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Noted This Week

June 17–23

JUUL Labs must stop selling and distributing all its electronic cigarette (e-cigarette) devices and pods, which are filled with nicotine-containing liquid that is vaporized and inhaled by users, and products currently on the market must be removed from store shelves, the FDA ordered. The agency said that the company’s applications to sell the products "lacked sufficient evidence…that marketing of the products would be appropriate for the protection of the public health." The FDA has said that e-cigarette use has dramatic increased among youth, but the company, which plans to appeal the decision, has advertised its e-cigarettes as a tool to help current smokers quit using traditional combustible cigarettes.

Novartis announced that the FDA granted accelerated approval to the combination of dabrafenib (Tafinlar) and trametinib (Mekinist) to treat BRAFV600E-mutant tumors—namely in patients age 6 and older with inoperable or metastatic solid tumors whose disease has progressed following other treatment and who have no satisfactory alternative treatment options. The combination is not indicated for patients with colorectal cancer; dabrafenib is not indicated for patients with wild-type BRAF solid tumors. The decision was based on findings from multiple cohort trials that involved 131 adults and 36 children with 24 types of cancer; the overall response rates (ORR) were 41% and 25%, respectively.

Novartis also reported that the European Commission approved capmatinib (Tabrecta) to treat adults with advanced non–small cell lung cancer (NSCLC) harboring alterations leading to MET exon 14 skipping mutations who require systemic therapy following treatment with immunotherapy and/or platinum-based chemotherapy. The approval was based on results of the phase II GEOMETRY mono-1 trial, which demonstrated an ORR of 51.6% in 31 patients who had already received at least two therapies; among 100 patients who had already received at least one systemic therapy, the ORR was 44%. The most common treatment-related adverse events were peripheral edema, nausea, vomiting, and increased blood creatinine.

A report from researchers at the American Cancer Society in collaboration with the NCI found more than 18 million Americans who have had cancer were alive in the United States as of January 1, with 12 million (67%) age 65 or older and more than half (53%) diagnosed within the last decade (CA Cancer J Clin 2022 Jun 23 [Epub ahead of print]). They noted that the increased survival was mainly due to a growing and aging population as well as advances in early detection and treatment. However, the researchers said that their data indicate substantial racial disparities in treatment—for example, Black patients are much less likely to have surgery for NSCLC than whites: 49% versus 55%, respectively, for stage I and II disease and 16% versus 22% for stage III.

Japanese researchers reported that mRNA vaccines against SARS-CoV-2 are safe and effective in patients being treated for lung cancer with immune checkpoint inhibitors (ICI), such as anti–PD-1, anti–PD-L1, and anti-CTLA4 antibodies (J Thorac Oncol 2022 Jun 22 [Epub ahead of print]). They enrolled 126 patients a in trial to learn whether the incidence of immune-related adverse events (irAE) in these patients was less than 35%, a standard set by earlier studies. They found that 26 patients (20.6%) and seven patients (5.6%) developed new irAEs of any grade pre-and post-vaccination, respectively, but their antibody levels were significantly lower compared with control subjects who did not receive anticancer or ICI therapies.

Susan G. Komen for the Cure awarded $21.7 million to fund 48 research projects at 26 academic medical centers in the United States. Of that amount, 79% supports research on the most aggressive breast cancers, metastasis, and recurrence; 33% supports clinical trials; and 20% supports research on eliminating disparities in breast cancer diagnosis and treatment. The organization says it now supports more than 152 active research projects thanks to more than $115 million in funding.

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