Atara receives first drug approval
Thousand Oaks-based Atara Biotherapeutics announced on Dec. 19 that the European Commission has approved its drug, Ebvallo.
Ebvallo, also known as tabelecleucel, has been Atara’s main product development in its pipeline since 2015. It is the first time Atara has received approval for one of its treatments.
The drug is 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, who have received at least one prior therapy.
Essentially, PTLD is the overproduction and spread of too many white blood cells. This can cause complications from benign enlargement of organs or tissues to the actual development of cancerous forms of lymphoma.
Should a person receive a cancer diagnosis and the first form or treatment doesn’t work, such as chemotherapy, then Ebvallo could be supplemented to try to help the patient.
Ebvallo is an allogeneic, EBV-specific T-cell immunotherapy that targets and eliminates EBV-infected cells. It is the first of its kind allogeneic T-cell therapy.
The approval comes after Ebvallo received a positive opinion in October from the Committee for Medicinal Products for Human Use of the European Medicines Agency and is applicable to all 27 European Union member states plus Iceland, Norway, and Liechtenstein.
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 Ebvallo’s Marketing Authorization Application from Atara to Pierre, the company said in a statement.
“The approval of Ebvallo in Europe is a medical breakthrough for patients with significant unmet needs,” Pascal Touchon, President and CEO of Atara, said in a news release.
“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.