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Authorization of EBVALLO\u2122 (tabelecleucel)","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Approved","country":"FRANCE","productType":"Cell and Gene therapy","productStatus":"Approved","date":"February 2023","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Approved"},{"orgOrder":0,"company":"Atara Biotherapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Atara Biotherapeutics Announces Plans to Submit Tab-cel\u00ae BLA in Q2 2024 Following FDA Agreement on Comparability","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"Approved","date":"September 2023","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase III"}]
Find Clinical Drug Pipeline Developments & Deals for Tabelecleucel
Atara has entered into a partnership with Pierre Fabre for the U.S. and remaining global commercial markets for Tab-Cel (Tabelecleucel), which is indicated for the treatment of EBV-positive post-transplant lymphoproliferative disease.
Under the terms of the agreement, Pierre Fabre gains U.S. and remaining global commercial markets for tab-cel (tabelecleucel), an allogeneic Epstein-Barr virus (EBV)-specific T-cell immunotherapy.
tab-cel (tabelecleucel) is an allogeneic, EBV-specific T-cell immunotherapy which targets and eliminates EBV-infected cells in an HLA-restricted manner.
Ebvallo™ (tabelecleucel) is an allogeneic, EBV-specific T-cell immunotherapy which targets and eliminates EBV-infected cells in an HLA-restricted manner.
Ebvallo (tabelecleucel) is indicated as monotherapy for treatment of adult and paediatric patients 2 years of age and older with relapsed or refractory Epstein-Barr virus positive post-transplant lymphoproliferative disease who have received at least one prior therapy.
Ebvallo™ (tabelecleucel) as a monotherapy for the treatment of adult and pediatric patients two years of age and older with relapsed or refractory Epstein‑Barr virus positive post‑transplant lymphoproliferative disease (EBV+ PTLD) who have received at least one prior therapy.
Ebvallo (tabelecleucel) is an allogeneic, EBV-specific T-cell immunotherapy which targets and eliminates EBV-infected cells in an HLA-restricted manner.
Under the amended terms, Atara will receive a milestone payment upon Tab-cel (tabelecleucel) EC approval and subsequent filing of the MAA transfer to Pierre Fabre in exchange for reduced tab-cel® royalties and supply price mark-up for Pierre Fabre.
Of 16 EBV+ PTLD patient, 15 received at least one dose of tab-cel. Overall, nine out of 15 tab-cel (tabelecleucel) treated patients achieved a response as assessed by treating physician, six CRs and three PR. Of nine responses, eight were observed of tab-cel.
FUJIFILM will provide Atara with access to the flexible capacity and specific capability needed to manufacture clinical and commercial-stage allogeneic cell therapies for its promising pipeline, including tabelecleucel (tab-cel®), ATA188, and allogeneic CAR T therapies.
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