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Febrile Neutropenia: FDA Approves Pegfilgrastim Biosimilar

The FDA has now approved pegfilgrastim-apgf (NyvepriaTM, Pfizer), a biosimilar of pegfilgrastim (Neulasta®, Amgen), for the prevention of febrile neutropenia in patients receiving myelosuppressive treatment for non-myeloid cancers.

For patients with non-myeloid malignancies, chemotherapy and other anti-cancer medicines can often result in neutropenia, a condition involving an abnormally low number of neutrophils––a type of white blood cell––which increases the chance of life-threatening infection. Febrile neutropenia is the development of fever, often accompanied by other signs of infection, in a patient with neutropenia. Pegfilgrastim-apgf helps to prevent infection in patients with non-myeloid cancers receiving myelosuppressive agents associated with a significant risk of febrile neutropenia.

"Chemotherapy-induced febrile neutropenia is a relatively common and severe side effect of some cancer treatments that could cause significant complications and can result in the alteration of treatment regimens," commented Ali McBride, PharmD, MS, BCPS, BCOP, Immediate Past President of the Association of Community Cancer Centers (ACCC), in a press release. "The FDA approval of [pegfilgrastim-apgf] provides clinicians with an additional long-acting treatment option that can help prevent infections in patients undergoing myelosuppressive chemotherapy."

The approval of pegfilgrastim-apgf was based on a review of a comprehensive data package and the sum of evidence indicating a high degree of similarity to pegfilgrastim, the reference product.

The most common adverse reactions with pegfilgrastim-apgf are bone pain and pain in the extremities. Serious allergic reactions, including anaphylaxis, have occurred in patients receiving pegfilgrastim products; pegfilgrastim-apgf is contraindicated in patients who have experienced a serious allergic reaction to these products. Other possible serious adverse events include splenic rupture, including fatal cases; acute respiratory distress syndrome (ARDS); glomerulonephritis; leukocytosis; capillary leak syndrome (CLS); and aortitis. Pegfilgrastim-apgf can also cause severe and sometimes fatal sickle cell crises in patients with sickle cell disorders. Increased hematopoietic activity of the bone marrow in response to growth factor therapy can result in transient positive changes in bone imaging; this should be accounted for in the interpretation of imaging results.

Based on data from tumor cell lines, the possibility that pegfilgrastim products act as a growth factor for any tumor type cannot be excluded.

The recommended dosage is 6 mg administered subcutaneously once per chemotherapy cycle. Pegfilgrastim-apgf should not be administered between 14 days before and 24 hours after administration of cytotoxic chemotherapy. Weight-based dosing is necessary for pediatric patients weighing less than 45 kg.

For More Information

Pfizer (2020). FDA approves Pfizer's oncology supportive care biosimilar, NyvepriaTM (pegfilgrastim-apgf). Available at: https://investors.pfizer.com/investor-news/press-release-details/2020/FDA-Approves-Pfizers-Oncology-Supportive-Care-Biosimilar-NYVEPRIA-pegfilgrastim-apgf/default.aspx

NyvepriaTM (pegfilgrastim-apgf) prescribing information (2020). Pfizer. Available at: http://labeling.pfizer.com/ShowLabeling.aspx?id=13622

Image credit: US Food and Drug Administration


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