Evive Biotech received approval from the U.S. Food and Drug Administration (FDA) on Nov. 16, 2023, for Ryzneuta® (efbemalenograstim alfa-vuxw) injection. It is approved to reduce the risk of infections for adults who develop febrile neutropenia (elevated body temperature and low neutrophil counts) because they are undergoing chemotherapy (chemo) to treat non-myeloid cancers. As a novel leukocyte growth factor (also called granulocyte colony-stimulating factor or G-CSF), Ryzneuta is not interchangeable with any other currently available growth factor product. Its recommended dose is 20mg given as one subcutaneous (SC) injection 24 hours following each chemo treatment and at least two weeks before the next scheduled chemo. Evive and its partner, Acrotech Biopharma, have not released cost or launch plans. Full prescribing information for Ryzneuta is here.
At a Glance
- Brand (Generic) Name: Ryzneuta (efbemalenograstim alfa-vuxw)
- Manufacturer: Evive Biotech/Acrotech Biopharma
- Date Approved: Nov. 16, 2023
- Indication: to decrease the incidence of infection, manifested by febrile neutropenia, in adults who have non-myeloid malignancies and who are receiving myelosuppressive anti-cancer drugs that are associated with a clinically significant incidence of febrile neutropenia
- Dosage Forms Available: Single-dose prefilled syringes containing 20mg
- Launch Date: Not yet available
- Estimated Annual Cost: Not yet available
- Febrile neutropenia, often defined as a body temperature of 101o F or higher and a neutrophil count of 500 cells/mm3 or less, is a common side effect of chemo. The drugs that destroy the cancer cells also destroy some immune cells, making infections more likely and usually more serious among cancer patients receiving chemo.
- In the United States, febrile neutropenia is estimated to affect about 60,000 cancer patients each year.
- Ryzneuta boosts the production of neutrophils to improve immune response and lessen chemo’s adverse effects.
- In two phase III clinical trials, results were similar for patients receiving either Ryzneuta or the present standard of care, Neulasta® (pegfilgrastim).
- Ryzneuta’s side effects, which include anemia, nausea, and low platelet counts, also are similar to those for other growth factors.
- Multiple other growth factors, including several biosimilars, are approved to treat febrile neutropenia in the U.S.
- Ryzneuta is a long-acting drug, but it is not pegylated, a process that enhances solubility and stability for some other growth factor products. As a result, Ryzneuta may have fewer potential side effects.