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Betibeglogene Autotemcel

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August 17, 2022
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FDA approves Zynteglo for patients with transfusion-dependent beta-thalassemia

The FDA approved betibeglogene autotemcel for treatment of patients with beta-thalassemia who require routine red blood cell transfusions.

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July 21, 2022
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ICER report: Evidence adequate of beti-cel benefit for patients with beta-thalassemia

Adequate evidence exists to show betibeglogene autotemcel confers a net health benefit vs. standard clinical management for patients with beta-thalassemia, according to a final evidence report by Institute for Clinical and Economic Review.

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December 12, 2021
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Gene therapy potentially curative for patients with transfusion-dependent beta-thalassemia

Patients with transfusion-dependent beta-thalassemia who received betibeglogene autotemcel achieved durable transfusion independence with near-normal hemoglobin levels, according to study results with up to 7 years of follow-up.

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November 22, 2021
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FDA grants priority review to betibeglogene autotemcel for beta-thalassemia

The FDA granted priority review to betibeglogene autotemcel, a gene therapy in development to treat patients with transfusion-dependent beta-thalassemia.

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September 22, 2021
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bluebird bio submits BLA for single-dose gene therapy to treat beta-thalassemia

The FDA received a completed rolling biologics license application for betibeglogene autotemcel, a gene therapy in development to treat patients with transfusion-dependent beta-thalassemia.

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June 11, 2021
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FDA lifts hold on trials of gene therapies for sickle cell disease, beta-thalassemia

The FDA lifted the clinical holds on four studies designed to evaluate two gene therapies for hematologic conditions.

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February 25, 2021
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Top in hem/onc: Sickle cell gene therapy, primary care in cancer centers

Last week, bluebird bio suspended clinical trials with its LentiGlobin product for sickle cell disease due to reported cases of hematologic malignancies among patients who received the treatment. It was the top story in hematology/oncology.

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February 18, 2021
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Gene therapy shows durable efficacy for transfusion-dependent beta-thalassemia

Long-term follow-up data showed betibeglogene autotemcel to be a safe and efficacious treatment for patients with transfusion-dependent beta-thalassemia, according to study results presented at TCT Meetings Digital Experience.

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February 17, 2021
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Manufacturer suspends clinical trials for gene therapy to treat sickle cell disease

Gene therapy developer bluebird bio suspended clinical trials using its LentiGlobin product for sickle cell disease due to reported cases of hematologic malignancies among patients who received the treatment.