| Clinical data | |
|---|---|
| Trade names | Ryzneuta |
| Other names | F-627, efbemalenograstim alfa-vuxw, benegrastim |
| AHFS/Drugs.com | Ryzneuta |
| License data | |
| Routes of administration | Subcutaneous |
| Drug class | Immunological agent |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| UNII | |
| KEGG | |
Efbemalenograstim alfa, sold under the brand name Ryzneuta, is a medication used to decrease the incidence of infection in chemotherapy-induced neutropenia.[1] It is a leukocyte growth factor.[1] It is given by subcutaneous injection.[1]
It was approved for medical use in China in May 2023,[2] and the United States in November 2023.[1] [3]
Medical uses
Efbemalenograstim alfa is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adults with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.[4]
References
- 1 2 3 4 5 "Ryzneuta- efbemalenograstim alfa-vuxw injection". DailyMed. 23 November 2023. Archived from the original on 12 December 2023. Retrieved 12 December 2023.
- 1 2 Blair HA (August 2023). "Efbemalenograstim Alfa: First Approval". Drugs. 83 (12): 1125–1130. doi:10.1007/s40265-023-01911-7. PMID 37368138. S2CID 259260831. Archived from the original on 20 November 2023. Retrieved 18 November 2023.
- ↑ "Novel Drug Approvals for 2023". U.S. Food and Drug Administration (FDA). 17 November 2023. Archived from the original on 21 January 2023. Retrieved 20 November 2023.
- ↑ Yanoff L (16 November 2023). "Ryzneuta (efbemalenograstim alfa-vuxw) injection" (PDF). Biologics license application (BLA) approval letter. Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration. Archived from the original (PDF) on 17 November 2023.
This article incorporates text from this source, which is in the public domain.
External links
- "Efbemalenograstim alfa (Code C102854)". NCI Thesaurus. 25 September 2023.
- Clinical trial number NCT02872103 for "Placebo-controlled Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy" at ClinicalTrials.gov
- Clinical trial number NCT03252431 for "Neulasta-controlled Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy" at ClinicalTrials.gov
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