The European Commission (EC) has granted marketing authorization for Atara Biotherapeutics’ Ebvallo (tabelecleucel) as a monotherapy to treat Epstein‑Barr virus positive post‑transplant lymphoproliferative disease (EBV+ PTLD) patients.
Ebvallo is an off-the-shelf, allogeneic T-cell immunotherapy, which is indicated to treat relapsed or refractory EBV+ PTLD adult and paediatric patients aged two years and above who have previously received at least one therapy.
Atara Biotherapeutics stated that the prior therapy for solid organ transplant patients includes chemotherapy unless chemotherapy is not suitable.
The regulatory approval follows the Committee for Medicinal Products for Human Use (CHMP) of European Medicines Agency’s (EMA) positive opinion on Ebvallo in October.
The CHMP’s positive opinion is applicable to all 27 European Union member states along with Liechtenstein, Iceland, and Norway.
It is based on the data obtained from the pivotal Phase III ALLELE study, which assessed Ebvallo’s efficacy and safety to treat EBV+ PTLD in solid organ transplant (SOT) and hematopoietic cell transplant (HCT) after failure of initial treatment.
The immunotherapy showed favourable risk-benefit profile in this study.
Atara president and CEO Pascal Touchon said: “The approval of Ebvallo in Europe is a medical breakthrough for patients with significant unmet need.
“As the first allogeneic, or donor-derived, T-cell immunotherapy to receive approval from any regulatory agency in the world, this marks a historic moment for Atara, our European partner, Pierre Fabre, and for the broader cell therapy field.”
Under a previously announced license deal with the company, Pierre Fabre will be responsible for all commercialisation and distribution activities of Ebvallo in Europe as well as other selected markets after transferring the marketing authorization application (MAA) to the company from Atara.
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