# Eflapegrastim

Source: https://onco.cc/drugs/eflapegrastim/  
OnCo record `eflapegrastim` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Eflapegrastim is a once-per-cycle white cell growth factor approved in the United States in 2022 to prevent infections when chemotherapy for solid tumours knocks down neutrophils, an alternative to pegfilgrastim.

## Summary

Eflapegrastim uses Hanmi's long-acting carrier technology to extend the life of G-CSF. The FDA approved it in September 2022 to decrease the incidence of febrile neutropenia in adults with non-myeloid malignancies receiving myelosuppressive chemotherapy, after the ADVANCE and RECOVER trials showed it was non-inferior to pegfilgrastim for the duration of severe neutropenia in breast cancer patients on docetaxel and cyclophosphamide. It is given about 24 hours after chemotherapy; bone pain and nausea are the common side effects. It was developed by Spectrum Pharmaceuticals and is now marketed by Assertio.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-08
- Also known as: Eflapegrastim-xnst; SPI-2012
- Tags: gap-fill; chembl-universe
- Brand: Rolvedon
- Modality: Long-acting G-CSF fused to an antibody Fc fragment, once per chemotherapy cycle
- Mechanism: G-CSF joined to an IgG4 Fc fragment through a polyethylene glycol linker, so it is cleared slowly and keeps stimulating neutrophil production for the whole cycle.
- Approvals: US 2022: To decrease the incidence of febrile neutropenia in adults with non-myeloid malignancies receiving myelosuppressive chemotherapy

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Eflapegrastim
- Drugs@FDA BLA761148: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761148
- Label (DailyMed): https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=eflapegrastim
- Wikipedia: https://en.wikipedia.org/wiki/Eflapegrastim

## Connected records

- cancers: [HR-positive / HER2-negative breast cancer](https://onco.cc/cancers/breast-hr-positive/)
- technologies: [Cytokines & engineered cytokines](https://onco.cc/technologies/cytokine-therapy/)
- targets: [G-CSF receptor (CSF3R)](https://onco.cc/targets/csf3r/)
- drugs: [Pegfilgrastim](https://onco.cc/drugs/pegfilgrastim/)
- companies: [Spectrum Pharmaceuticals](https://onco.cc/companies/spectrum-pharmaceuticals/)
- trials: [A Study to Evaluate the Safety and Pharmacokinetics of Eflapegrastim in Pediatric Participants With Solid Tumors or Lymphomas and Treated With Myelosuppressive Chemotherapy](https://onco.cc/trials/nct04570423/)

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JSON: https://onco.cc/api/v1/entities/eflapegrastim.json