Noted

A scant 1.8% of the $26.6 billion collected by state governments from tobacco taxes and settlement funds in this fiscal year will be spent on smoking cessation programs, according to a report from several organizations (see www.tobaccofreekids.org). The group noted that although it would take less than 13% of total state tobacco revenues to fund such programs at levels recommended by the Centers for Disease Control and Prevention, only North Dakota and Alaska are doing so.

The FDA released a guidance document for industry on clinical pharmacology data to support the demonstration of biosimilarity to a reference product (see www.fda.gov). By law, companies seeking FDA approval of a biologic product that is highly similar to an existing one must show that there are no clinically meaningful differences between the products.

The FDA placed holds on early-stage trials of vadastuximab talirine (Seattle Genetics), an investigational antibody–drug conjugate targeting CD33, in patients with acute myeloid leukemia who had an allogeneic stem cell transplant, to evaluate hepatotoxicity risk. The holds were initiated after six patients were identified with hepatotoxicity and four patients died.

Unlike adults, children with cancer treated with radiotherapy or chemotherapy are at high risk of developing cardiac and neurologic problems later in life. A recent study may explain the disparity: Researchers found that mitochondria of many adult tissues are refractory to proapoptotic signaling, leading to cellular resistance to radiation and chemotherapy, whereas mitochondria from tissues in young mice and children are “primed for apoptosis,” predisposing them to “cell death in response to genotoxic damage” (Cancer Cell 2017;31:142–56).

Vice President Joe Biden told The Washington Post that he will create a nonprofit organization to continue focusing on cancer issues after he leaves office. He indicated his desire to “get Congress and advocacy groups to make sure [cancer] treatments are accessible for everyone … and that we have a more rational way of paying for them while promoting innovation.”

For more news on cancer research, visit Cancer Discovery online at http://cancerdiscovery.aacrjournals.org/content/early/by/section.