The Food and Drug Administration has approved the biosimilar Ziextenzo (pegfilgrastim-bmez) to reduce the incidence of infection in patients with nonmyeloid cancer receiving suppressive anticancer drugs that are associated with febrile neutropenia.
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More than 60,000 cancer patients are hospitalized in the United States each year with evidence of neutropenia, resulting in more than 4,000 deaths, according to Ziextenzo maker Sandoz, a Novartis division.
The FDA approval was based on analytical, preclinical, and clinical research, including data from a three-way pharmacokinetics and pharmacodynamics study that compared pegfilgrastim-bmez with the reference drug pegfilgrastim (Neulasta) from the United States and the European Union. Pharmacokinetic and pharmacodynamic similarity were shown between pegfilgrastim-bmez with the reference drugs, and there were no clinically significant differences in safety or immunogenicity.
The most common adverse events associated with pegfilgrastim-bmez are bone pain and pain in the extremities, according to the label.