BCB-276 Earns FDA Breakthrough Therapy Nod for Pediatric Diffuse Intrinsic Pontine Glioma

BCB-276 cell therapy for brain cancer DIPG gets new FDA status

BCB-276, an experimental cell therapy that Brainchild Bio is developing for diffuse intrinsic pontine glioma (DIPG), has been named a regenerative medicine advanced therapy by the U.S Food and Drug Administration (FDA). This designation, abbreviated RMAT, is given by the FDA to experimental therapies that have shown early clinical promise for addressing unmet needs in the treatment of serious conditions. Investigational therapies granted the des…

FDA Grants RMAT Designation to CAR T Therapy for Incurable Pediatric Glioma

The B7-H3 CAR T-cell therapy showed positive survival results for younger patients with diffuse intrinsic pontine glioma in a phase 1 trial.

FDA grants RMAT to BrainChild Bio's CAR T-cell therapy for DIPG

This marks a step forward in the development of treatments for this incurable paediatric brain tumour. BrainChild Bio noted that a CAR T-cell therapy overcomes the challenges posed The post FDA grants RMAT to BrainChild Bio’s CAR T-cell therapy for DIPG appeared first on Pharmaceutical Business review.

Investigational CAR T-Cell Therapy BCB-276 Receives FDA Breakthrough Designation for Pediatric Patients With DIPG

The agent targets B7-H3, a commonly overexpressed protein in diffuse intrinsic pontine glioma (DIPG).

Breakthrough Designation Granted to BCB-276 for Pediatric DIPG

Findings from the phase 1 BrainChild-03 trial support breakthrough designation for BCB-276 for pediatric diffuse intrinsic pontine glioma.

BCB-276 Earns FDA Breakthrough Therapy Nod for Pediatric Diffuse Intrinsic Pontine Glioma

The FDA granted breakthrough therapy designation to BCB-276 for pediatric diffuse intrinsic pontine glioma.