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Synonyms: eflapegrastim-xnst | HM-10460A | HM10460A | rolontis | Rolvedon® | SPI-2012 | SPI2012
eflapegrastim is an approved drug (FDA (2022))
Compound class:
Peptide or derivative
Comment: Eflapegrastim (SPI-2012) is a long-acting, human granulocyte colony-stimulating factor (G-CSF) recombinant peptide. Structurally it consists of a recombinant G-CSF (1-174) peptide monomer and an IgG4 Fc dimer, that are joined by a PEG-derived linker molecule. G-CSF stimulates neutrophil progenitor proliferation and differentiation, a molecular mechanism that is exploited to reduce the incidence and severity of chemotherapy-induced neutropenia. The Fc fragment increases the drug's half-life (reduces clearance) and overall efficacy by improving uptake into the bone marrow via binding to Fc receptors on the endothelial cells [1].
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| No information available. |
Summary of Clinical Use  |
| Eflapegrastim was granted full FDA approval in September 2022. It is intended to reduce the frequency of infections in patients who are receiving myelosuppressive anti-cancer drugs. Eflapegrastim is administered by subcutaneous injection once per chemotherapy cycle |
| Clinical Trials | |||||
| Clinical Trial ID | Title | Type | Source | Comment | References |
| NCT02643420 | SPI-2012 vs Pegfilgrastim in the Management of Neutropenia in Participants With Breast Cancer With Docetaxel and Cyclophosphamide (ADVANCE) | Phase 3 Interventional | Spectrum Pharmaceuticals, Inc | 2 | |
