FDA Grants RMAT Designation for P-BCMA-ALLO1 in Cancer Treatment

Monday, 16 September 2024, 08:30

Cancer treatment receives a significant boost as the FDA grants P-BCMA-ALLO1 RMAT designation for relapsed/refractory multiple myeloma. This investigational therapy shows promising safety and efficacy. The P-BCMA-ALLO1 agent, a cutting-edge CAR T-cell therapy, is advancing through clinical development.
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FDA Grants RMAT Designation for P-BCMA-ALLO1 in Cancer Treatment

Cancer Treatment Advances with RMAT Designation

The FDA has granted regenerative medicine advanced therapy (RMAT) designation to P-BCMA-ALLO1 for the potential treatment of relapsed/refractory (R/R) multiple myeloma.

P-BCMA-ALLO1 is an investigational stem cell memory T-cell (TSCM)-based allogeneic chimeric antigen receptor (CAR) T-cell therapy.

The agent is currently in phase 1/1b clinical development (NCT04960579).

Promising Early Results

Early results from an ongoing, phase 1 study of P-BCMA-ALLO1 highlighted the agent’s potential in offering promising efficacy and safety, as well as quick off-the-shelf patient access. In the study, P-BCMA-ALLO1 was well tolerated and displayed a favorable safety profile with no graft-vs-host disease (GVHD) seen in any patients treated at any dose. Additionally, low rates of grade 1/2 cytokine release syndrome and neurotoxicity were observed among all evaluable patients.

Future Presentations and Expectations

New findings from the phase 1 study of P-BCMA-ALLO1 will be presented at the 21st International Myeloma Society Annual Meeting, with additional results anticipated in the second half of 2024.


This article was prepared using information from open sources in accordance with the principles of Ethical Policy. The editorial team is not responsible for absolute accuracy, as it relies on data from the sources referenced.


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