The U.S. Food and Drug Administration (FDA) has granted P-BCMA-101, Poseida Therapeutics’ CAR T-cell therapy and lead product candidate, the Regenerative Medicine Advanced Therapy (RMAT) designation for the treatment of relapsed or refractory multiple myeloma.
Preliminary results from a Phase 1 trial (NCT03288493) suggest the candidate is safe and may have superior effectiveness compared with other CAR T-cell therapies.
The RMAT designation is granted to regenerative therapies intended to treat, modify, reverse, or cure a serious condition, and for which preliminary clinical data evidences the therapy’s potential to address unmet medical needs for a condition.
The statute grants all the benefits of a Fast Track and Breakthrough Therapy designation, including early interactions with sponsors and the FDA, which may be used to discuss intermediate or surrogate clinical trial endpoints and support accelerated approval of the therapy.
P-BCMA-101 is designed to target the B cell maturation antigen (BCMA), a protein highly expressed at the surface of virtually all multiple myeloma cells.
The therapy is based on the patient’s own T-cells, which are taken from the blood and genetically engineered to recognize BCMA and destroy cells producing this factor.
Read more at: https://myelomaresearchnews.com/2018/11/19/fda-grants-poseidas-p-bcma-101-regenerative-medicine-advanced-therapy-multiple-myeloma/?amp&fbclid=IwAR3HgyO7mL20lkmVx4ZDsXaMN_HkhidXTG73edpybzB_QuVNNVqFSUFnEdg