After the inspection, the facility is working to improve quality control practices, according to a Dec. 12 news release.
CAR-T drugs, or chimeric antigen receptor T cell therapies, target cancer cells. The federal agency is currently investigating a potential link between the risk of lymphoma and BCMA-directed and CD19-directed CAR-T cell therapies.
The three CARsgen drugs on a clinical hold are “CT041,” a candidate focusing on the protein Claudin18.2 that targets gastric and gastroesophageal junction cancer and pancreatic cancer; “CT053,” a BCMA candidate for treating refractory and/or relapsed multiple myeloma; and “CT071,” which targets GPRC5D for the treatment of relapsed/refractory multiple myeloma or relapsed/refractory primary plasma cell leukemia.
At the Becker's 11th Annual IT + Revenue Cycle Conference: The Future of AI & Digital Health, taking place September 14–17 in Chicago, healthcare executives and digital leaders from across the country will come together to explore how AI, interoperability, cybersecurity, and revenue cycle innovation are transforming care delivery, strengthening financial performance, and driving the next era of digital health. Apply for complimentary registration now.
