Atara Biotherapeutics Inc. (NASDAQ: ATRA) announced that its partner Pierre Fabre Pharmaceuticals met with the U.S. Food and Drug Administration to discuss resubmitting the biologics license application for tabelecleucel following a complete response letter.

The FDA indicated that a single arm study using an appropriate historical control could serve as an adequate and well controlled study to provide safety and efficacy data supporting a future marketing application for tabelecleucel. The therapy is intended to treat relapsed or refractory Epstein-Barr virus positive post-transplant lymphoproliferative disease in adults and children two years of age and older following solid organ transplant or hematopoietic cell transplant.

Pierre Fabre Pharmaceuticals plans to submit an updated dataset with additional patients and longer follow-up from the pivotal Phase 3 ALLELE study as part of the resubmission plan being defined with the FDA, according to the press release.

"We appreciate the FDA's continued engagement with PFP and Atara, and we believe the Type A Meeting provided helpful alignment on the regulatory framework to resubmit," said Cokey Nguyen, president and chief executive officer of Atara.

Atara expects to provide a regulatory update in the third quarter as it continues to support Pierre Fabre's preparation of the resubmission. The company develops T-cell immunotherapies using its allogeneic Epstein-Barr virus T-cell platform for cancer and autoimmune diseases.