1. Academic Validation
  2. Efbemalenograstim Alfa: First Approval

Efbemalenograstim Alfa: First Approval

  • Drugs. 2023 Aug;83(12):1125-1130. doi: 10.1007/s40265-023-01911-7.
Hannah A Blair 1
Affiliations

Affiliation

  • 1 Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. dru@adis.com.
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.

Figures
Products