Eflapegrastism-xnst injection (Rolvedon, Spectrum Pharmaceuticals) is indicated to lower the incidence of infection, as demonstrated by febrile neutropenia, in adult patients with non-myeloid malignancies.
The FDA has approved eflapegrastism-xnst injection (Rolvedon, Spectrum Pharmaceuticals) to reduce the incidence of infection, as demonstrated by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia.1
Febrile neutropenia is defined as a condition marked by fever and a lower than normal amount of neutrophils in the blood. Neutrophils are white blood cells that help fight infection and when low, can increase the risk of infection.2
Eflapegrastism-xnst injection is a novel, long-acting granulocyte colony-stimulating factor (G-CSF). It is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.1
“Rolvedon’s approval marks Spectrum’s transformation to a commercial-stage company with the opportunity to compete in a $2 billion dollar market, and offers a unique value proposition,” said Tom Riga, president and chief executive officer, of Spectrum Pharmaceuticals, in a press release. “This approval is a significant milestone for our development team and collaboration with Hanmi Pharmaceutical. On behalf of Spectrum, I would like to thank all of the patients, families, health care providers, and our own team members for bringing this goal to fruition.”1
Eflapegrastism-xnst has a contraindication in patients with a history of serious allergic reactions to eflapegrastism, pegfilgrastism, or filgrastism products, with reactions including anaphylaxis.1
Other warnings and precautions include:1
The most common adverse events (AEs) were fatigue, nausea, diarrhea, bone pain, headache, pyrexia, anemia, rash, myalgia, arthralgia, and back pain. Further, permanent discontinuation due to an AE occurred in 4% of patients who received eflapegrastism-xnst, with this AE being in the form of a rash for 3 patients.1