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OXB notes FDA Advisory Committee to review CTL019
OXB notes FDA Advisory Committee to review CTL019.
About this update from Oxford Biomedica Plc
[{"type":"text","content":"\n \nRNS Number : 3495H Oxford Biomedica PLC 07 June 2017 \n\n \n \n \n \n \n \nOxford BioMedica notes FDA Advisory Committee to review CTL019\n \nLondon, UK - 7 June 2017: Oxford BioMedica plc (\"Oxford BioMedica\" or \"the Group\") (LSE:OXB), a leading gene and cell therapy group, notes that the US Food and Drug Administration (FDA) has scheduled an Oncologic Drugs Advisory Committee meeting on 12 July 2017 to review the CTL019 (tisagenlecleucel-T) Biologics License Application (BLA) filing in relapsed and refractory (r/r) paediatric and young adult patients with B-cell acute lymphoblastic leukaemia (ALL).\nNovartis announced in March 2017 that the FDA accepted CTL019 for review and granted priority review status.\nOxford BioMedica is the sole manufacturer of the lentiviral vector expressing CTL019 for Novartis. As announced in October 2014, Oxford BioMedica will also receive undisclosed royalties on potential future sales of Novartis CAR-T products.\n- Ends -\n \n \n\n\n\n\nFor further information, please contact:\n\n\n \n\n\n\n\n \nOxford BioMedica plc:\nJohn Dawson, Chief Executive Officer\nTim Watts, Chief Financial Officer\n \n\n\n \nTel: +44 (0)1865 783 000\n\n\n\n\n \nConsilium Strategic Communications\nMary-Jane Elliott/Matthew Neal/Chris Welsh/Laura Thornton\n \n\n\n \n \nTel: +44 (0)20 3709 5700\n\n\n\n\n \nNotes for editors\n \n \nAbout Oxford BioMedica\n \nOxford BioMedica (LSE:OXB) is a leading gene and cell therapy group focused on developing life changing treatments for serious diseases. Oxford BioMedica and its subsidiaries (the \"Group\") have built a sector leading lentiviral vector delivery platform (LentiVector®), which the Group leverages to develop in vivo and ex vivo products both in-house and with partners. The Group has created a valuable proprietary portfolio of gene and cell therapy product candidates in the areas of oncology, ophthalmology and CNS disorders. The Group has also entered into a number of partnerships, including with Novartis, Sanofi, GSK, Orchard Therapeutics and Immune Design, through which it has long-term economic interests in other potential gene and cell therapy products. Oxford BioMedica is based across several locations in Oxfordshire, UK and employs more th...