The FDA issues updated guidance on the emergency use authorization (EUA) process for COVID-19 screening tools; Eli Lilly releases patient-reported outcome results for Verzenio (abemaciclib) in breast cancer; COVID-19 vaccines possibly improve long-haul symptoms among patients.
The FDA’s Office of the Center Director has issued updated guidance for companies seeking emergency use authorization (EUA) for their COVID-19 screening tests for asymptomatic individuals in a move to streamline the process and expand test availability. The new guidance includes a supplemental template for developers of serial molecular and antigen testing on what information to submit to the FDA for a pre-EUA or an EUA, as well as a fact sheet for various institutions (eg, schools, workplaces, communities, etc) on choosing the most appropriate test.
Verzenio (abemaciclib) plus standard adjuvant endocrine therapy (ET) for hormone receptor–positive, human epidermal growth factor receptor 2–negative high-risk early breast cancer has been shown to not increase most adverse effects among patients, according to phase 3 data presented at this year’s St. Gallen International Breast Cancer Conference. Diarrhea, however, was more common in this cohort compared with those receiving just standard ET. The data add to previous positive findings from the phase 3 monarchE trial, which show an almost 30% reduction in the risk of breast cancer from adding the CDK 4/6 inhibitor to treatment with ET.
According to the National Institutes of Health (NIH), 10% to 30% of cases of COVID-19 produce long-lasting symptoms, and The Washington Post is reporting these symptoms are dissipating in some patients following vaccination with their first shot or a booster. But these findings have only led to more confusion, the NIH reports, including if this is only a placebo effect and that hidden coronavirus reservoirs are enabling such reactions. Meanwhile, experts continue to stress the importance of getting immunized, noting the benefits outweigh the risks, especially that the vaccines reduce chances of long-term COVID-19. The NIH is currently studying the prolonged effects of COVID-19 following $1.15 billion in funding from Congress.