Eflapegrastim, sold under the brand name Rolvedon among others, is a long-acting G-CSF analog developed by Hanmi Pharmaceutical and licensed to Spectrum Pharmaceuticals.[2] Eflapegrastim is a leukocyte growth factor.[1] It is used to reduce the risk of febrile neutropenia in people with non-myeloid malignancies receiving myelosuppressive anti-cancer agents.[1][3]
The most common side effects are fatigue, nausea, diarrhea, bone pain, headache, fever, anemia, rash, myalgia, arthralgia, and back pain.[4]
Eflapegrastim was approved for medical use in the United States in September 2022.[1][5][6]
^ abcd"Rolvedon- eflapegrastim-xnst injection, solution". DailyMed. 23 September 2022. Archived from the original on 16 October 2022. Retrieved 16 October 2022.
^pharmaceutical h. "Pipeline - R&D". Hanmi Pharmaceutical. Archived from the original on 2 February 2017. Retrieved 23 January 2017.
^Blayney DW, Schwartzberg L (September 2022). "Chemotherapy-induced neutropenia and emerging agents for prevention and treatment: A review". Cancer Treatment Reviews. 109: 102427. doi:10.1016/j.ctrv.2022.102427. PMID 35785754. S2CID 249936800.
^"Drug Trials Snapshots: Rolvedon". U.S. Food and Drug Administration (FDA). 9 September 2022. Retrieved 3 December 2023. This article incorporates text from this source, which is in the public domain.
^"Rolvedon: FDA-Approved Drugs". U.S. Food and Drug Administration (FDA). Archived from the original on 19 September 2022. Retrieved 18 September 2022.
^"Spectrum Pharmaceuticals Receives FDA Approval for Rolvedon (eflapegrastim-xnst) Injection". Business Wire (Press release). 9 September 2022. Archived from the original on 9 September 2022. Retrieved 18 September 2022.
Eflapegrastim, sold under the brand name Rolvedon among others, is a long-acting G-CSF analog developed by Hanmi Pharmaceutical and licensed to Spectrum...
assets. As of 2023, Spectrum has one FDA approved drug (ROLVEDON™ (eflapegrastim) is also formerly known as Rolontis) and one drug in advanced development...