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EMA Accepts Marketing Application for Atara Biotherapeutics' Tabelecleucel

NEW YORK – The European Medicines Agency on Tuesday accepted Atara Biotherapeutics' marketing authorization application for its allogeneic CAR T-cell therapy tabelecleucel for the treatment of Epstein-Barr virus-positive post-transplant lymphoproliferative disease.

The validation begins the review process by the EMA's Committee for Medicinal Products for Human Use, or CHMP. The EMA may make its decision based on CHMP's recommendation in the second half of 2022.

Tabelecleucel, or tab-cel, is being evaluated in an ongoing Phase III, registration-enabling study in adults and children with Epstein-Barr virus-positive post-transplant lymphoproliferative disease who have received at least one prior therapy following solid organ transplant or hematopoietic cell transplant. Early data from that trial, called ALLELE, showed a 50 percent objective response rate among 38 patients treated with tab-cel. Among the 19 responders, 11 had a duration of response longer than six months and the one-year survival rate was 89.2 percent.

Lymphoproliferative disease causes cells of the lymphatic system to grow excessively. Post-transplant lymphoproliferative disease is a type of cancer or lymphoma that may occur after bone marrow or organ transplant.

Atara is also studying tab-cel in other Epstein-Barr virus-positive hematologic and solid tumors, including in combination with pembrolizumab (Merck's Keytruda) as a treatment for nasopharyngeal carcinoma.

Last year, Atara began a Phase I study of another therapy, ATA2271, a mesothelin-targeting autologous CAR T-cell therapy that it is developing for the treatment of advanced mesothelioma. Also in 2020, Atara entered into a licensing deal with Bayer to jointly develop and manufacture ATA2271 and its other mesothelin-targeting candidates in solid tumors.