A collection of recently published news items.
During his State of the Union address, President Joe Biden emphasized his goal to cut cancer death rates by at least 50% over the next 25 years by reigniting the Cancer Moonshot program launched in 2016 under President Barack Obama. The Moonshot will largely focus on screening, prevention, and early detection initiatives.
The U.S. Congress gave the FDA's Center for Tobacco Products the authority to regulate synthetic nicotine. The FDA has had the authority to regulate nicotine derived from tobacco plants but whether the agency could regulate nicotine from other sources has been unclear. Thus, some companies have continued to sell flavored electronic cigarettes, which appeal to children and teenagers, that contain synthetic nicotine. The agency can now regulate nicotine no matter its source.
Seagen and Genmab announced that the antibody–drug conjugate tisotumab vedotin (Tivdak) demonstrated a manageable safety profile and promising preliminary antitumor activity in patients with squamous cell carcinoma of the head and neck, with an objective response rate of 16% (five of 31 patients). In the phase II innovaTV 207 trial, the median follow-up was 10 months, disease control rate was 58.1%, median progression-free survival was 4.2 months, and median overall survival (OS) was 9.4 months.
The FDA approved olaparib (Lynparza; Merck) for the adjuvant treatment of patients with germline BRCA-mutant, HER2-negative high-risk early breast cancer who have already received chemotherapy. The approval was based on findings from the OlympiA trial, in which the drug reduced the risk of invasive breast cancer recurrences, second cancers, or death by 42% versus placebo.
However, Merck said the combination of olaparib and the PD-1 inhibitor pembrolizumab (Keytruda) did not demonstrate an improvement in OS in patients with metastatic castration-resistant prostate cancer compared with the control arm, in which patients received either abiraterone or enzalutamide. As a result, the phase III KEYLYNK-010 trial assessing the combination will be discontinued.
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