Noted

Bristol Myers Squibb (BMS) announced it will acquire Turning Point Therapeutics for $4.1 billion. Turning Point's lead asset is repotrectinib, a next-generation tyrosine kinase inhibitor that targets ROS1 and other NTRK oncogenic drivers of non–small cell lung cancer. BMS expects repotrectinib to receive FDA approval in 2023.

JUUL Labs must stop selling and distributing all its electronic cigarette devices and pods, which are filled with nicotine-containing liquid that is vaporized and inhaled by users, and items 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.” Subsequently, a federal appeals court temporarily blocked the FDA action.

After reviewing 5-year survival results from the DUO trial, the FDA warned of a possible increase in the risk of death with duvelisib (Copiktra; Secura Bio), a PI3K inhibitor, compared with ofatumu­mab (Arzerra; Genmab/Novartis), an anti-CD20 monoclonal antibody. Patients in the trial who received duvelisib also had a higher risk of serious side effects, such as infections, diarrhea, and lung and intestinal inflammation. Duvelisib is used to treat adults with certain leukemias and lymphomas.

For some patients with HER2-negative, hormone receptor–positive metastatic breast cancer who have already received several therapies, taking Gilead's antibody–drug conjugate sacituzumab govitecan (Trodelvy) improved progression-free survival by 34% compared with physician's choice of chemotherapy—5.5 months versus 4 months. That's according to a study presented at the 2022 American Society of Clinical Oncology Annual Meeting in June.

BMS's Juno Therapeutics announced that the FDA approved lisocabtagene maraleucel (liso-cel; Breyanzi) for adults with large B-cell lymphoma who don't respond to, or relapse within 12 months of, first-line chemotherapy and are not eligible for hematopoietic stem cell transplantation. Liso-cel was approved with a Risk Evaluation and Mitigation Strategy because of the risk of fatal or life-threatening cytokine release syndrome and neurologic toxicities.

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