ICER planned to assess the comparative clinical effectiveness and value of LentiGlobin (Bluebird Bio) for the treatment of beta thalassemia. LentiGlobin is an investigational gene therapy currently marketed in Europe under the brand name Zynteglo®.

On December 5, 2019, ICER launched our assessment of LentiGlobin, originally intending to conclude the review in August 2020. However, on February 18, 2020, bluebird announced that the company is engaged in discussions with the FDA regarding the requirements and timing of certain information to be provided in the rolling BLA submission; subject to these discussions, bluebird now is planning to complete its submission in the second half of 2020.

We anticipate that this additional time will enable bluebird to provide clinical trial data on a larger population of patients.

Date of Review: July 2020 – NOW POSTPONED

For questions, contact info@icer.org.

Intervention of Interest

  • LentiGlobin (Zynteglo®, Bluebird Bio)