Roche's Tecentriq Gets Japan's Nod for Small Cell Lung Cancer

罗氏Tecentriq日本获批治疗晚期小细胞肺癌

2019-08-26 14:03:00 Zacks

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Roche RHHBY announced that its subsidiary, Chugai, has obtained regulatory approval for its immuno-oncology drug, Tecentriq, in Japan for the treatment of extensive-stage small cell lung cancer . The approval was based on the positive results from the phase I/III IMpower133 study. Tecentriq in combination with chemotherapy met the primary endpoint of overall survival (OS) compared with chemotherapy alone in the intent to treat (ITT) analysis. The study also met co-primary endpoint of progression-free survival (PFS). Per the company, Tecentriq is the first approved cancer immunotherapy for extensive-stage SCLC in Japan, and hence a strong uptake is expected.  Lung cancer is the leading cause of cancer deaths. SCLC accounts for 10-15% of all lung cancer cases in Japan. We remind investors that the drug is indicated for unresectable, advanced or recurrent non-small cell lung cancer (NSCLC) in Japan. It was also approved for the treatment of untreated unresectable, advanced or recurrent non-squamous NSCLC in December 2018. Additionally, a supplementary application for breast cancer was submitted in December 2018. Roche has an extensive development program for Tecentriq, including multiple ongoing and planned phase III studies, across lung, genitourinary, skin, breast, gastrointestinal, gynecological, and head and neck cancers. The company currently has five approved drugs (Tarceva, Avastin and Tecentriq, among others) to treat certain kinds of lung cancer and more than 10 candidates in the pipeline. Last week, the FDA approved Rozlytrek (entrectinib) for the treatment of adults with ROS1-positive, metastatic NSCLC. Roche’s stock has gained 11.2% in the year so far against the industry’s decline of 1.2%. However, competition is stiff in the lung cancer market. Immuno-oncology therapies like Merck’s MRK Keytruda, AstraZeneca’s AZN Imfinzi and Bristol-Myers’ BMY Opdivo are approved for various types of lung cancer.
罗氏(Roche) RHHBY 宣布,其子公司 Chugai 已获得其免疫肿瘤药物 Tecentriq 在日本用于治疗广泛阶段小细胞肺癌的监管批准。 这项批准是基于第一/三期 IMpower133研究的积极结果。与单纯化疗相比, Tecentriq 联合化疗达到了总生存期( OS )的主要终点。这项研究还达到了无进展生存( PFS )的共同主要终点。 根据该公司, Tecentriq 是第一个批准的癌症免疫疗法广泛阶段的 SCLC 在日本,因此预计强烈的摄取。肺癌是导致癌症死亡的主要原因。SCLC 占日本所有肺癌病例的10-15%。 我们提醒投资者,该药物在日本用于不可切除、晚期或复发的非小细胞肺癌( NSCLC )。2018年12月还批准用于治疗未经治疗的不能切除、晚期或复发的非鳞状细胞非小细胞肺癌(NSCLC)。此外,2018年12月提交了乳腺癌补充申请。 罗氏(Roche)公司为 Tecentriq 公司制定了广泛的发展计划,包括多项正在进行和计划进行的 III 期研究,涉及肺癌、泌尿生殖道、皮肤、乳腺、胃肠道、妇科和头颈癌。 该公司目前拥有5个批准的药物( Tarceva 、 Avastin 和 Tecentriq 等),用于治疗某些类型的肺癌,还有10多个候选药物正在准备中。 上周, FDA 批准 Rozleytrek ( entctinib )治疗成人 ROS1阳性转移非小细胞非小细胞肺癌(NSCLC)。 今年迄今,罗氏(Roche)的股价已上涨11.2%,而该行业的跌幅为1.2%。 然而,肺癌市场竞争激烈。默克(Merck)公司的 MRK 可瑞达(Keytruda)、阿斯利康(AstraZeneca)公司的 AZN Imfinzi 和百时美施贵宝公司的 BMY Opdivo 等免疫肿瘤疗法被批准用于各种类型的肺癌。

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