BRIEF—ICER to postpone LentiGlobin assessment

US health technology assessor The Institute for Clinical and Economic Review (ICER) announced yesterday that it plans to postpone its ongoing assessment of bluebird bio’s LentiGlobin for the treatment of beta thalassemia.

Once a clearer timeframe for the therapy’s Food and Drug Administration review is known, it will reinitiate this assessment and announce an updated timeframe, which will include a new date for our public meeting.

On December 5, 2019, ICER  launched its 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.

The ICER anticipates that this additional time will enable bluebird to provide clinical trial data on a larger population of patients.