Atara Biotherapeutics Provides Regulatory Update on Tabelecleucel

Atara Biotherapeutics said a recent Type A meeting between its partner Pierre Fabre and the U.S. Food and Drug Administration gave the company a clearer path to resubmit tabelecleucel.

In its update, Atara said the FDA indicated that a single-arm study supported by an appropriate historical control could be sufficient to support a future marketing application. The company said Pierre Fabre plans to use updated Phase 3 ALLELE data, with longer follow-up and additional patients, in the resubmission package.

The update follows the Complete Response Letter tied to the tabelecleucel biologics license application.

Atara did not give a filing date in the statement, and the next formal timing signal is likely to come in a later quarterly update. For now, the company says the meeting clarified the regulatory path but does not remove the need for a successful resubmission and FDA review.