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Atara's Ebvallo Receives European Commission Approval For Adults And Children With EBV+ PTLD
(RTTNews) - Atara Biotherapeutics, Inc. (ATRA) and French healthcare company Pierre Fabre announced Monday that the European Commission (EC) has granted marketing authorization for Ebvallo (tabelecleucel) as a monotherapy for the 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 approval follows a positive opinion in October by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) and is applicable to all 27 European Union member states plus Iceland, Norway, and Liechtenstein.
The CHMP positive opinion is based on results from the pivotal Phase 3 ALLELE study. In this study, Ebvallo demonstrated a favorable risk-benefit profile.
EBV+ PTLD is a rare, acute, and potentially deadly hematologic malignancy that occurs after transplantation when a patient's T-cell immune response is compromised by immunosuppression.
Under a previously announced License Agreement with Atara, Pierre Fabre will lead all commercialization and distribution activities in Europe and select other markets, in addition to medical and regulatory activities following the transfer of the Ebvallo Marketing Authorization Application (MAA) to Pierre Fabre from Atara.
Ebvallo has orphan designation in Europe.
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