FDA Approves Eflapegrastim to Decrease Risk of Infection in Patients Receiving Cytotoxic Chemotherapy


The FDA has approved eflapegrastim to treat febrile neutropenia. The agent should be administered 24 hours following cytotoxic chemotherapy. It comes with warnings for fatal splenic rupture, acute respiratory distress syndrome, sickle cell crisis, glomerulonephritis, leukocytosis, thrombocytopenia, and myelodysplastic syndrome.

The FDA has approved eflapegrastim-xnst (Rolvedon) injections to reduce the risk of infection in adults with nonmyeloid malignancies who are receiving anticancer therapies associated with a high risk of febrile neutropenia.1

Two phase 3 trials supported the regulatory decision. The ADVANCE (NCT02643420) and RECOVER (NCT02953340) trials showed that eflapegrastim met the prespecified hypothesis of noninferiority vs pegfilgrastim (Neulasta) in mean duration of severe neutropenia (DSN) with a similar safety profile to pegfilgrastim. Eflapegrastim also demonstrated non-inferiority to pegfilgrastim in the mean DSN across all 4 cycles (P < .0001) in both trials.

Eflapegrastim is a man-made form of granulocyte colony-stimulating factor (G-CSF), which is a substance naturally provided in the body. The drug stimulates the growth of neutrophils, which help strengthen the body’s ability to fight infection. This approval represents the first long-acting G-CSF to be approved in over 20 years, according to a news release.1

The recommended dose for eflapegrastim is 13.2 mg subcutaneously once per chemotherapy cycle. The agent should be given approximately 24 hours past cytotoxic chemotherapy. It should not be administered in the 14 days leading up to chemotherapy nor should it be administered before 24 hours have passed since the chemotherapy infusion.

Eflapegrastim comes in a prefilled syringe which does not bear graduation marks and it intended to deliver the whole contents of the syringe for direct administration.2 There is no natural rubber latex with eflapegrastim. In preparing to administer eflapegrastim, the carton should be removed from refrigeration at least 30 minutes prior to injection to allow it to reach room temperature. It should not be shaken. If a prefilled syringe is left at room temperature for more than 12 hours, is frozen, or is accidently dropped onto a hard surface, it should not be used.

The agent comes with warnings for fatal splenic rupture, acute respiratory distress syndrome, sickle cell crisis, glomerulonephritis, leukocytosis, thrombocytopenia, and myelodysplastic syndrome.

Patients should be monitored for upper left abdominal or shoulder pain, as this may indicate an enlarged spleen of splenic rupture. Similarly, patients should be evaluated for any development of fever, lung infiltrates, or respiratory distress. If respiratory issues occur, the treatment should be discontinued.

If a patient experienced sickle cell crisis, the treatment should be discontinued. In the event of glomerulonephritis, a dose-reduction or interruptions should be considered.

Moreover, complete blood counts and platelet counts should be monitored to ensure the patient is not developing leukocytosis or thrombocytopenia. Providers should also be on the look-out for any indication that a patient is developing either myelodysplastic syndrome or acute myeloid leukemia for patients who are receiving eflapegrastim in conjunction with chemotherapy or radiotherapy.

The agent also comes with a. risk of serious reaction. Patients with a history of serious allergic reactions to human G-CSF such as eflapegrastim, pegfilgrastim or filgrastim product, should not receive eflapegrastim. Any patient who develops a serious allergic reaction will need to permanently discontinue treatment.

The most common any grade adverse events (AE) (≥ 20%) experienced in the phase 3 trials were fatigue, nausea, diarrhea, bone pain, headache, pyrexia, anemia, rash, myalgia, arthralgia, and back pain. A total of 4% of patients receiving eflapegrastim required permanent discontinuation. The AE linked to most permanent discontinuation was rash.


  1. Spectrum Pharmaceuticals receives FDA approval for Rolvedon (eflapegrastim-xnst) injection. News release. Spectrum Pharmaceuticals. September 9, 2022. Accessed September 20, 2022. https://bwnews.pr/3DayQAD
  2. Rolvedon. Prescribing information. Spectrum Pharmaceuticals; 2022. Accessed September 20, 2022. https://bit.ly/3KZLmFb

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