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Rolvedon (EFLAPEGRASTIM)
Rolvedon works by binding to the granulocyte colony-stimulating factor receptor, stimulating the production of white blood cells.
At a glance
| Generic name | EFLAPEGRASTIM |
|---|---|
| Sponsor | Spectrum Pharms |
| Drug class | Leukocyte Growth Factor [EPC] |
| Target | Granulocyte colony-stimulating factor receptor |
| Modality | Recombinant protein |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2022 |
Mechanism of action
Eflapegrastim-xnst is recombinant human granulocyte growth factor that binds to G-CSF receptors on myeloid progenitor cells and neutrophils, triggering signaling pathways that control cell differentiation, proliferation, migration and survival.
Approved indications
- Febrile neutropenia caused by myelosuppressive anti-cancer drugs
Common side effects
- Fatigue
- Nausea
- Diarrhea
- Bone pain
- Headache
- Pyrexia
- Anemia
- Rash
- Myalgia
- Arthralgia
- Back pain
- Decreased appetite
Key clinical trials
- A Study to Evaluate the Safety and Pharmacokinetics of Eflapegrastim in Pediatric Participants With Solid Tumors or Lymphomas and Treated With Myelosuppressive Chemotherapy (PHASE2)
- Open-Label, Phase 1 Study to Evaluate Duration of Severe Neutropenia After Same-Day Dosing of Eflapegrastim in Patients With Breast-Cancer (PHASE1)
- Reducing Neutropenia Incidence With Pegfilgrastim Administration on Day 3 After Chemotherapy (PHASE4)
- Phase 2 Study of SPI-2012 or Pegfilgrastim for the Management of Neutropenia in Participants With Breast Cancer (PHASE2)
- SPI-2012 vs Pegfilgrastim in Management of Neutropenia in Breast Cancer Participants With Docetaxel and Cyclophosphamide (PHASE3)
- SPI-2012 vs Pegfilgrastim in the Management of Neutropenia in Participants With Breast Cancer With Docetaxel and Cyclophosphamide (ADVANCE) (PHASE3)
- Pharmacokinetics of SPI-2012 (Eflapegrastim) in Breast Cancer Patients Receiving Docetaxel and Cyclophosphamide (TC) Chemotherapy (PHASE1)
- Safety and PK of HM10460A (HNK460) in Healthy Adult Japanese and Caucasian Subjects (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Rolvedon CI brief — competitive landscape report
- Rolvedon updates RSS · CI watch RSS
- Spectrum Pharms portfolio CI