Proper Name: betibeglogene autotemcel
Manufacturer: bluebird bio Inc.
- For treatment of adult and pediatric patients with ß-thalassemia who require regular red blood cell (RBC) transfusions
- Package Insert - ZYNTEGLO
- Demographic Subgroup Information – betibeglogene autotemcel [ZYNTEGLO]
Refer to Section 1.1 of the Clinical Review Memo for information about participation in the clinical trials and any analysis of demographic subgroup outcomes that is notable.
- August 17, 2022 Approval Letter - ZYNTEGLO
- August 17, 2022 Summary Basis for Regulatory Action - ZYNTEGLO
- Approval History, Letters, Reviews and Related Documents - ZYNTEGLO
- FDA Approves First Cell-Based Gene Therapy to Treat Adult and Pediatric Patients with Beta-thalassemia Who Require Regular Blood Transfusions