FDA OKs Pegfilgrastim Biosimilar to Decrease Chemo-Associated Febrile Neutropenia

A comprehensive analytical data package and pharmacokinetic, pharmacodynamic, and immunogenicity study has led the FDA to approve the pegfilgrastim biosimilar pegfilgrastim-cbqv for patients with cancer.

The FDA has granted approval to pegfilgrastim-cbqv (Udencya), a pegfilgrastim biosimilar, in order to decrease chemotherapy-associated febrile neutropenia in patients with cancer, according to Coherus BioSciences.

Pegfilgrastim-cbqv is a prefilled autoinjector designed to be administered to patients the day after chemotherapy as a single dose with a triggered push-on-skin activation. The agent is used to decrease the incidence of infection from febrile neutropenia associated with patients with non-myeloid malignancies who are receiving anti-cancer myelosuppressive therapy.

The approval of this autoinjector is supported by a comprehensive analytical data package and pharmacokinetic, pharmacodynamic, and immunogenicity study. With this approval, pegfilgrastim can be offered in 2 on-demand options, including as a prefilled syringe and an autoinjector. This will potentially allow for more flexibility when treating patients with cancer.

The most common adverse events which occurred in 5% or more of the patients in the experimental arm vs placebo were bone pain and extremity pain.

“The introduction of the autoinjector option for [pegfilgrastim-cbqv], with the ability to be administered at home or in the doctor’s office, will provide increased choice and control for patients and physicians, ultimately making treatment more accessible to patients,” Lee Schwartzberg, MD, chief of medical oncology and hematology at the Renown Health William N. Pennington Cancer Institute, and professor of Clinical Medicine at the University of Nevada, said in a press release.

In May 2022, the FDA approved pegfilgrastim-pbbk (Fylnetra), a biosimilar product, to also reduce the frequency of febrile neutropenia in patients with non-myeloid malignancies who are receiving myelosuppressive chemotherapy. Other pegfilgrastim biosimilars that are approved by the FDA include pegfilgrastim-apgf (Nyvepria), pegfilgrastim-bmez (Ziextenzo), and pegfilgrastim-jmdb (Fulphila).

Now, pegfilgrastim-cbqv can be used to reduce febrile neutropenia in patients with cancer and help increase survival for those who were acutely exposed to myelosuppressive doses of radiation.

Pegfilgrastim-cbqv is not indicated for the mobilization of peripheral blood progenitor cells for patients receiving hematopoietic stem cell transplant.

“There are certain types of patients [with cancer], those who live far away, have an active lifestyle, or who are supporting the needs of a busy family, for whom this option eliminates the need to return to the clinic and enables them to choose the time and place for treatment without having to wear an on-body device,” said Schwartzberg.

FDA approves UDENYCA® autoinjector. News release. FDA. Coherus BioSciences. March 6, 2023. Accessed March 9, 2023. https://bit.ly/3FdfLhq
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