Efbemalenograstim alfa, sold under the brand name Ryzneuta, is a

medication Medication (also called medicament, medicine, pharmaceutical drug, medicinal product, medicinal drug or simply drug) is a drug used to medical diagnosis, diagnose, cure, treat, or preventive medicine, prevent disease. Drug therapy (pharmaco ...

used to decrease the incidence of infection in

chemotherapy Chemotherapy (often abbreviated chemo, sometimes CTX and CTx) is the type of cancer treatment that uses one or more anti-cancer drugs (list of chemotherapeutic agents, chemotherapeutic agents or alkylating agents) in a standard chemotherapy re ...

-induced

neutropenia Neutropenia is an abnormally low concentration of neutrophils (a type of white blood cell) in the blood. Neutrophils make up the majority of circulating white blood cells and serve as the primary defense against infections by destroying bacteria ...

. It is a leukocyte growth factor. It is given by subcutaneous injection. The most common side effects of efbemalenograstim alfa are nausea, anemia, and thrombocytopenia. Efbemalenograstim alfa is an immunostimulant/colony stimulating factor that belongs to the class of

hematopoietic Haematopoiesis (; ; also hematopoiesis in American English, sometimes h(a)emopoiesis) is the formation of blood cellular components. All cellular blood components are derived from haematopoietic stem cells. In a healthy adult human, roughly ten ...

growth factors (granulocyte colony stimulating factor; G CSF) which increase the production and differentiation of mature and functionally active neutrophils from bone marrow precursor cells. It was approved for medical use in China in May 2023, in the United States in November 2023, and in the European Union in March 2024.

Medical uses

In the US, efbemalenograstim alfa is

indicated In medicine, an indication is a valid reason to use a certain test, medication, procedure, or surgery. There can be multiple indications to use a procedure or medication. An indication can commonly be confused with the term diagnosis. A diagnosis ...

to decrease the incidence of infection, as manifested by febrile neutropenia, in adults with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. In the EU, efbemalenograstim alfa is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in adults treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).

Side effects

Efbemalenograstim alfa can cause fatal splenic rupture, acute respiratory distress syndrome, serious allergic reactions including anaphylaxis, sickle cell crises in patients with sickle cell disorders, glomerulonephritis, thrombocytopenia, capillary leak syndrome, and myelodysplastic syndrome and acute myeloid leukemia in people with breast and lung cancer.

History

The US

Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respo ...

approved efbemalenograstim alfa based on evidence from two main clinical trials, GC-627-04 and GC-627-05, in 515 participants with breast cancer receiving chemotherapy. There was one participant included in the trial from the United States, and 514 participants were included from sites outside of the United States. The trials were conducted at 52 sites in five countries including Hungary, Russia, Ukraine, Bulgaria, and the United States. The same trials (GC-627-04 and GC-627-05) were used to assess efficacy and safety. Efbemalenograstim alfa was evaluated in two main clinical trials that were randomized and controlled. A total of 515 participants were randomized to receive efbemalenograstim alfa or placebo, or Neulasta, after receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia to treat metastatic breast cancer. Both trials evaluated the benefit and side effects of efbemalenograstim alfa in participants. The benefit of efbemalenograstim alfa was based on the mean duration of severe neutropenia seen in participants after receiving either efbemalenograstim alfa or control (placebo or Neulasta).

Society and culture

Legal status

It was approved for medical use in China in May 2023, in the United States in November 2023, and in the European Union in March 2024. In January 2024, the

Committee for Medicinal Products for Human Use The Committee for Medicinal Products for Human Use (CHMP), formerly known as the Committee for Proprietary Medicinal Products (CPMP), is the European Medicines Agency's committee responsible for elaborating the agency's opinions on all issues regar ...

of the

European Medicines Agency The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of pharmaceutical products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products ...

adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Ryzneuta, intended to reduce the duration of neutropenia and the incidence of febrile neutropenia due to chemotherapy. The applicant for this medicinal product is Evive Biotechnology Ireland Limited. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged. Efbemalenograstim alfa was approved for medical use in the European Union in March 2024.

References

External links

* * * {{Authority control Drugs acting on the blood and blood forming organs Growth factors Immunostimulants Recombinant proteins