Atara Biotherapeutics saw its shares climb 40% after the company said its partner, Pierre Fabre Pharmaceuticals, received guidance from the U.S. Food and Drug Administration on the pathway to resubmit a biologics license application for the T-cell therapy tabelecleucel.
The FDA conveyed that a single-arm study, when paired with an appropriate historical control, could qualify as an adequate and well-controlled study to provide the safety and efficacy data necessary to support a future marketing application for tabelecleucel. The therapy targets relapsed or refractory Epstein-Barr virus positive post-transplant lymphoproliferative disease in adults and in children aged two years and older who have undergone either solid organ transplant or hematopoietic cell transplant.
This guidance follows a previous complete response letter issued to the program. Pierre Fabre met with FDA officials to discuss the resubmission pathway and the agency’s feedback is intended to inform the next filing. As part of the plan being worked out with the FDA, Pierre Fabre intends to submit an updated dataset that incorporates additional patients and extends follow-up from the pivotal Phase 3 ALLELE study.
"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 said it will continue to support Pierre Fabre as the partner prepares the resubmission and that the company expects to provide a regulatory update in the third quarter. The firm develops T-cell immunotherapies based on an allogeneic Epstein-Barr virus T-cell platform intended for oncology and autoimmune indications.
The FDA’s acceptance of a single-arm study supplemented by historical controls specifies the type of evidence the agency views as potentially sufficient for a marketing application in this indication, and it frames the dataset Pierre Fabre has signaled it will assemble for resubmission. The company’s forthcoming regulatory update in the third quarter will reflect progress on that coordinated resubmission effort.
No additional timelines for the resubmission were specified beyond the planned third-quarter regulatory update, and the companies are defining the resubmission plan with the agency based on the additional patients and longer follow-up from ALLELE that Pierre Fabre intends to provide.