Atara: tab-cel CRL 관련 FDA Type A 미팅, 재제출 경로 확정

The FDA agreed that a single-arm study with a pre-specified historical control can serve as an adequate and well-controlled study to support resubmission of the tab-cel BLA. PFP plans to submit an updated ALLELE dataset with additional patients and longer follow-up plus supportive data. Atara expects a further regulatory update in Q3.

핵심 사실

제출: 2026년 5월 7일 PM 12:10
이벤트: 보완요구서한 (CRL)
방향: 중립
기업: ATRAAtara Biotherapeutics, Inc
자산: tabelecleucel
출처: SEC 8-K
신뢰도: 출처 확인
캘린더: FDA 심사 결정 (PDUFA) · 2026년 1월 10일 · 보완요구서한 (CRL)

출처 발췌

EX-99.1 2 atra-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 Atara Biotherapeutics Provides Regulatory Update on Tabelecleucel THOUSAND OAKS, Calif.--(BUSINESS WIRE)-- Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, today provided an update following the recent Type A meeting with the U.S. Food and Drug Administration (FDA) to discuss the Complete Response Letter (CRL) to the Biologics License Application (BLA) for tabelecleucel (tab-cel) held by our partner Pierre Fabre Pharmaceuticals, Inc. (PFP). PFP, with Atara’s support, had a productive meeting with the FDA and discussed a potential path forward to

SEC 8-K