First allogeneic cancer immunotherapy hits market

On December 20^th, the European Commission approved Tabelecleucel (Ebvallo^TM) as a monotherapy for the treatment of adult and paediatric patients who have relapsed or are resistant to at least one previous therapy for Epstein Barr virus-positive posttransplant lymphoproliferative disorder (EBV+ PTLD). EBV+ PTLD is a rare, severe, and possibly fatal haematologic malignancy that develops after transplantation when a patient’s T-cell immune response is weakened by immunosuppression. The allogeneic T-cell immunotherapy from Atara Biotherapeutics Inc. is a first-in-class treatment as it harnesses T-cells from healthy donors, unlike autologous cell therapies such as Bristol Myers Squibb’s Abecma and Breyanzi and Gilead’s Yescarta and Tecartus.

The Committee for Medical Products for Human Use (CMHP) recommended EU market authorisation for  tabelecleucel under exceptional circumstances on October 13^th. Atara is to receive a $30m milestone payment for obtaining EU clearance under a recently modified commercialization agreement with Pierre Fabre. Following the transfer of the tabelecleucel MAA (Marketing Authorization Application) from Atara to Pierre Fabre, the French healthcare company will lead all commercialiSation and distribution activities in Europe and select other markets, as well as medical and regulatory activities.

“The approval of Ebvallo^TM in Europe is a medical breakthrough for patients with significant unmet need,” said Pascal Touchon, President, and CEO of Atara. “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, our European partner, Pierre Fabre, and for the broader cell therapy field.”