Atara claims first world approval for off-the-shelf T-cell therapy
Atara Biotherapeutics has become the first biotech to win regulatory approval for a T-cell therapy based on donated cells, rather than relying on cells harvested from patients and processed in a lab.
The company’s off-the-shelf or ‘allogeneic’ therapy tabelecleucel – now given the Ebvallo trade name – has been approved by the European Commission as a second-line treatment for a rare and potentially deadly cancer that afflicts some organ or bone marrow transplant recipients.
It can be used in adult and paediatric patients two years of age and older with relapsed or refractory Epstein‑Barr virus positive post‑transplant lymphoproliferative disease (EBV+ PTLD) who have received at least one prior therapy.
In some transplant patients, the immune-suppressing medicines used to prevent rejection can allow latent EBV infections to resurface and gather momentum, leading to life-threatening complications, including cancerous lesions that can lead to patient deaths in just weeks or months.
Ebvallo – which is based on T-cells that have been engineered to target and eliminate EBV-infected B cells – will be commercialised in Europe by French drugmaker Pierre Fabre. It was recommended for approval by the EMA’s human medicines committee in October.
https://pharmaphorum.com/news/atara-claims-first-world-approval-for-off-the-shelf-t-cell-therapy/
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