Pierre Fabre to commercialize and distribute
the first approved allogeneic T-cell immunotherapy in Europe
Following transfer of the European Commission marketing authorization from Atara Biotherapeutics, Pierre Fabre is to lead launch and commercialization activities for Ebvallo® (tabelecleucel) in Europe
The french group Pierre Fabre and Atara Biotherapeutics, a californian biotech dedicated to T-cell immunotherapy, have announced the transfer of the European Commission (EC) marketing authorization (MA) for Ebvallo® (tabelecleucel) for patients with relapsed or refractory Epstein‑Barr virus positive post‑transplant lymphoproliferative disease (EBV+ PTLD) from Atara to Pierre Fabre. Ebvallo® is an allogeneic, EBV-specific T-cell immunotherapy which targets and eliminates EBV-infected cells in an HLA-restricted manner.
On December 16, 2022, the EC granted marketing authorization for Ebvallo® as a monotherapy for the treatment of adult and pediatric patients two years of age and older with relapsed or refractory EBV+ PTLD who have received at least one prior therapy. For solid organ transplant patients, prior therapy includes chemotherapy, unless chemotherapy is inappropriate. The EC marketing authorization is based on results from the pivotal Phase 3 ALLELE study and additional supportive studies. Based on these results, Ebvallo® demonstrated a favorable risk-benefit profile.
“Following the EU approval of Ebvallo®, Atara is the first company to obtain regulatory approval for an allogeneic T-cell immunotherapy, reinforcing the significant advantages of our EBV platform and approach” said Pascal Touchon, President and CEO of Atara. Pierre Fabre will lead all commercialization, distribution, medical and regulatory activities in Europe, Middle East, Africa and other selected markets. The french group is planning to launch Ebvallo® in the first European countries during Q1 2023.
Atara will continue to be responsible for the pivotal ALLELE study in PTLD and the Phase 2 multi-cohort study, which is evaluating Ebvallo® in additional patient populations. Atara retains full rights to Ebvallo® in other major markets, including North America, Asia Pacific, and Latin America.
11/02/2023
Pierre Fabre to commercialize and distribute the first approved allogeneic T-cell immunotherapy in Europe
Pierre Fabre to commercialize and distribute
the first approved allogeneic T-cell immunotherapy in Europe
Following transfer of the European Commission marketing authorization from Atara Biotherapeutics, Pierre Fabre is to lead launch and commercialization activities for Ebvallo® (tabelecleucel) in Europe
The french group Pierre Fabre and Atara Biotherapeutics, a californian biotech dedicated to T-cell immunotherapy, have announced the transfer of the European Commission (EC) marketing authorization (MA) for Ebvallo® (tabelecleucel) for patients with relapsed or refractory Epstein‑Barr virus positive post‑transplant lymphoproliferative disease (EBV+ PTLD) from Atara to Pierre Fabre. Ebvallo® is an allogeneic, EBV-specific T-cell immunotherapy which targets and eliminates EBV-infected cells in an HLA-restricted manner.
On December 16, 2022, the EC granted marketing authorization for Ebvallo® as a monotherapy for the treatment of adult and pediatric patients two years of age and older with relapsed or refractory EBV+ PTLD who have received at least one prior therapy. For solid organ transplant patients, prior therapy includes chemotherapy, unless chemotherapy is inappropriate. The EC marketing authorization is based on results from the pivotal Phase 3 ALLELE study and additional supportive studies. Based on these results, Ebvallo® demonstrated a favorable risk-benefit profile.
“Following the EU approval of Ebvallo®, Atara is the first company to obtain regulatory approval for an allogeneic T-cell immunotherapy, reinforcing the significant advantages of our EBV platform and approach” said Pascal Touchon, President and CEO of Atara. Pierre Fabre will lead all commercialization, distribution, medical and regulatory activities in Europe, Middle East, Africa and other selected markets. The french group is planning to launch Ebvallo® in the first European countries during Q1 2023.
Atara will continue to be responsible for the pivotal ALLELE study in PTLD and the Phase 2 multi-cohort study, which is evaluating Ebvallo® in additional patient populations. Atara retains full rights to Ebvallo® in other major markets, including North America, Asia Pacific, and Latin America.
11/02/2023
COMMENTS ARE OFF THIS POST