BeiGene's NDA for Zanubrutinib Gets Priority Review From FDA

FDA授予百济神州zanubrutinib新药申请优先审评资格

2019-08-23 13:06:55 Zacks

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Chinese biotech company, BeiGene, Ltd. BGNE announced that the FDA has accepted and granted priority review designation to its new drug application for its cancer candidate, zanubrutinib. A decision from the FDA is expected by Feb 27, 2020. The NDA is seeking approval for zanubrutinib as a treatment for patients with mantle cell lymphoma (MCL) — an aggressive form of lymphoma – in second or later line settings. In January, the candidate was granted Breakthrough Therapy designation for the same indication. Notably, FDA’s Breakthrough Therapy designation is granted to speed up the development and review of drugs that target serious or life-threatening conditions. The NDA was filed based on data from a pivotal phase II study in relapsed or refractory MCL patients and phase I/II study in patients with B-cell lymphomas. A glimpse of BeiGene's price trend so far this year reveals that it has gained 4.2% against the industry’s 1.1% decline. Data from the phase II study showed that treatment with zanubrutinib achieved overall response rate (the study’s primary endpoint) of 83.7% with complete response achieved in 77.9% of patients after a follow-up period of 18.4 months. Median progression-free-survival (PFS) achieved in the study was 19.1 months, with approximately 72.1% patients achieving 15 months of PFS. Meanwhile, data from the phase I/II showed that zanubrutinib was well tolerated and highly active in patients with MCL. BeiGene is also developing zanubrutinib in several other lymphoma indications. A late-stage study is evaluating the candidate in combination with Teva’s TEVA Treanda (bendamustine) plus Roche’s RHHBY Rituxan (rituximab) in patients with treatment-naive chronic lymphocytic leukemia (“CLL”) or small lymphocytic lymphoma (“SLL”). Zanubrutinib is already under review for r/r MCL and CLL/SLL indications in China. Apart from zanubrutinib, BeiGene is developing an anti-PD-1 antibody, tislelizumab, in multiple oncology indications including non-small cell lung cancer in first and later-line settings. Moreover, the company is developing a PARP inhibitor, pamiparib, for treating ovarian cancer. Currently, BeiGene generates revenues from the sales of cancer drug – Abraxane, Revlimid and Vidaza – in China, under a distribution license from Celgene CELG.
中国生物技术公司百济神州股份有限公司BeiGene宣布, FDA 已接受并授予其癌症候选药物zanubrutinib的新药申请优先审评资格。FDA 预计将于2020年2月27日做出决定。 NDA 正在寻求批准桑布鲁替尼作为治疗套细胞淋巴瘤( MCL )——一种侵袭性的淋巴瘤——患者的第二或以后行设置。1月,该候选人获得了相同适应症的突破性治疗指定。值得注意的是,美国食品和药物管理局的突破性治疗指定是为了加快开发和审查针对严重或威胁生命的药物。 NDA 是根据复发或难治 MCL 患者的关键 II 期研究和 B 细胞淋巴瘤患者的 I / II 期研究的数据归档的。 今年以来北基因股价走势的一瞥显示,相对于该行业1.1%的跌幅,该公司股价上涨了4.2%。 第二阶段研究的数据显示,使用桑布鲁替尼治疗的总有效率(研究的主要终点)为83.7%,在18.4个月的随访期后,77.9%的患者获得完全缓解。研究中的中位无进展生存期( PFS )为19.1个月,约72.1%的患者实现15个月的 PFS 。 同时, I / II 期的数据显示,桑布鲁替尼对 MCL 患者具有良好的耐受性和高度的活性。 贝金还在其他几个淋巴瘤适应症中开发桑布鲁替尼。一项后期研究正在评估候选人与梯瓦(Teva)的 TEVA Treanda ( bendamustin )联合罗氏(Roche)的 RHHBY Rituxan (利妥昔单抗)治疗单纯慢性淋巴细胞白血病( CLL )或小淋巴细胞性淋巴瘤( SLL )的患者。 Zanubibinib 已经在中国进行 r / r MCL 和 CLL / SLL 适应症的审查。 除了桑布鲁替尼,贝基因正在开发抗 PD-1抗体,蒂斯莱珠单抗,在包括非小细胞肺癌在内的多个肿瘤适应症的一线和后期设置。此外,该公司正在开发一种 PARP 抑制剂帕帕帕利巴,用于治疗卵巢癌。 目前, BeiGene 通过 CelgeneCELG 的经销许可,在中国销售抗癌药物 Abraxane 、 Revlimd 和 Vidada 产生收入。

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