Eflapegrastim

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Eflapegrastim
Clinical data
Trade names Rolvedon
Other namesEflapegrastim-xnst, HM-10460A, SPI-2012
License data
Routes of
administration
Subcutaneous
ATC code
Legal status
Legal status
Identifiers
CAS Number
ChemSpider
  • None
UNII
KEGG

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]

Contents

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]

Related Research Articles

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Neutropenia is an abnormally low concentration of neutrophils in the blood. Neutrophils make up the majority of circulating white blood cells and serve as the primary defense against infections by destroying bacteria, bacterial fragments and immunoglobulin-bound viruses in the blood. People with neutropenia are more susceptible to bacterial infections and, without prompt medical attention, the condition may become life-threatening.

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Pegfilgrastim, sold under the brand name Neulasta among others, is a PEGylated form of the recombinant human granulocyte colony-stimulating factor (GCSF) analog filgrastim. It serves to stimulate the production of white blood cells (neutrophils). Pegfilgrastim was developed by Amgen.

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Ribonucleotide reductase inhibitors are a family of anti-cancer drugs that interfere with the growth of tumor cells by blocking the formation of deoxyribonucleotides.

Spectrum Pharmaceuticals is an American biopharmaceutical company located in Boston, MA. It develops and markets drugs for treatments in hematology and oncology.

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Trilaciclib, sold under the brand name Cosela, is a medication used to reduce the frequency of chemotherapy-induced bone marrow suppression.

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Decitabine/cedazuridine, sold under the brand name Inqovi among others, is a fixed-dose combination anticancer medication used for the treatment of adults with myelodysplastic syndromes and chronic myelomonocytic leukemia (CMML). It is a combination of decitabine, a nucleoside metabolic inhibitor, and cedazuridine, a cytidine deaminase inhibitor.

Lipegfilgrastim, sold under the brand name Lonquex, is a medication used to reduce the duration of neutropenia and the incidence of febrile neutropenia in adults. It is given by injection under the skin in the abdomen, upper arm or thigh.

Efbemalenograstim alfa, sold under the brand name Ryzneuta, is a medication used to decrease the incidence of infection in chemotherapy-induced neutropenia. It is a leukocyte growth factor. It is given by subcutaneous injection.

References

  1. 1 2 3 4 5 6 "Rolvedon- eflapegrastim-xnst injection, solution". DailyMed. 23 September 2022. Archived from the original on 16 October 2022. Retrieved 16 October 2022.
  2. pharmaceutical h. "Pipeline - R&D". Hanmi Pharmaceutical. Archived from the original on 2 February 2017. Retrieved 23 January 2017.
  3. 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.
  4. 1 2 3 4 5 6 "Drug Trials Snapshots: Rolvedon". U.S. Food and Drug Administration (FDA). 9 September 2022. Retrieved 3 December 2023.PD-icon.svg This article incorporates text from this source, which is in the public domain .
  5. "Rolvedon: FDA-Approved Drugs". U.S. Food and Drug Administration (FDA). Archived from the original on 19 September 2022. Retrieved 18 September 2022.
  6. "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.