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.
Becker’s 3rd Annual Fall Chief Pharmacy Officer Summit is the top tier event that the people leading the future of pharmacy convene. This 3-day event is built specifically for Chief Pharmacy Officers and senior pharmacy leaders. The sessions examine the workforce, financial and clinical priorities shaping pharmacy today. Becker’s is where candid discussions flourish and new ideas thrive. Becker's 3rd Annual Fall Chief Pharmacy Officer Summit
