{"entity":{"id":"eflapegrastim","kind":"drug","name":"Eflapegrastim","aka":["Eflapegrastim-xnst","SPI-2012"],"tldr":"Eflapegrastim is a once-per-cycle white cell growth factor approved in the United States in 2022 to prevent infections when chemotherapy for solid tumours knocks down neutrophils, an alternative to pegfilgrastim.","summary":"Eflapegrastim uses Hanmi's long-acting carrier technology to extend the life of G-CSF. The FDA approved it in September 2022 to decrease the incidence of febrile neutropenia in adults with non-myeloid malignancies receiving myelosuppressive chemotherapy, after the ADVANCE and RECOVER trials showed it was non-inferior to pegfilgrastim for the duration of severe neutropenia in breast cancer patients on docetaxel and cyclophosphamide. It is given about 24 hours after chemotherapy; bone pain and nausea are the common side effects. It was developed by Spectrum Pharmaceuticals and is now marketed by Assertio.","status":"approved","asOf":"2026-09-08","wikipedia":"https://en.wikipedia.org/wiki/Eflapegrastim","links":[{"label":"Drugs@FDA BLA761148","url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761148"},{"label":"Label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=eflapegrastim"},{"label":"Wikipedia","url":"https://en.wikipedia.org/wiki/Eflapegrastim"}],"tags":["gap-fill","chembl-universe"],"related":[],"cancers":["breast-hr-positive"],"sections":[],"technologies":["cytokine-therapy"],"targets":["csf3r"],"drugs":["pegfilgrastim"],"companies":["spectrum-pharmaceuticals"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"notes":[],"brand":"Rolvedon","modality":"Long-acting G-CSF fused to an antibody Fc fragment, once per chemotherapy cycle","mechanism":"G-CSF joined to an IgG4 Fc fragment through a polyethylene glycol linker, so it is cleared slowly and keeps stimulating neutrophil production for the whole cycle.","approvals":[{"region":"US","year":2022,"indication":"To decrease the incidence of febrile neutropenia in adults with non-myeloid malignancies receiving myelosuppressive chemotherapy"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/eflapegrastim/","neighbours":{"cancer":[{"id":"breast-hr-positive","kind":"cancer","name":"HR-positive / HER2-negative breast cancer","route":"/cancers/breast-hr-positive/"}],"technology":[{"id":"cytokine-therapy","kind":"technology","name":"Cytokines & engineered cytokines","route":"/technologies/cytokine-therapy/"}],"target":[{"id":"csf3r","kind":"target","name":"G-CSF receptor (CSF3R)","route":"/targets/csf3r/"}],"drug":[{"id":"pegfilgrastim","kind":"drug","name":"Pegfilgrastim","route":"/drugs/pegfilgrastim/"}],"company":[{"id":"spectrum-pharmaceuticals","kind":"company","name":"Spectrum Pharmaceuticals","route":"/companies/spectrum-pharmaceuticals/"}],"trial":[{"id":"nct04570423","kind":"trial","name":"A Study to Evaluate the Safety and Pharmacokinetics of Eflapegrastim in Pediatric Participants With Solid Tumors or Lymphomas and Treated With Myelosuppressive Chemotherapy","route":"/trials/nct04570423/"}]}}