the U.S. Food and Drug Administration (FDA) approval of Ennumo (pegfilgrastim-pccg) on July 9. As a biosimilar to Neulasta (pegfilgrastim), Ennumo offers oncology nurses and their patients a new option for managing one of the most taxing side effects of cancer treatment: febrile neutropenia.

A comprehensive toolkit for neutropenia management

With this approval, Accord BioPharma becomes the first company in the United States to offer two distinct pegfilgrastim biosimilars — Ennumo and Udenyca (pegfilgrastim-cbqv) — alongside its short-acting G-CSF biosimilar, Filkri (filgrastim-laha). For the oncology nurse, who often serves as the primary coordinator of care and advocate for patient access, this portfolio provides increased flexibility to meet diverse clinical and operational needs.

Febrile neutropenia remains a significant hurdle in oncology, often leading to treatment delays, dose reductions, and increased risk of hospitalization or mortality.

Clinical indications and administration

Ennumo is indicated for use in both adult and pediatric patients, including newborns, to decrease the incidence of infection — manifested as febrile neutropenia — in those with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs. Additionally, it is approved to increase survival in patients acutely exposed to myelosuppressive doses of radiation, known as Hematopoietic Subsyndrome of Acute Radiation Syndrome.

For bedside administration, nurses should note that Ennumo is supplied as a 6 mg/0.6 mL single-dose prefilled syringe intended for manual use. It is important to remember that Ennumo is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

Safety considerations: Monitoring and education

As the primary monitors of patient safety, oncology nurses must be vigilant for several serious, though rare, adverse events associated with pegfilgrastim products.

• Splenic rupture: Nurses should educate patients to report any left upper abdominal or shoulder pain immediately, as splenic rupture — including fatal cases — can occur.
• Acute respiratory distress syndrome (ARDS): Evaluate patients who develop fever, lung infiltrates, or respiratory distress for ARDS. If suspected, the medication must be discontinued.
• Serious hypersensitivity: Anaphylaxis can occur, often upon initial exposure. If a serious reaction is observed, ENNUMO should be permanently discontinued.
• Sickle cell crisis: Severe and sometimes fatal crises can occur in patients with underlying sickle cell disorders.
• Renal health: Monitor for signs of glomerulonephritis, which may present as azotemia, hematuria, or proteinuria.
• Laboratory monitoring: Regular monitoring of complete blood counts (CBC), including white blood cell and platelet counts, is recommended to manage risks of leukocytosis and thrombocytopenia.

The most common adverse reactions nurses can expect to manage are bone pain and pain in extremity, occurring in 5% or more of patients compared to placebo.

Expanding patient access

The introduction of biosimilars like Ennumo is part of Accord BioPharma’s "20 by 2030" strategy, which aims to launch 20 biosimilar products in the U.S. by the end of the decade. This mission centers on expanding access to affordable biologic therapies, a goal that aligns with the nursing imperative to reduce barriers to care.

"Every FDA approval marks a step forward in our mission to expand patient access to high-quality, affordable biologic therapies," said Chrys Kokino, President of Accord North America, in a news release announcing the approval. For the oncology nursing community, this means more tools to ensure that patients can remain on their prescribed chemotherapy schedules while minimizing the life-threatening risks associated with neutropenia.

As more biosimilar options enter the market, oncology nurses will continue to play a pivotal role in educating patients about these therapies and ensuring their safe integration into standard oncology workflows.

Reference

1. FDA Approves ENNUMO™ (pegfilgrastim-pccg), Accord BioPharma's Second Pegfilgrastim Biosimilar to NEULASTA® (pegfilgrastim). Accord BioPharma. July 9, 2026. Accessed July 9, 2026. https://www.accordbiopharma.com/news/fda-approves-ennumo-pegfilgrastim-pccg-accord-biopharmas-second-pegfilgrastim-biosimilar-to-neulasta-pegfilgrastim/