Oxford BioMedica plc: Oxford BioMedica notes FDA Advisory Committee to review CTL019
June 07 2017 - 12:41PM
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).
Novartis announced in March 2017 that the FDA accepted CTL019
for review and granted priority review status.
Oxford 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.
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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