Oncology Advances: FDA Approves P-BCMA-ALLO1 RMAT Designation for Cancer Treatment
FDA Approval Highlights
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.
Promising Clinical Development
P-BCMA-ALLO1 is an investigational stem cell memory T-cell (TSCM)-based allogeneic chimeric antigen receptor (CAR) T-cell therapy currently under phase 1/1b clinical development (NCT04960579). Early results from this ongoing study indicate its potential in offering efficacy and safety, along with quick off-the-shelf access for patients.
- Well Tolerated: No graft-versus-host disease (GVHD) seen in treated patients
- Favorable Safety Profile: Low rates of grade 1/2 cytokine release syndrome
- Ongoing Research: Results to be presented at the 21st International Myeloma Society Annual Meeting.
Additional results are expected to be released in the second half of 2024.
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