Rolvedon (eflapegrastim-xnst) is now available 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.

Findings from both trials showed that the primary endpoint of noninferiority in the duration of severe neutropenia between eflapegrastim and pegfilgrastim was met. Additionally, no statistically significant differences in adverse events were observed between eflapegrastim and pegfilgrastim.

Rolvedon is supplied as a single-dose prefilled syringe containing 13.2mg of eflapegrastim-xnst in 0.6mL solution. It is administered subcutaneously by a health care professional.

References

  1. Spectrum Pharmaceuticals announces commercial availability of Rolvedon™ (eflapegrastim-xnst) Injection. News release. October 21, 2022. https://www.businesswire.com/news/home/20221021005060/en/Spectrum-Pharmaceuticals-Announces-Commercial-Availability-of-ROLVEDON%E2%84%A2-eflapegrastim-xnst-Injection
  2. Rolvedon. Package insert. Spectrum Pharmaceuticals, Inc; 2022. Accessed October 21, 2022. https://www.rolvedon.com/pdf/rolvedon-prescribing-information.pdf