Atara, Pierre Fabre Announce CHMP Adopts Positive Opinion Recommending Approval Of Ebvallo

(RTTNews) - Atara Biotherapeutics, Inc. (ATRA) and Pierre Fabre announced the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending the European Commission approval of Ebvallo as a monotherapy for 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. The CHMP positive opinion is based on results from the phase 3 ALLELE study.

The company said the EC's approval of the Ebvallo Marketing Authorization Application under exceptional circumstances is expected by the end of 2022.