Drug updated on 10/21/2024
| Dosage Form | Injection (subcutaneous; 20 mg/mL) |
| Drug Class | Leukocyte growth factors |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia
Latest News
Summary
- This summary is based on the review of one randomized controlled trial(s). [1]
- Efbemalenograstim alfa significantly reduced the mean duration of severe neutropenia (DSN) in Cycle 1 to 1.3 days compared to 3.9 days for the placebo, with a 95% Confidence Interval (CI) for the difference between 2.3 and 3.4 days, indicating superiority over placebo.
- The incidence of febrile neutropenia (FN) in Cycle 1 was 4.8% for efbemalenograstim alfa versus 25.6% for placebo, with a statistically significant difference (p = 0.0016).
- The requirement for intravenous antibiotics was significantly lower in the efbemalenograstim alfa group at 3.6%, compared to 17.9% in the placebo group (p = 0.0119), indicating effective prevention of complications related to chemotherapy.
- There is no safety information available in the reviewed documents.
- There is no population types or subgroups information available in the reviewed documents.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Ryzneuta (efbemalenograstim alfa-vuxw) Prescribing Information. | 2023 | Evive Biotechnology PTE. LTD., Singapore |
Randomized Controlled Trials
| Document Title | Sex Distribution | Year | Source |
|---|---|---|---|
| Efbemalenograstim alfa, an Fc fusion protein, long-acting granulocyte-colony stimulating factor for reducing the risk of febrile neutropenia following chemotherapy: results of a phase III trial | 122Subjects F: 100% M: 0% | 2023 | Supportive Care in Cancer |
Sex Distribution:
F:100%
M:0%
122Subjects
Year:
2023
Source:Supportive Care in Cancer