Atara says Pierre Fabre’s recent FDA meeting produced a clearer path to resubmit tabelecleucel, using updated Phase 3 data and a historical-control framework.
Atara Biotherapeutics said the FDA has outlined a potential path for resubmitting tabelecleucel after the agency’s complete response letter.
In a May 7 regulatory update, Atara said Pierre Fabre Pharmaceuticals recently held a Type A meeting with the FDA about the CRL for tabelecleucel, also known as tab-cel. The company said the FDA agreed that a single-arm study using an appropriate historical control could support a future marketing application.
Atara said Pierre Fabre plans to resubmit the application using updated data from the Phase 3 ALLELE study, including additional patients and longer follow-up.
The update gives the two companies a clearer regulatory route than before, though it does not mean approval is guaranteed. The FDA still has to review any resubmission, and Atara said it expects to provide another update later in 2026.
For investors, the key question now is whether the expanded dataset will be enough to satisfy the agency on a second pass.
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