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Kymriah receives positive CHMP opinion
Kymriah receives positive CHMP opinion.
About this update from Oxford Biomedica Plc
[{"type":"text","content":"\n \nRNS Number : 1022T Oxford Biomedica PLC 29 June 2018 \n\n \n \n \n \n \n \nKymriah (tisagenlecleucel, formerly CTL019) receives positive CHMP opinion for the treatment of two aggressive blood cancers, marking important milestone for patients in Europe \n \nLondon, UK - 29 June 2018: Oxford BioMedica plc (\"Oxford BioMedica\" or \"the Group\") (LSE:OXB), a leading gene and cell therapy group, today notes that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending approval of Novartis' Kymriah® (tisagenlecleucel, formerly CTL019) - a novel one-time treatment that uses a patient's own T cells to fight cancer. The positive opinion includes two B-cell malignancies: B-cell acute lymphoblastic leukaemia (ALL) that is refractory, in relapse post-transplant or in second or later relapse in patients up to 25 years of age; and diffuse large B-cell lymphoma (DLBCL) that is relapsed or refractory (r/r) after two or more lines of systemic therapy in adults. \n \nIf approved by the European Commission, Kymriah will be the first CAR-T cell therapy available in the European Union (EU) for both DLBCL and B-cell ALL \n \nOxford BioMedica is the sole manufacturer of the lentiviral vector that encodes the CD19-directed chimeric antigen receptor in Kymriah. The Group signed an agreement with Novartis in July 2017 for the commercial and clinical supply of lentiviral vectors used to generate Kymriah and other undisclosed CAR-T products, for which Oxford BioMedica could potentially receive in excess of $100m from Novartis over the next three years. As announced in October 2014, Oxford BioMedica will also receive undisclosed royalties on potential future sales of Novartis CAR-T products.\n \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\nStuart Paynter, Chief Financial Officer \n\n\n \nTel: +44 (0)1865 783 000\n\n\n\n\n \nConsilium Strategic Communications\nMary-Jane Elliott/Matthew Neal/\nOliver Manser/Laura Thornton\n\n\n \n \nTel: +44 (0)20 3709 5700\n\n\n\n\n \nNotes for editors\n \nAbout Oxford BioMedica\nOxford BioMedica (LSE:OXB) is a leading gen...