FDA Approves Pegfilgrastim Biosimilar to Mitigate Febrile Neutropenia From Chemo

The FDA has approved pegfilgrastim-cbqv (Udencya), a pegfilgrastim biosimilar, with a prefilled autoinjector presentation with the intention of decreasing chemotherapy-associated febrile neutropenia in patients with cancer, according to a press release from Coherus BioSciences.

The autoinjector was designed to administer a single dose with a triggered push-on-skin activation that immediately administers a dose of pegfilgrastim-cbqv. The autoinjector was supported by a comprehensive analytical data package and pharmacokinetic, pharmacodynamic, and immunogenicity study. This approval will allow pegfilgrastim to be offered in 2 on-demand options; a prefilled syringe and an autoinjector, potentially allowing for more flexibility when treating patients.

Pegfilgrastim can be administered the day after chemotherapy treatment to help reduce febrile neutropenia. The biosimilar is indicated for use in patients with non-myeloid malignancies who are receiving myelosuppressive anti-cancer drugs to help reduce febrile neutropenia. Additionally, it can be used to help increase survival for those who were acutely exposed to myelosuppressive doses of radiation.

It is not indicated for use in the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplant.

“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.

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

“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.

In June 2022, the FDA granted a biologics license application to pegfilgrastim-pbbk (Flynetra) as a treatment for neutropenia in patients undergoing chemotherapy.

Reference

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