Atara Biotherapeutics partner submits Type A meeting request to FDA

Atara Biotherapeutics (ATRA) announced that its partner Pierre Fabre Pharmaceuticals has submitted a request to the FDA for a Type A meeting. Pierre Fabre Pharmaceuticals, in partnership with Atara, submitted a briefing book to the FDA addressing the points from the complete response letter dated January 9, providing additional context and clarification that the ALLELE study was adequate, well-controlled, and sufficient to support the tabelecleucel biologics license application. In addition, the briefing book includes summaries of updated, longer-term efficacy data from ALLELE, additional supportive data from the tab-cel development program and post-marketing data in Europe that will be included in a potential resubmission. “With our partners at Pierre Fabre Pharmaceuticals, we are eager to engage in a constructive discussion with the FDA to reach a path forward for tabelecleucel,” said Cokey Nguyen, president and CEO of Atara. “The PTLD community, including physicians and patient advocacy groups have emphasized the urgent need for tabelecleucel and its ability to address a dire unmet medical need in this ultra-rare disease.”