EC nod for Ebvallo as first ever therapy for adults and children with EBV+ PTLD

The European Commission (EC) has granted marketing authorization for Ebvallo (tabelecleucel)vas a monotherapy for 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. For solid organ transplant patients, prior therapy includes chemotherapy unless chemotherapy is inappropriate.

The EC nod was granted to US biotech Atara Biotherapies (Nasdaq: ATRA), whose shares edged up 3.4% to $3.64 in pre-market trading.

The approval follows a positive opinion in October by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) and applies to all 27 European Union member states plus Iceland, Norway and Liechtenstein. The CHMP positive opinion is based on results from the pivotal Phase III ALLELE study, in which Ebvallo demonstrated a favorable risk-benefit profile.