Abstract
A collection of recently published news items.
Norman E. “Ned” Sharpless, MD, became acting commissioner of the FDA in April, replacing Scott Gottlieb, MD, who resigned. Sharpless had served as the NCI's director since October 2017. Deputy NCI Director Doug Lowy, MD, will become the NCI's acting director. Gottlieb was confirmed as head of the FDA in May 2017.
The FDA granted accelerated approval to atezolizumab (Tecentriq; Genentech) in combination with nab-paclitaxel (Abraxane; Celgene) for patients with inoperable advanced or metastatic triple-negative breast cancer whose tumors express PD-L1. In a phase III trial, the combination extended median overall survival by 2.6 months compared with a placebo plus nab-paclitaxel. A PD-L1 inhibitor, atezolizumab is the first immunotherapy approved for breast cancer.
Researchers developed an ALK-targeted antibody–drug conjugate for neuroblastoma (Science Transl Med 2019;11:eaau9732). The drug, CDX-0125-TEI, combines a monoclonal antibody that recognizes ALK-expressing cells with the alkylating chemotherapy agent thienoindole. In laboratory experiments, it eliminated neuroblastoma cells in mouse models and cell cultures without damaging healthy cells.
The FDA granted breakthrough designation to an artificial intelligence (AI) tool designed by Paige.AI, the first such technology to receive the designation for cancer diagnosis. Launched last year, the company is training its deep-learning AI tool on digitized cancer pathology slides—to date, the company has more than 1 million slides, with another 4 million to be added across cancer subtypes. Paige.AI plans to first market its AI technology for prostate cancer.
Medicaid coverage of lung cancer screening for high-risk individuals varies widely by state, according to an American Lung Association report (available at https://www.lung.org). The report notes that 31 states cover screening through Medicaid and 12 states do not; seven others do not have publicly available policies. In total, 26.3% of those on Medicaid are current smokers, a key risk factor for developing lung cancer.
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