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# FDA Extends Review on 2 bluebird Gene Therapies
- URL: https://www.fdaweb.com/fda-extends-review-on-2-bluebird-gene-therapies/
- Published: 2022-01-18T12:00:00.000Z
- Updated: 2026-09-14T17:28:53.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150949

FDA has extended by three months the user fee review action dates on two bluebird bio BLAs for its lentiviral vector gene therapies – betibeglogene autotemcel (beti-cel) for β-thalassemia and elivaldogene autotemcel (eli-cel) for cerebral adrenoleukodystrophy. The new review action target dates for beti-cel and eli-cel are 8/19 and 9/16, respectively. If approved, the company says beti-cel and eli-cel would be the first lentiviral vector gene therapies for patients with severe genetic diseases in the U.S.

The company says the review extensions are intended to provide FDA additional time to review clinical information previously submitted by the company in response to agency information requests. The submissions were deemed major amendments, it says, adding that they did not pertain to any new safety events for either beti-cel or eli-cel.

Additionally, bluebird says that a partial clinical hold is ongoing for lovotibeglogene autotemcel (lovo-cel) gene therapy clinical program for patients under the age of 18 with sickle cell disease. It says it has received written questions from FDA, and is continuing to evaluate whether the hold may delay a planned first quarter 2023 BLA submission.