Efbemalenograstim Alfa: First Approval

Link to article at PubMed

Drugs. 2023 Jun 27. doi: 10.1007/s40265-023-01911-7. Online ahead of print.

ABSTRACT

Efbemalenograstim alfa (Ryzneuta®) is a subcutaneously administered recombinant fusion protein that is being developed by Evive Biotech for the management of chemotherapy-induced neutropenia. On 6 May 2023, efbemalenograstim alfa was approved in China for reducing the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignant tumours who are treated with myelosuppressive anticancer drugs that are prone to cause febrile neutropenia. Efbemalenograstim alfa is under regulatory review for the management of chemotherapy-induced neutropenia in the EU and the USA. This article summarizes the milestones in the development of efbemalenograstim alfa leading to this first approval for the management of chemotherapy-induced neutropenia.

PMID:37368138 | DOI:10.1007/s40265-023-01911-7

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