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AUCATZYL is the first CAR T therapy approved by the FDA with no requirement for a REMS program (Risk Evaluation Mitigation Strategy)Approval based on FELIX clinical trial of obe-cel in adult patients with r/r B-ALLConference call to be held on November 11 at 08:30 am EST/13:30 pm BST: conference call participants should pre-register using the link at the bottom of this press release LONDON, Nov.

AUCATZYL是FDA批准的第一种CAR T疗法，无需REMS计划（风险评估缓解策略）批准，该计划基于11月11日上午08:30 EST/下午13:30 BST举行的obe cel成人r/r B-ALLConference call患者的FELIX临床试验。电话会议参与者应使用11月11日伦敦新闻稿底部的链接进行预注册。

08, 2024 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), an early-commercial stage biopharmaceutical company developing next-generation programmed T cell therapies, today announces the U.S. Food and Drug Administration (FDA) has granted marketing approval for AUCATZYL® (obecabtagene autoleucel) for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL).

2024年8月8日（环球通讯社）--Autolus Therapeutics plc（纳斯达克：AUTL）是一家开发下一代程序性T细胞疗法的早期商业化生物制药公司，今天宣布美国食品和药物管理局（FDA）已批准AUCATZYL®（obecabtagene autoleucel）用于治疗复发或难治性B细胞前体急性淋巴细胞白血病（r/r B-ALL）的成年患者。

“Adult ALL is an extremely aggressive cancer, and there is a high unmet medical need that exists in the treatment of patients with this disease once they relapse, where historically they suffer from poor outcomes,” said Elias Jabbour, MD, U.S. lead investigator of the FELIX study and professor of Leukemia, ALL Section Chief, at The University of Texas MD Anderson Cancer Center, Houston, Texas.  “This milestone approval, based on the demonstrated clinical benefit of AUCATZYL, brings new hope for adult patients with relapsed/refractory B-ALL.” AUCATZYL was approved by the FDA based on results from the FELIX clinical trial of obe-cel in adult patients with r/r B-ALL.

“成人ALL是一种极具侵袭性的癌症，一旦复发，这种疾病患者的治疗存在很大的未满足医疗需求，历史上他们的预后很差，”美国FELIX研究首席研究员、德克萨斯州休斯顿德克萨斯大学安德森癌症中心白血病教授Elias Jabbour博士说。“基于AUCATZYL已证明的临床益处，这一里程碑式的批准为复发/难治性B-ALL的成年患者带来了新的希望。”AUCATZYL是FDA根据obe cel在成年r/r B-ALL患者中的FELIX临床试验结果批准的。

In the morphological disease cohort, 94 patients received at least one infusion of AUCATZYL of which 65 patients had > 5% blasts in the bone marrow after screening and prior to the start of lymphodepletion therapy and received a conforming product, qualifying them as efficacy evaluable. In the.

在形态学疾病队列中，94名患者接受了至少一次AUCATZYL输注，其中65名患者在筛查后和开始淋巴清除治疗之前的骨髓中有>5%的原始细胞，并接受了合格的产品，使其具有可评估的疗效。在。