Immix Biopharma ‘applauds’ FDA labeling change notification for CAR-T products

Immix Biopharma announced a statement on January 2024, FDA labeling change notifications for approved CAR-T products: “We applaud FDA’s vigilance. Relapsed/refractory AL Amyloidosis remains an unmet medical need with limited treatment options. We believe that Immix Biopharma’s CAR-T candidates, with demonstrated ‘Single-Day CRS’ and a marked lack of neurotoxicity in our ongoing Phase 1b/2 clinical trial, will continue to exhibit a favorable tolerability profile moving forward. In our interim clinical data to date, we have not observed any secondary T-cell malignancies,” said Ilya Rachman, MD, PhD, Immix Biopharma Chief Executive Officer. Gabriel Morris, Chief Financial Officer of Immix Biopharma, added, “We believe NXC-201 will be uniquely suited to treat AL Amyloidosis and other autoimmune indications, given our interim clinical data in 73 patients to-date.”