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Distributed by the Pierre Fabre laboratory, Ebvallo (tabelecleucel) has received the green light from the European Commission for its marketing. This treatment was designed to fight against a rare hematological malignancy, “LPT EBV+”.
The European Commission authorized the marketing of the Ebvallo treatment, developed by the American laboratory Atara Biotherapeutics. The Pierre Fabre laboratory will lead marketing and distribution activities in Europe. This is an innovative treatment – T cell immunotherapy – against a rare malignant hematological disease, post-transplant lymphoma and Epsetin-Barrque virus or “LPT EBV+”.
What is LPT EBV+?
This rare hematological malignancy affects some people after transplantation (such as allogeneic stem cell transplants – HSCs – and solid organ transplants – SOTs) when the patient’s T-cell immune response is compromised by immunosuppression. It is an acute disease affecting blood cells, potentially fatal and without treatment that has demonstrated significant efficacy.
Poor median survival of 0.7 months for HSC allograft and 4.1 months for SOT is reported in patients with EBV LPT+ for which the reference treatment has failed, which underlines the need to develop new therapeutic solutions.
First marketing authorization worldwide
This decision “represents a major medical advance for patients with significant unmet medical needs” according to Pascal Touchon, CEO of Atara. This marketing authorization is the first worldwide approval of a T cell immunotherapy using donor cells. To issue this favorable opinion, the CHMP has based on the results of thepivotal phase III ALLELE study. In this study, Ebvallo® demonstrated a favorable benefit-risk profile.
Finally, it should be noted that Ebvallo has received the designation of “orphan drug” in Europe, reserved for drugs intended for the treatment of rare diseases – affecting no more than five people out of 10,000 in the European Union – which pose a threat for life or chronic disability.