Clinical data | |
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Trade names | Rolvedon |
Other names | Eflapegrastim-xnst, HM-10460A, SPI-2012 |
License data | |
Routes of administration | Subcutaneous |
ATC code | |
Legal status | |
Legal status | |
Identifiers | |
CAS Number | |
ChemSpider |
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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]
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 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]
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]
Clinical data | |
---|---|
Trade names | Rolvedon |
Other names | Eflapegrastim-xnst, HM-10460A, SPI-2012 |
License data | |
Routes of administration | Subcutaneous |
ATC code | |
Legal status | |
Legal status | |
Identifiers | |
CAS Number | |
ChemSpider |
|
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]
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 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]
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]