Report: Health care disparities exist across all US states | Atopic dermatitis drug could raise risk of cutaneous T cell lymphoma | Close monitoring could prevent venetoclax resistance in patients with MDS
April 19, 2024
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News for the transfusion medicine and biotherapies community
The FDA announced it will require changes to the boxed warnings of chimeric antigen receptor T-cell therapies for cancers to highlight the risk of secondary blood cancer among users. The agency noted that patients and clinical trial participants receiving CAR T-cell therapies should receive lifelong monitoring for secondary cancers, and the drug manufacturer should be informed if new malignancies happen.
A Commonwealth Fund report indicates that major ethnic and racial disparities in health care and health outcomes persist across and within US states, particularly among Blacks, American Indian and Alaska Natives, caused by disproportionate access to high-quality care. Policymakers should work to ensure access to affordable and equitable health care coverage, improve primary care and service delivery, invest in social services and reduce administrative burdens to promote health equity and reduce health disparities, report authors wrote.
A study in the Journal of the American Academy of Dermatology showed that patients with atopic dermatitis treated with dupilumab were at greater risk of developing cutaneous T cell lymphoma than patients who did not receive dupilumab. The increased risk for cutaneous T cell lymphoma persisted even after excluding patients who previously received disease-modifying antirheumatic drugs, the study authors wrote.
Researchers found that patients with myelodysplastic syndromes who receive venetoclax-based therapies may need close molecular monitoring to avoid hematopoietic stem and progenitor cell hierarchical changes that may lead to venetoclax resistance. The study was published in the journal Nature Communications.
The World Health Organization issued a new report that updates terminology for pathogens that transmit through the air, including those that cause respiratory infections such as COVID-19, measles, tuberculosis, influenza, measles and severe acute respiratory syndrome. According to the report, "through the air transmission" describes infectious diseases that spread through airborne transmission or inhalation, in which infectious respiratory particles are expelled into the air and inhaled by another person, and through direct deposition, in which particles are expelled into the air and land on another person's exposed mouth, nose or eyes.
Research shows that a Medicare initiative called Chronic Care Management decreased patients' emergency department and inpatient visits and reduced total health spending, but only a small proportion of eligible enrollees have participated. A number of businesses have been started to help physicians participate, but physician uptake has still been low for reasons including lack of capacity to monitor patients outside office visits, high documentation requirements, and reluctance to require people to participate when they do not have a supplemental policy.
Takeda and Kumquat Biosciences will partner to develop an oral small molecule inhibitor immune-oncology candidate after signing a deal worth over $1.2 billion. The deal grants Takeda an exclusive global license to develop and commercialize the chosen asset as either a monotherapy, combination therapy or both.
The FDA has released the Chemicals List for Analytical Performance, a chemical dataset that is intended to aid medical device sponsors in the biocompatibility testing and review processes. "A central tenet of the [Center for Devices and Radiological Health] biocompatibility evaluation is for sponsors to have the option, for some biocompatibility endpoints, to undertake extraction studies to identify and quantify chemicals released from a device and then to perform a toxicological risk assessment (TRA) to determine if the chemicals pose safety issues in the use of the device," said CDRH Director Jeff Shuren.
The April issue of AABB News shines a spotlight on the contributions of military transfusion medicine. The first feature discusses the benefits of walking blood banks while the second explores the evolution of whole blood transfusions. Non-members may access a complimentary preview.