FDA Approves Oncology Supportive Care Biosimilar
FDA officials based their approval on the review of data and evidence that demonstrated a close similarity between pegfilgrastim-apgf and its reference product.
The biosimilar pegfilgrastim-apgf (Nyvepria, Pfizer) has been approved by the FDA to decrease occurrences of infection that can occur due to febrile neutropenia in patients with nonmyeloid malignancies who are receiving myelosuppressive anticancer drugs, as such drugs are associated with clinically significant incidence of febrile neutropenia.
Infection can occur in patients with nonmyeloid cancer who receive anticancer medicines, like chemotherapy, due to the medicines’ ability to cause a low white blood cell count. This condition, known as febrile neutropenia, is a common adverse effect (AE) of many chemotherapy treatments, as they lower the body’s ability to defend itself from infections.
Since pegfilgrastim-apgf is a biosimilar to pegfilgrastim, the FDA officials based their approval on the review of data and evidence that demonstrated a close similarity between pegfilgrastim-apgf and its reference product.
“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,” said Ali McBride, PharmD, MS, BCPS, BCOP, Immediate Past President of the Association of Community Cancer Centers, in a press release. “The FDA approval of Nyvepria provides clinicians with an additional long-acting treatment option that can help prevent infections in patients undergoing myelosuppressive chemotherapy.”
Biosimilars are an important treatment method for cancer or as supportive care, as they can both the support the increase of patient access to essential medicines and drive market competition that can lower the cost of care.
Additionally, Pfizer is granting patients access to the Pfizer Oncology Together platform in order to offer support and financial assistance resources that ensure all patients get access to the medication. The platform will guide patients through understanding their coverage for the medication and connect them with financial resources that will be available regardless of their insurance coverage.
The company noted that pegfilgrastim-apgf is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation, and the treatment is contraindicated in patients who have a history of allergic reactions to pegfilgrastim or filgrastim. Other potential AEs include splenic rupture, acute respiratory distress syndrome, serious allergic reactions, glomerulonephritis, leukocytosis, capillary leak syndrome, aortitis, bone pain, and pain in extremities.
FDA Approves Pfizer’s Oncology Supportive Care Biosimilar, NYVEPRIA™ (pegfilgrastim-apgf) [news release]. New York, NY: Pfizer Inc.; June 11, 2020. Accessed June 11, 2020.