Eflapegrastim

Eflapegrastim
Clinical data
Trade names	Rolvedon
Other names	Eflapegrastim-xnst, HM-10460A, SPI-2012
License data	US DailyMed: Eflapegrastim;
Routes of; administration	Subcutaneous
ATC code	L03AA19 (WHO) ;
Legal status
Legal status	US: ℞-only;
Identifiers
CAS Number	1384099-30-2;
ChemSpider	None;
UNII	UT99UG9QJX;
KEGG	D11188;

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]

Medical uses

Eflapegrastim 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 clinically significant incidence of febrile neutropenia.^[1]

Its efficacy has been shown to be non-inferior to pegfilgrastim.^[1]

History

The US Food and Drug Administration (FDA) approved eflapegrastim based on evidence from two clinical trials of 643 participants with breast cancer treated with anti-cancer drugs that suppress the bone marrow from producing blood cells.^[4] The trials were conducted at 119 sites in six countries in the United States, Canada, South-Korea, Hungary, Poland, and India.^[4] Eflapegrastim was evaluated in two clinical trials of 643 participants with breast cancer receiving anticancer treatment that is known to suppress the growth of blood-forming cells (red blood cells, white blood cells, and platelets) in the bone marrow.^[4] In both trials, participants were randomly assigned to either receive eflapegrastim or pegfilgrastim under the skin (subcutaneously) approximately 24 hours after anticancer treatment.^[4] Participants in both groups were evaluated and compared for the duration of severe neutropenia (a condition with lower-than-normal levels of neutrophils in the blood) during the first cycle of anticancer therapy.^[4]

References

^ ^a ^b ^c ^d ^e ^f "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.
^ ^a ^b ^c ^d ^e ^f "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.

External links

Clinical trial number NCT02643420 for "SPI-2012 vs Pegfilgrastim in the Management of Neutropenia in Participants With Breast Cancer With Docetaxel and Cyclophosphamide (ADVANCE) (ADVANCE)" at ClinicalTrials.gov
Clinical trial number NCT02953340 for "SPI-2012 vs Pegfilgrastim in Management of Neutropenia in Breast Cancer Participants With Docetaxel and Cyclophosphamide" at ClinicalTrials.gov