Noted This Week

November 1–7

President Donald Trump nominated Stephen Hahn, MD, of The University of Texas MD Anderson Cancer Center in Houston, to be the next FDA commissioner. Acting FDA commissioner Norman “Ned” Sharpless, MD, will immediately return to his previous position as director of the NCI, and Brett Giroir, MD, the assistant secretary for health at the Department of Health and Human Services, will lead the FDA until Hahn is confirmed by the Senate.

Three patients with blood cancers were safely treated with CRISPR gene-editing technology. Researchers removed immune cells from the patients’ blood, genetically altered the cells to recognize and fight cancer, and reinfused them. After 2 to 3 months, one patient’s cancer continued to worsen, another patient experienced stable disease, and results are not yet available for the third patient.

MD Anderson and Takeda entered into a collaboration to develop chimeric antigen receptor natural killer (CAR NK)–cell therapies enhanced with IL15. Takeda will gain access to MD Anderson’s CAR NK platform and the exclusive right to develop and commercialize up to four products, including therapies that target CD19 and B-cell maturation antigen.

Daiichi Sankyo filed a lawsuit against Seattle Genetics over linker technology used in antibody–drug conjugates (ADC). In 2008 Seattle Genetics granted Daiichi a license to use its ADC technology, an agreement that ended in 2015. Now, Seattle Genetics is laying claim to the ADC technology used in Daiichi’s HER2-targeting agent DS-8201, which it began developing during the term of the agreement— and has continued developing since.

The FDA announced that the Office of Hematology and Oncology Products is being reorganized and renamed as the Office of Oncologic Diseases. The new office, which still falls within the Center for Drug Evaluation and Research, will increase from three to six divisions, each responsible for reviewing products for a different category of cancers. A safety team has also been added to assess and communicate safety information during the review process.

The agency also approved pegfilgrastim-bmez (Ziextenzo; Novartis), a biosimilar of pegfilgrastim (Neulasta; Amgen), based on evidence that it has a similar safety and efficacy profile as the reference drug. Pegfilgrastim-bmez, which is the third approved biosimilar of pegfilgrastim, decreases the risk of infection in patients with nonmyeloid cancer who are receiving chemotherapy and have febrile neutropenia.

Halozyme’s experimental HA-degrading drug PEGPH20 plus chemotherapy failed to extend overall survival in patients with pancreatic cancer compared with chemotherapy alone. Consequently, the company will discontinue its development and cut 160 jobs—55% of its workforce.

An article in JAMA reported that 27.5% of high schoolers and 10.5% of middle schoolers classified themselves as current users of electronic cigarettes (e-cigarettes) in 2019. The analysis, based on the 2019 National Youth Tobacco Survey, estimated that 4.1 million high school students and 1.2 million middle school students used the devices. A separate study in JAMA found that mint and mango were the most popular e-cigarette flavors among youth, and tobacco-related flavors were the least popular. In response, Juul Labs announced that it will sell only menthol and tobacco flavors.


Research Watch