For non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with…. BLA 761134, held by Evive Biotechnology. Efbemalenograstim Alfa-Vuxw.
As of Nov 13, 2026, BLA 761134 (Ryzneuta), held by Evive Biotechnology, was first approved by FDA on Nov 16, 2023, with 0 approved supplements and 0 published complete response letters.
1. INDICATIONS AND USAGE RYZNEUTA is 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. Limitations of Use RYZNEUTA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. RYZNEUTA is a leukocyte growth factor
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 16, 2023 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ryzneuta20MG/ML · injectable;injection | Efbemalenograstim Alfa-Vuxw | Rx |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
