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| Trade names | Rolvedon |
| Other names | Eflapegrastim-xnst, HM-10460A, SPI-2012 |
| License data | |
| Routes of administration | Subcutaneous |
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Eflapegrastim, sold under the brand nameRolvedon among others, is a long-actingG-CSF analog developed byHanmi Pharmaceutical and licensed toSpectrum Pharmaceuticals.[2] Eflapegrastim is a leukocyte growth factor.[1] It is used to reduce the risk offebrile neutropenia in people with non-myeloidmalignancies receivingmyelosuppressive 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]
Eflapegrastim isindicated 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 topegfilgrastim.[1]
The USFood 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]
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