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FDA Grants Regenerative Medicine Advanced Therapy Designation to CAR T-Cell Therapy

By: Sarah Jackson
Posted: Wednesday, November 28, 2018

The U.S. Food and Drug Administration (FDA) recently granted a Regenerative Medicine Advanced Therapy designation to P-BCMA-101, a chimeric antigen receptor (CAR) T-cell therapy currently in a phase I clinical trial (ClinicalTrials.gov identifier NCT03288493) for the treatment of patients with relapsed or refractory multiple myeloma. This designation includes all of the benefits of the Fast Track and Breakthrough Therapy designation programs, including early interactions with the FDA.

P-BCMA-101 is an autologous CAR T-cell therapy being developed to treat patients with relapsed or refractory multiple myeloma. It targets cells that express B-cell maturation antigen (BCMA), which is expressed in essentially all multiple myeloma cells. Preliminary results from the ongoing phase I clinical trial suggest that P-BCMA-101 is active with a favorable safety profile, including responses in a heavily pretreated population. Low to no levels of cytokine-release syndrome or neurotoxicity have been reported. The phase I study is funded in part by the California Institute for Regenerative Medicine.



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