In This Article
- FDA Approves Ziextenzo, Third Biosimilar to Pegfilgrastim for Febrile Neutropenia
- Trump Will Nominate Dr Hahn as Next FDA Commissioner
- Researchers Report High Rates of E-Cigarette Use Among Children and Teens
FDA Approves Ziextenzo, Third Biosimilar to Pegfilgrastim for Febrile Neutropenia
On November 5, 2019, the FDA approved pegfilgrastim-bmez (Ziextenzo; Sandoz), a granulocyte colony-stimulating factor, as a biosimilar to the reference drug Neulasta (pegfilgrastim; Amgen). This is the third biosimilar to Neulasta to receive FDA approval, after Fulphila (pegfilgrastim-jmdb; Mylan) in June 2018 and Udenyca (pegfilgrastim-cbqv; Coherus BioSciences) in November 2018.
Pegfilgrastim-bmez is approved for the same indications as its reference drug—to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies who receive myelosuppressive drugs associated with a clinically significant incidence of febrile neutropenia. Pegfilgrastim-bmez is not approved for the mobilization of peripheral blood progenitor cells for hematopoietic stem-cell transplantation.
The FDA approval of pegfilgrastim-bmez was based on data from analytical, preclinical, and clinical studies showing that it is highly similar to its reference drug, and that there are no clinically meaningful differences between the biosimilar and its reference drug.
Febrile neutropenia is a serious complication of chemotherapy that can lead to treatment delays and chemotherapy dose reductions, which compromise the efficacy of treatment. Granulocyte colony-stimulating factors are frequently used to increase white blood cell production and to reduce the incidence of infections in patients with specific types of cancer who are receiving chemotherapy.
In a company press release, Carol Lynch, President of Sandoz, the drug’s manufacturer, said, “When a cancer patient with febrile neutropenia gets an infection, it can have serious consequences such as delays or dose reductions of chemotherapy. The approval of Ziextenzo expands our oncology portfolio, providing physicians with a long-acting supportive oncology biosimilar option.”
In the United States, more than 60,000 patients with cancer are hospitalized annually with neutropenia, and more than 4000 deaths will occur because of this life-threatening complication.
Trump Will Nominate Dr Hahn as Next FDA Commissioner
On November 1, 2019, the White House announced President Donald Trump’s intention to nominate Stephen M. Hahn, MD, FASTRO, Chief Medical Executive, The University of Texas M.D. Anderson Cancer Center, as the new Commissioner of the FDA. If confirmed, Dr Hahn will replace Norman “Ned” Sharpless, MD, who has been the Acting Commissioner of the FDA since Scott Gottlieb, MD, resigned from his position unexpectedly in April 2019. By law, Dr Sharpless could only serve as Acting Commissioner for 210 days, and will now return to his position as Director of the National Cancer Institute.
The Senate will vote on whether to confirm Dr Hahn to the post of FDA Commissioner. The confirmation hearing before the Senate Health, Education, Labor, and Pensions Committee is set for November 20, 2019. In the interim, Brett P. Giroir, MD, Assistant Secretary for Health, US Department of Health and Human Services, will temporarily lead the agency.
If Dr Hahn assumes the role of FDA Commissioner, he will be tasked with addressing several urgent public health issues, including the high price of prescription drugs, the problem of underage vaping and tobacco use, and the opioid epidemic.
Unlike his predecessors, including Dr Gottlieb, Robert M. Califf, MD, MACC, and Margaret Hamburg, MD, Dr Hahn does not have any experience serving in a high-level health policy role. However, his nomination has been supported by numerous medical associations, including the American Hospital Association (AHA), which stated:
“The AHA welcomes the nomination of Dr. Stephen Hahn, a renowned oncologist and physician leader, to be the next commissioner of the Food and Drug Administration. As the chief medical executive at The University of Texas MD Anderson Cancer Center, Dr. Hahn leads the medical practice at one of the world’s top hospitals devoted to cancer care, research, education and prevention. We believe that Dr. Hahn’s more than 20 years of experience on the front lines of delivering patient care, overseeing clinical research and operations, and quality and safety initiatives makes him a uniquely qualified nominee to lead the FDA.”
Researchers Report High Rates of E-Cigarette Use Among Children and TeensFindings from the 2019 National Youth Tobacco Survey, detailed in an article by Cullen and colleagues that was recently published in the Journal of the American Medical Association, show that among high school students, an estimated 27.5% admitted to currently using e-cigarettes, with 34.2% reporting frequent use (defined as 20 of the past 30 days). Among middle school students, 10.5% admitted to currently using e-cigarettes, with 18.0% reporting frequent use. Only 5.8% and 2.3% of high school and middle school students, respectively, reported current cigarette smoking. The study also found that a high percentage of high school and middle school students preferred flavored e-cigarettes, such as those that taste like fruit, menthol, mint, candy, or desserts (Cullen KA, et al. JAMA. 2019. Epub ahead of print).
The researchers asserted that the frequent use of e-cigarettes among children and teens was very troubling, given the fact that some products contain high concentrations of a modified, salt-based nicotine, which is more readily absorbed upon inhalation. This can lead to faster nicotine dependence and make it easier for adolescents to proceed to regular e-cigarette use or to transition to other tobacco-based combustible products, all of which can affect normal brain activity.
“Most e-cigarettes contain nicotine and nicotine exposure during adolescence can harm the developing brain, which continues to develop until about age 25 years. Nicotine exposure during adolescence can affect learning, memory, and attention and can increase risk for future addiction to other drugs,” the researchers noted.
The FDA continues to increase its efforts to deter the use of nicotine-based products among children and teens. These efforts include the launch of new television advertisements warning young people about the dangers of e-cigarette use. The agency is also providing middle schools and high schools with posters and other educational materials as part of “The Real Cost” Youth E-Cigarette Prevention Campaign, which uses hard-hitting advertising aimed at the approximately 10.7 million adolescents in the United States who have used e-cigarettes or are open to trying them.