December 20, 2022: Atara Biotherapeutics, Inc announced that it has got marketing approval from the European Commission for Ebvallo™ (tabelecleucel) a monotherapy for the treatment of patients two years and older with relapsed or refractory Epstein‑Barr virus-positive post‑transplant lymphoproliferative disease (EBV+ PTLD)
Atara’s drug can be given to patients who’ve tried at least one other drug. For solid organ transplant patients, chemotherapy qualifies as a prior therapy.
The European Medicine Agency’s human medicines committee (CHMP) had already approved the therapy. Ebvallo will be available in all 27 European Union member states, as well as Iceland, Norway and Lichtenstein. Atara recently signed an amended deal with Pierre Fabre, a French multinational pharmaceutical, which allows it to receive a $30 million milestone payment for getting the EU approval.
Under the Ebvallo licensing pact, Pierre Fabre will have marketing rights to “all” commercialization and distribution efforts in Europe and “select other markets.” The French pharma will also handle medical and regulatory activities once Ebvallo marketing authorization is transferred from Atara, the companies said in the release.
“The approval of EbvalloTM in Europe is a medical breakthrough for patients with significant unmet need,” said Pascal Touchon, President and Chief Executive Officer 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.”
Apart from being the first allogeneic T-cell therapy, Ebvallo also marks the first green light in Europe for patients with the rare and deadly form of cancer EBV+ PTLD.
For Atara, the approval is a big win as earlier, it suffered a setback in a trial for T-Cell therapy due to a patient death. This ended its $670 million partnership with Bayer.
While a European nod doesn’t necessarily mean Ebvallo will win the FDA’s blessing, “it certainly can’t hurt as the FDA regularly pays attention to its regulatory counterpart and its decisions,” Mizuho Securities analysts wrote in a note to clients Monday, according to reports.
Atara said it will discuss its US application in the first quarter of 2023.
There is no pricing update on Ebvallo, though Atara has mentioned previous bookends between a CAR-T cell therapy (about $400,000) and Novartis’ gene therapy Zolgensma, which costs around $2.1 million.
