The FDA has approved pegfilgrastim-pccg, a pegfilgrastim biosimilar, to decrease the incidence of infection in non-myeloid malignancies.
The FDA has approved pegfilgrastim-pccg (Ennumo), a biosimilar referencing pegfilgrastim (Neulasta), to decrease the incidence of infections, as manifested by febrile neutropenia, in adult and pediatric patients with non-myeloid malignancies who are receiving myelosuppressive anticancer treatments that are associated with clinically significant incidences of febrile neutropenia.1
The biosimilar is approved for all of the current pegfilgrastim indications, which also include increasing survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome).
“Every FDA approval marks a step forward in our mission to expand patient access to high-quality, affordable biologic therapies,” Chrys Kokino, president of Accord North America, stated in a news release.“We are proud that we have and will continue to increase patient access to these critically important medicines.”
The FDA previously approved multiple biosimilars referencing pegfilgrastim to decrease the incidence of infection as manifested by febrile neutropenia in patients with non-myeloid malignancies receiving anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia, including an autoinjector formulation of
The on-body injector delivery formulation of pegfilgrastim-cbqv also received
Pegfilgrastim-pccg Biosimilar Approved: Highlights
Notably, in patients with breast or lung cancer, myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML) have been associated with the use of pegfilgrastim products when received alongside chemotherapy or radiotherapy.1 For these patients, monitoring signs of MDS or AML is suggested.
Pegfilgrastim-pccg has a contraindication for patients with a history of serious hypersensitivity reactions, including anaphylaxis, to pegfilgrastim or filgrastim products. Splenic ruptures, which can be fatal, can be experienced by patients who receive pegfilgrastim treatments, and if a patient is experiencing left upper abdominal pain or shoulder pain, it is suggested that they be evaluated for a splenic rupture or enlarged spleen.
Glomerulonephritis, leukocytosis, and thrombocytopenia can all occur during treatment with pegfilgrastim. Notably, glomerulonephritis is usually resolved in patients after receiving a reduced dose of pegfilgrastim, interrupting treatment with this agent, or discontinuing treatment with this agent. Regarding leukocytosis, white blood cell (WBC) counts of 100 x 109/L or greater have occurred in patients who have received pegfilgrastim products, and monitoring of WBC counts throughout treatment is recommended. In terms of thrombocytopenia, platelet counts are recommended to be monitored during treatment with pegfilgrastim products.
Acute respiratory distress syndrome (ARDS) has also been observed in patients who receive treatment with pegfilgrastim products. It is suggested that patients with ARDS discontinue pegfilgrastim-pccg treatment. Additionally, patients who develop fever, lung infiltrates, or respiratory distress during treatment with pegfilgrastim-pccg should be evaluated for ARDS.
Capillary leak syndrome (defined by the presence of hypotension, hypoalbuminemia, edema, or hemoconcentration) has been reported following the administration of G-CSF, including pegfilgrastim products. The frequency and severity of these events vary but can be life threatening. It is recommended that patients who develop capillary leak syndrome symptoms are closely monitored and receive standard symptomatic treatment.
Notably, all approved pegfilgrastim biosimilars are contraindicated in patients who have a history of serious allergic reactions pegfilgrastim or pegfilgrastim products.1,2,3,4,5
