World’s first approval of an allogeneic T-cell immunotherapy

The European Commission (EC) has granted the first approval of an allogeneic T-cell immunotherapy globally, a marketing authorisation for Ebvallo™ (tabelecleucel) for patients over two years of old with relapsed or refractory Epstein‑Barr virus positive post‑transplant lymphoproliferative disease (EBV+ PTLD) who have received at least one prior therapy. For solid organ transplant patients, prior therapy includes chemotherapy unless chemotherapy is inappropriate.

“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 the broader cell therapy field.” explained Pascal Touchon, President and Chief Executive Officer of Atara Biotherapeutics, the company who produced the therapy.

The positive opinion that led to the world’s first approval of an allogeneic T-cell immunotherapy

The approval follows the Committee for Medicinal Products for Human Use (CHMP)’s positive opinion given in October 2022 and is applicable to all 27 European Union Member States plus Iceland, Norway, and Liechtenstein. The CHMP positive opinion is based on results from the pivotal Phase III ALLELE study, which showed Ebvallo^TM demonstrated a favorable risk-benefit profile.

Under a previously announced License Agreement with Atara, Pierre Fabre will lead all commercialisation and distribution activities in Europe and select other markets, in addition to medical and regulatory activities following the transfer of the Ebvallo^TM Marketing Authorization Application (MAA) from Atara to Pierre Fabre.

Touchon concluded: “The approval of [allogeneic T-cell immunotherapy] Ebvallo^TM in Europe is a medical breakthrough for patients with significant unmet need.”

Ebvallo^TM has orphan designation in Europe.