The European Commission (EC) has for 鈥� Ebvallo (tabelecleucel) as a monotherapy to treat Epstein鈥態arr virus positive post鈥憈ransplant 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鈥檚 (EMA) positive opinion on Ebvallo in October.
The CHMP鈥檚 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鈥檚 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: 鈥淭he approval of Ebvallo in Europe is a medical breakthrough for patients with significant unmet need.
鈥淎s 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.鈥�
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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