Efbemalenograstim Alfa: First Approval

Drugs. 2023 Aug;83(12):1125-1130. doi: 10.1007/s40265-023-01911-7.

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.

Publication types

  • Review

MeSH terms

  • Adult
  • Antineoplastic Agents* / adverse effects
  • China
  • Febrile Neutropenia* / drug therapy
  • Humans
  • Neoplasms* / drug therapy
  • Recombinant Proteins / therapeutic use

Substances

  • Recombinant Proteins
  • Antineoplastic Agents