ZYNTEGLO

STN: 125717
Proper Name: betibeglogene autotemcel
Tradename: ZYNTEGLO
Manufacturer: bluebird bio Inc.
Indication:

• For treatment of adult and pediatric patients with ß-thalassemia who require regular red blood cell (RBC) transfusions

Product Information

• 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.

Supporting Documents

• August 17, 2022 Approval Letter - ZYNTEGLO
• August 17, 2022 Summary Basis for Regulatory Action - ZYNTEGLO
• Approval History, Letters, Reviews and Related Documents - ZYNTEGLO

Related Information

• FDA Approves First Cell-Based Gene Therapy to Treat Adult and Pediatric Patients with Beta-thalassemia Who Require Regular Blood Transfusions