{"entity":{"id":"efbemalenograstim-alfa","kind":"drug","name":"Efbemalenograstim alfa","aka":["F-627"],"tldr":"Efbemalenograstim alfa (Ryzneuta) is a once-per-cycle white cell booster, an alternative to pegfilgrastim, that reduces the risk of febrile infections after chemotherapy.","summary":"Efbemalenograstim alfa was approved by the FDA in November 2023 to decrease the incidence of infection manifested by febrile neutropenia in adults with non-myeloid malignancies receiving myelosuppressive chemotherapy, and by the European Commission in March 2024 for reduction of the duration of neutropenia and incidence of febrile neutropenia after cytotoxic chemotherapy (excluding CML and MDS). Two phase 3 trials in breast cancer patients receiving docetaxel-cyclophosphamide showed a duration of severe neutropenia comparable to pegfilgrastim (GC-627-04) and superior to placebo (GC-627-05). Unlike pegylated G-CSF it uses Fc fusion rather than PEG for half-life extension. Bone pain, nausea and thrombocytopenia are the common adverse effects; it is not indicated for stem cell mobilisation.","status":"approved","asOf":"2026-09-10","wikipedia":"https://en.wikipedia.org/wiki/Efbemalenograstim_alfa","links":[{"label":"EPAR (EMA)","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/ryzneuta"},{"label":"US label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=efbemalenograstim"}],"tags":["ema-list","supportive"],"related":["pegfilgrastim","filgrastim"],"cancers":[],"sections":[],"technologies":["g-csf-growth-factors"],"targets":[],"drugs":[],"companies":["evive-biotech"],"institutions":[],"pathways":[],"terms":[],"trials":["nct03252431","nct04174599","nct02872103"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Ryzneuta","modality":"Long-acting recombinant G-CSF dimer (Fc fusion)","supportive":true,"mechanism":"Two G-CSF molecules fused to a human IgG2 Fc fragment; Fc-mediated recycling prolongs the half-life so that a single dose per chemotherapy cycle stimulates neutrophil production and release.","approvals":[{"region":"US","year":2023,"indication":"Decrease in febrile neutropenia in adults with non-myeloid malignancies on myelosuppressive chemotherapy"},{"region":"EU","year":2024,"indication":"Reduction in duration of neutropenia and febrile neutropenia after cytotoxic chemotherapy in adults (excluding CML and MDS)"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/efbemalenograstim-alfa/","neighbours":{"drug":[{"id":"filgrastim","kind":"drug","name":"Filgrastim (G-CSF)","route":"/drugs/filgrastim/"},{"id":"pegfilgrastim","kind":"drug","name":"Pegfilgrastim","route":"/drugs/pegfilgrastim/"}],"technology":[{"id":"g-csf-growth-factors","kind":"technology","name":"Growth factors: G-CSF and febrile neutropenia prevention","route":"/technologies/g-csf-growth-factors/"}],"company":[{"id":"evive-biotech","kind":"company","name":"Evive Biotech","route":"/companies/evive-biotech/"}],"trial":[{"id":"nct03252431","kind":"trial","name":"Neulasta-controlled Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy","route":"/trials/nct03252431/"},{"id":"nct02872103","kind":"trial","name":"Placebo-controlled Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy","route":"/trials/nct02872103/"},{"id":"nct04174599","kind":"trial","name":"Study to Compare the Efficacy and Safety of F-627 and GRAN®","route":"/trials/nct04174599/"}]}}