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# FDA Lifts Holds on Bluebird Bio Trials
- URL: https://www.fdaweb.com/fda-lifts-holds-on-bluebird-bio-trials/
- Published: 2021-06-07T12:00:00.000Z
- Updated: 2026-09-14T17:02:00.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5149480

FDA has lifted clinical holds against Bluebird Bio’s Phase 1/2 (HGB-206) and Phase 3 (HGB-210) studies of LentiGlobin gene therapy for sickle cell disease. The agency also lifted holds against the company’s Phase 3 Northstar-2 (HGB-207) and Northstar-3 (HGB-212) studies of betibeglogene autotemcel gene therapy in patients with transfusion-dependent β-thalassemia (TDT).

On 3/10, Bluebird Bio reported that it was unlikely the suspected serious adverse reaction of acute myeloid leukemia reported in the HGB-206 study was related to the BB305 lentiviral vector. “No cases of hematologic malignancy have been reported in any patient who has received treatment with beti-cel,” the company says. Additionally, on 4/20 Bluebird Bio announced a revised diagnosis for the previously reported case of myelodysplastic syndrome (MDS) in its Phase 1/2 study of LentiGlobin. “Upon further assessment, the treating investigator concluded this is not a case of MDS and revised the diagnosis to transfusion-dependent anemia,” it says.