Strimvelis: risk of lymphoid T-cell leukaemia?
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Strimvelis: risk of lymphoid T-cell leukaemia? Orchard Therapeutics is advising that a patient treated with its gammaretroviral vector-based gene therapy, simoladagene autotemcel [Strimvelis], under a compassionate use program in 2016 has been diagnosed with lymphoid T-cell leukaemia. The gene therapy was approved by the European Medicines Agency (EMA) for the treatment of adenosine deaminase severe combined immunodeficiency (ADA-SCID). "Preliminary findings suggest this diagnosis may be attributable to an insertional event related to treatment with Strimvelis. The patient is undergoing treatment for the leukemia at a specialty center, and we are conducting a full investigation to determine potential causality," said Orchard Therapeutics. Leukaemia resulting from the insertion of gammaretroviral vectors into the genome is described in Strimvelis product information as a potential risk of gammaretroviral vector-based gene therapy. Orchard has notified the EMA and other European regulatory authorities of this adverse event. In total, 16 patients have been treated with Strimvelis since it was approved by the EMA in 2016. No further patients will be treated with this gene therapy until the investigation into this adverse event is complete. Orchard Therapeutics. Orchard Statement on Strimvelis, a Gammaretroviral Vector-Based Gene Therapy for ADA-SCID. Internet Document : 30 Oct 2020. Available from: 803515035 URL: https://ir.orchard-tx.com/news-releases/news-release-details/orchard-statement-strimvelisr-gammaretroviral-vector-based-gene
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Reactions 14 Nov 2020 No. 1830
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