Product Description
Eflapegrastim (ROLVEDON) injection is a long-acting granulocyte colony-stimulating factor (G-CSF) with a novel formulation. Spectrum has received an indication to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia. ROLVEDON is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. (Sourced from: https://investor.sppirx.com/news-releases/news-release-details/spectrum-pharmaceuticals-receives-fda-approval-rolvedontm)
Mechanisms of Action: G-CSF Inhibitor
Novel Mechanism: No
Modality: Peptide/Protein
Route of Administration: Subcutaneous
FDA Designation: None *
Approval Status: Approved
Approved Countries: United States
Approved Indications: Febrile Neutropenia | Neutropenia | Oncology Unspecified | Hematopoietic Stem Cell Transplant | Stem Cell Transplant
Known Adverse Events: Back Pain | Headache | Pain Unspecified | Anemia | Arthralgia | Myalgia | Diarrhea
Company: Spectrum
Company Location: HENDERSON NV 89052
Company CEO: Thomas J. Riga
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: United States
Active Clinical Trial Count: 2
Highest Development Phases
Phase 2: Lymphoma
Phase 1: Breast Cancer|Neutropenia
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| SPI-GCF-202 | P2 |
Recruiting |
Lymphoma |
2027-10-01 |
|
| SPI-GCF-104 | P1 |
Completed |
Breast Cancer|Neutropenia |
2024-07-16 |