Rolvedon From Spectrum Pharmaceuticals, Inc

The FDA has approved eflapegrastim-xnst subcutaneous injection (Rolvedon) from Spectrum Pharmaceuticals, Inc, to reduce infections related to febrile neutropenia in adults with nonmyeloid malignant tumors who are being treated with certain anticancer drugs. The approval carries the limitation that Rolvedon is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.¹

Pharmacology and Pharmacokinetics

Rolvedon is a recombinant human granulocyte growth factor. It binds to granulocyte colony-stimulating factor (G-CSF) receptors on myeloid progenitor cells and neutrophils to trigger signaling pathways that control cell differentiation, migration, proliferation, and survival, resulting in elevated neutrophil counts in both healthy patients and patientswith cancer. Rolvedon displays a median time to maximum plasma concentration of 25 hours, with a range of 6 to 144 hours. Its mean elimination half-life is 36.4 hours, with a range of 16.1 to 115 hours. The metabolism of Rolvedon is thought to be by endogenous degradation after receptor-mediated internalization by cells bearing the G-CSF receptor.¹

Dosage and Administration

The recommended dose of Rolvedon is 13.2 mg subcutaneously once per chemotherapy cycle, with administration occurring approximately 24 hours after the patient receives cytotoxic chemotherapy. Rolvedon should not be given within 14 days before cytotoxic chemotherapy to 24 hours after cytotoxic chemotherapy. Rolvedon is supplied in a single-dose, prefilled syringe containing 13.2 mg/0.6 mL as a clear, colorless, preservative-free solution.¹

Clinical Trials

The efficacy of Rolvedon to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignant tumors receiving myelosuppressive anticancer drugs was evaluated in 2 active-controlled, noninferiority, open-label, randomized studies, ADVANCE (NCT02643420) and RECOVER (NCT02953340). The studies consisted of a total of 643 participants with early-stage breast cancer who received docetaxel 75 mg/m2 and cyclophosphamide 600 mg/m² (TC) intravenously every 21 days on the first day of each cycle for up to 4 cycles. Study participants were randomly assigned 1:1 to receive either Rolvedon 13.2 mg subcutaneously or pegfilgrastim 6 mg subcutaneously on day 2 of each cycle after TC chemotherapy. Efficacy for both trials was based on the duration of severe neutropenia in cycle 1, and both studies found Rolvedon to be noninferior to pegfilgrastim. Additionally, Rolvedon was found to be noninferior to pegfilgrastim in the mean duration of severe neutropenia in all 4 cycles in both studies.^1,2

Contraditions, Warnings, and Precautions

The use of Rolvedon is contraindicated in patients with a history of serious allergic reactions to human G-CSFs, such as eflapegrastim, filgrastim, or pegfilgrastim.

Because splenic rupture, including fatal cases, can occur after the administration of recombinant human granulocyte colony stimulating factor (rhG-CSF) products, patients experiencing left upper abdominal pain or shoulder pain should be evaluated for an enlarged spleen or splenic rupture. Patients with fever, lung infiltrates, or respiratory distress should be evaluated for acute respiratory distress syndrome, which can occur in patients using rhG-CSF products. If serious allergic reactions occur, such as anaphylaxis, the medication should be permanently discontinued.

Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders who are using rhG-CSF products. Glomerulonephritis has occurred in patients receiving rhG-CSF products and may require dose interruption or reduction. Complete blood count and platelet count should be monitored during treatment with Rolvedon. Monitor patients with breast and lung cancer who are using Rolvedon with chemotherapy and/or radiotherapy for signs and symptoms of myelodysplastic syndrome and acute myeloid leukemia.

The most common adverse reactionsare anemia, arthralgia, back pain, bone pain, diarrhea, fatigue, headaches, myalgia, nausea, pyrexia, and rashes.¹

References

1. Rolvedon. Prescribing information. Spectrum Pharmaceuticals, Inc. 2022. Accessed November 29, 2022. https://www.rolvedon.com/pdf/rolvedon-prescribing-information.pdf

2. Spectrum Pharmaceuticals receives FDA approval for Rolvedon (eflapegrastim-xnst) injection. News release. Spectrum Pharmaceuticals. September 9, 2022. Accessed November 29, 2022. https://investor.sppirx.com/news-releases/news-release-details/spectrum-pharmaceuticals-receives-fda-approval-rolvedontm

About the Author

Monica Holmberg, PharmD, BCPS, is a pharmacist in Phoenix, Arizona, and a Pharmacy Times® contributor.