The European Commission has given the green light to the marketing of Ebvallo, a new therapy for patients with a rare hematological malignancy, said in a press release the French laboratory Pierre Fabre, which will market it.
Ebvallo is intended for patients suffering from “LPT EBV+”, an acute and life-threatening haematological, i.e. blood cell, malignancy which can occur after transplantation.
World's first approval of T-cell immunotherapy
This authorization is the first worldwide approval of an immunotherapy with T lymphocytes (the essential cells of the immune system) using cells from a donor, argues Pierre Fabre.
Pierre Fabre will direct marketing and distribution activities in Europe for this treatment, developed by the American laboratory Atara Biotherapeutics.
This decision "represents a major medical advance for patients with significant unmet medical needs," said Pascal Touchon, CEO of Atara, quoted in the press release.
Ebvallo has received orphan drug designation in Europe.
This designation is reserved for medicinal products intended for the treatment of rare diseases (affecting no more than five in 10,000 people in the EU), which cause a threat to life or chronic disability.
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