The Food and Drug Administration (FDA) has approved Rolvedon™ (eflapegrastim-xnst) to decrease the incidence of infection, as manifested by febrile neutropenia, in adults with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with clinically significant incidence of febrile neutropenia.
Rolvedon is a long-acting granulocyte colony-stimulating factor (G-CSF) comprised of 2 protein components, an analogue of G-CSF and an Fc antibody fragment. The approval was based on data from two phase 3 trials, ADVANCE (ClinicalTrials.gov Identifier: NCT02643420) and RECOVER (ClinicalTrials.gov Identifier: NCT02953340), which evaluated the safety and efficacy of eflapegrastim in 643 early-stage breast cancer patients who had neutropenia due to myelosuppressive cytotoxic chemotherapy.
Patients were randomly assigned 1:1 to receive a fixed dose of eflapegrastim or pegfilgrastim subcutaneously on day 2 of each cycle after chemotherapy.
Findings from both trials showed that the primary endpoint of noninferiority in the duration of severe neutropenia between eflapegrastim and pegfilgrastim was met in cycle 1. Treatment with eflapegrastim was also found to be noninferior to pegfilgrastim in the mean duration of severe neutropenia across all 4 cycles in both trials (P <.0001).
As for safety, there were no statistically significant differences in adverse events observed between eflapegrastim and pegfilgrastim. The most common adverse reactions reported with eflapegrastim were fatigue, nausea, diarrhea, bone pain, headache, pyrexia, anemia, rash, myalgia, arthralgia, and back pain.
Rolvedon is supplied as a single-dose prefilled syringe containing 13.2mg of eflapegrastim-xnst in 0.6mL solution. The product is expected to be available in the fourth quarter of 2022.
- Spectrum Pharmaceuticals receives FDA approval for Rolvedon™ (eflapegrastim-xnst) injection. News release. Spectrum Pharmaceuticals, Inc. September 9, 2022. Accessed September 12, 2022. https://www.businesswire.com/news/home/20220909005522/en/Spectrum-Pharmaceuticals-Receives-FDA-Approval-for-ROLVEDON%E2%84%A2-eflapegrastim-xnst-Injection
- Rolvedon. Package insert. Spectrum Pharmaceuticals, Inc; 2022. Accessed September 12, 2022. https://www.rolvedon.com/pdf/rolvedon-prescribing-information.pdf