FDA AdCom Recommends CTL019 for Approval

Released : 13.07.2017 07:00

RNS Number : 9230K
Oxford Biomedica PLC
13 July 2017
 

 

 

 

 

 

 

FDA Advisory Committee Unanimously Recommends CTL019 (tisagenlecleucel) for Approval

 

London, UK - 13 July 2017: Oxford BioMedica plc ("Oxford BioMedica" or "the Group") (LSE:OXB), a leading gene and cell therapy group, today notes that the US Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee voted unanimously 10 to 0 in favour of approval of Novartis investigational therapy CTL019 (tisagenlecleucel) for the treatment of relapsed and refractory (r/r) paediatric and young adult patients with B-cell acute lymphoblastic leukaemia (ALL).

Novartis announced in March that the FDA accepted its BLA filing and granted priority review for CTL019 in paediatric and young adult patients with B-cell ALL. The BLA review is ongoing and is under FDA priority review.

Oxford BioMedica is the sole manufacturer of the lentiviral vector that encodes CTL019. As announced in October 2014, Oxford BioMedica will also receive undisclosed royalties on potential future sales of Novartis CAR-T products. Oxford BioMedica recently signed an agreement with Novartis for the commercial and clinical supply of lentiviral vectors used to generate CTL019 and other undisclosed CAR-T products, for which Oxford BioMedica could potentially receive in excess of $100m from Novartis over the next three years.

John Dawson, Chief Executive Officer of Oxford BioMedica, commented: "The positive vote by 10 to 0 provides further support for CTL019, a novel immunocellular therapy, and we are proud to be a part of this important development. We continue to work closely with Novartis in delivering the lentiviral vector that encodes CTL019, a product the company described earlier this year as having "blockbuster" potential."

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For further information, please contact:

 

 

Oxford BioMedica plc:

John Dawson, Chief Executive Officer

Tim Watts, Chief Financial Officer

 

 

Tel: +44 (0)1865 783 000

 

Consilium Strategic Communications

Mary-Jane Elliott/Matthew Neal/Chris Welsh/Laura Thornton

 

 

 

Tel: +44 (0)20 3709 5700

 

Notes for editors

 

 

About Oxford BioMedica

 

Oxford 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 than 250 people. Further information is available at www.oxfordbiomedica.co.uk.

 

About FDA Advisory Committee meetings

 

FDA Advisory Committees consist of a panel of independent, external experts. The FDA convenes Advisory Committees to provide advice on scientific, technical and policy matters related to human and veterinary drugs, vaccines and other biological products, medical devices, and food. The FDA is not obligated to follow the advice of the committee.


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