FDA Approves Genentech’s Tecentriq as Adjuvant Treatment for Certain People With Early Non-Small Cell Lung Cancer

FDA批准基因泰克的Tecentriq作为某些早期非小细胞肺癌患者的辅助治疗

2021-10-16 01:30:07 BioSpace

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– Tecentriq is the first and only cancer immunotherapy approved for treatment of NSCLC in the adjuvant setting – – Approval based on the Phase III IMpower010 study showing adjuvant Tecentriq improved disease-free survival by more than one-third in PD-L1-positive Stage II-IIIA lung cancer, compared with best supportive care – SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, Inc., a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved Tecentriq® (atezolizumab) as adjuvant treatment following surgery and platinum-based chemotherapy for adults with Stage II-IIIA non-small cell lung cancer (NSCLC) whose tumors express PD-L1≥1%, as determined by an FDA-approved test. “Tecentriq is now the first and only cancer immunotherapy available for adjuvant treatment of NSCLC, introducing a new era where people diagnosed with early lung cancer may have the opportunity to receive immunotherapy to increase their chances for cure,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “Today’s landmark approval gives physicians and patients a new way to treat early lung cancer that has the potential to significantly reduce risk of cancer recurrence, after more than a decade with limited treatment advances in this setting.” “Too many patients with early-stage lung cancer experience disease recurrence following surgery. Now, the availability of immunotherapy following surgery and chemotherapy offers many patients new hope and a powerful new tool to reduce their risk of cancer relapse,” said Bonnie Addario, Co-founder and Chair, GO2 Foundation for Lung Cancer. “With this approval, it is more important than ever to screen for lung cancer early and test for PD-L1 at diagnosis to help bring this advance to the people who can benefit.” The approval is based on results from an interim analysis of the Phase III IMpower010 study that showed treatment with Tecentriq following surgery and platinum-based chemotherapy reduced the risk of disease recurrence or death by 34% (hazard ratio [HR]=0.66, 95% CI: 0.50-0.88) in people with Stage II-IIIA (UICC/AJCC 7th edition) NSCLC whose tumors express PD-L1≥1%, compared with best supportive care (BSC). Safety data for Tecentriq were consistent with its known safety profile and no new safety signals were identified. Fatal and serious adverse reactions occurred in 1.8% and 18%, respectively, of patients receiving Tecentriq. The most frequent serious adverse reactions (>1%) were pneumonia (1.8%), pneumonitis (1.6%), and pyrexia (1.2%). The review of this application was conducted under the FDA’s Project Orbis initiative, which provides a framework for concurrent submission and review of oncology medicines among international partners. According to the FDA, collaboration among international regulators may allow patients with cancer to receive earlier access to products in other countries where there may be significant delays in regulatory submissions. Simultaneous applications were submitted to regulators in the United States, Switzerland, the United Kingdom, Canada, Brazil and Australia under Project Orbis. Additionally, the FDA reviewed and approved the supplemental application under its Real-Time Oncology Review pilot program, which aims to explore a more efficient review process to ensure safe and effective treatments are available to patients as early as possible. Tecentriq has previously shown clinically meaningful benefit in various types of lung cancer, with six currently approved indications in the U.S. In addition to becoming the first approved cancer immunotherapy for adjuvant NSCLC, Tecentriq was also the first approved cancer immunotherapy for front-line treatment of adults with extensive-stage small cell lung cancer (SCLC) in combination with carboplatin and etoposide (chemotherapy). Tecentriq also has four approved indications in advanced NSCLC as either a single agent or in combination with targeted therapies and/or chemotherapies. Tecentriq is available in three dosing options, providing the flexibility to choose administration every two, three or four weeks. Genentech has an extensive development program for Tecentriq, including multiple ongoing and planned Phase III studies across different lung, genitourinary, skin, breast, gastrointestinal, gynecological, and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines, as well as studies in metastatic, adjuvant and neoadjuvant settings across various tumor types. About the IMpower010 study IMpower010 is a Phase III, global, multicenter, open-label, randomized study evaluating the efficacy and safety of Tecentriq compared with BSC, in participants with Stage IB-IIIA NSCLC (UICC/AJCC 7th edition), following surgical resection and up to 4 cycles of adjuvant cisplatin-based chemotherapy. The study randomized 1,005 people with a ratio of 1:1 to receive either Tecentriq for 1 year (16 cycles), unless disease recurrence or unacceptable toxicity occurred, or BSC. The primary endpoint is investigator-determined DFS in the PD-L1-positive Stage II-IIIA, all randomized Stage II-IIIA and intent-to-treat (ITT) Stage IB-IIIA populations. Key secondary endpoints include overall survival (OS) in the overall study population, ITT Stage IB-IIIA NSCLC. About lung cancer According to the American Cancer Society, it is estimated that more than 235,000 Americans will be diagnosed with lung cancer in 2021. NSCLC accounts for 80-85% of all lung cancers and approximately 50% of patients diagnosed with NSCLC are diagnosed with early-stage (Stages I and II) or locally advanced (Stage III) disease. Today, about half of all people with early lung cancer still experience a cancer recurrence following surgery. Treating lung cancer early, before it has spread, may help prevent the disease from returning and provide people with the best opportunity for a cure. About Tecentriq® (atezolizumab) Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1. Tecentriq is designed to bind to PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the re-activation of T cells. Tecentriq may also affect normal cells. Tecentriq U.S. Indications Tecentriq is a prescription medicine used to treat adults with: A type of lung cancer called non-small cell lung cancer (NSCLC). TECENTRIQ may be used alone as a treatment for their lung cancer: to help prevent their lung cancer from coming back after their tumor(s) has been removed by surgery and they have received platinum-based chemotherapy, and they have stage 2 to 3A NSCLC (patients should talk to their healthcare provider about what these stages mean), and their cancer tests positive for “PD-L1”. to help prevent their lung cancer from coming back after their tumor(s) has been removed by surgery and they have received platinum-based chemotherapy, and they have stage 2 to 3A NSCLC (patients should talk to their healthcare provider about what these stages mean), and their cancer tests positive for “PD-L1”. Tecentriq may be used alone as their first treatment when their lung cancer: has spread or grown, and their cancer tests positive for “high PD-L1”, and their tumor does not have an abnormal “EGFR” or “ALK” gene has spread or grown, and their cancer tests positive for “high PD-L1”, and their tumor does not have an abnormal “EGFR” or “ALK” gene Tecentriq may be used with the medicines bevacizumab, paclitaxel, and carboplatin as their first treatment when their lung cancer: has spread or grown, and is a type called “non-squamous NSCLC,” and their tumor does not have an abnormal “EGFR” or “ALK” gene has spread or grown, and is a type called “non-squamous NSCLC,” and their tumor does not have an abnormal “EGFR” or “ALK” gene Tecentriq may be used with the medicines paclitaxel protein-bound and carboplatin as their first treatment when their lung cancer: has spread or grown, and is a type called “non-squamous NSCLC,” and their tumor does not have an abnormal “EGFR” or “ALK” gene has spread or grown, and is a type called “non-squamous NSCLC,” and their tumor does not have an abnormal “EGFR” or “ALK” gene Tecentriq may also be used when their lung cancer: has spread or grown, and they have tried chemotherapy that contains platinum, and it did not work or is no longer working if their tumor has an abnormal “EGFR” or “ALK” gene, they should have also tried an FDA-approved therapy for tumors with these abnormal genes, and it did not work or is no longer working has spread or grown, and they have tried chemotherapy that contains platinum, and it did not work or is no longer working if their tumor has an abnormal “EGFR” or “ALK” gene, they should have also tried an FDA-approved therapy for tumors with these abnormal genes, and it did not work or is no longer working A type of lung cancer called small cell lung cancer (SCLC). Tecentriq may be used with the chemotherapy medicines carboplatin and etoposide as their first treatment when their lung cancer: is a type called “extensive-stage small cell lung cancer,” which means that it has spread or grown is a type called “extensive-stage small cell lung cancer,” which means that it has spread or grown It is not known if Tecentriq is safe and effective in children. Important Safety Information What is the most important information about Tecentriq? Tecentriq can cause the immune system to attack normal organs and tissues in any area of the body and can affect the way they work. These problems can sometimes become severe or life threatening and can lead to death. Patients can have more than one of these problems at the same time. These problems may happen anytime during their treatment or even after their treatment has ended. Patients should call or see their healthcare provider right away if they develop any new or worse signs or symptoms, including: Lung problems cough shortness of breath chest pain Intestinal problems diarrhea (loose stools) or more frequent bowel movements than usual stools that are black, tarry, sticky, or have blood or mucus severe stomach-area (abdomen) pain or tenderness Liver problems yellowing of the skin or the whites of the eyes severe nausea or vomiting pain on the right side of their stomach area (abdomen) dark urine (tea colored) bleeding or bruising more easily than normal Hormone gland problems headaches that will not go away or unusual headaches eye sensitivity to light eye problems rapid heartbeat increased sweating extreme tiredness weight gain or weight loss feeling more hungry or thirsty than usual urinating more often than usual hair loss feeling cold constipation their voice gets deeper dizziness or fainting changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness Kidney problems decrease in their amount of urine blood in their urine swelling of their ankles loss of appetite Skin problems rash itching skin blistering or peeling painful sores or ulcers in mouth or nose, throat, or genital area fever or flu-like symptoms swollen lymph nodes Problems can also happen in other organs. These are not all of the signs and symptoms of immune system problems that can happen with Tecentriq. Patients should call or see their healthcare provider right away for any new or worse signs or symptoms, including: Chest pain, irregular heartbeat, shortness of breath, or swelling of ankles Confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs Double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight Persistent or severe muscle pain or weakness, muscle cramps Low red blood cells, bruising Infusion reactions that can sometimes be severe or life-threatening. Signs and symptoms of infusion reactions may include: chills or shaking itching or rash flushing shortness of breath or wheezing dizziness feeling like passing out fever back or neck pain Complications, including graft-versus-host disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. These complications may happen if patients undergo transplantation either before or after being treated with Tecentriq. A healthcare provider will monitor for these complications. Getting medical treatment right away may help keep these problems from becoming more serious. A healthcare provider will check patients for these problems during their treatment with Tecentriq. A healthcare provider may treat patients with corticosteroid or hormone replacement medicines. A healthcare provider may also need to delay or completely stop treatment with Tecentriq if patients have severe side effects. Before receiving Tecentriq, patients should tell their healthcare provider about all of their medical conditions, including if they: have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus have received an organ transplant have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic) have received radiation treatment to their chest area have a condition that affects their nervous system, such as myasthenia gravis or Guillain-Barré syndrome are pregnant or plan to become pregnant. Tecentriq can harm an unborn baby. Patients should tell their healthcare provider right away if they become pregnant or think they may be pregnant during treatment with Tecentriq. Females who are able to become pregnant: A healthcare provider should do a pregnancy test before they start treatment with Tecentriq They should use an effective method of birth control during their treatment and for at least 5 months after the last dose of Tecentriq A healthcare provider should do a pregnancy test before they start treatment with Tecentriq They should use an effective method of birth control during their treatment and for at least 5 months after the last dose of Tecentriq are breastfeeding or plan to breastfeed. It is not known if Tecentriq passes into the breast milk. Patients should not breastfeed during treatment and for at least 5 months after the last dose of Tecentriq Patients should tell their healthcare provider about all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. The most common side effects of Tecentriq when used alone include: feeling tired or weak decreased appetite nausea cough shortness of breath The most common side effects of Tecentriq when used in lung cancer with other anti-cancer medicines include: feeling tired or weak nausea hair loss constipation diarrhea decreased appetite Tecentriq may cause fertility problems in females, which may affect the ability to have children. Patients should talk to their healthcare provider if they have concerns about fertility. These are not all the possible side effects of Tecentriq. Patients should ask their healthcare provider or pharmacist for more information about the benefits and side effects of Tecentriq. Report side effects to the FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch. Report side effects to Genentech at 1-888-835-2555. Please see http://www.Tecentriq.com for full Prescribing Information and additional Important Safety Information. About Genentech in cancer immunotherapy Genentech has been developing medicines to redefine treatment in oncology for more than 35 years, and today, realizing the full potential of cancer immunotherapy is a major area of focus. With more than 20 immunotherapy molecules in development, Genentech is investigating the potential benefits of immunotherapy alone, and in combination with various chemotherapies, targeted therapies and other immunotherapies with the goal of providing each person with a treatment tailored to harness their own unique immune system. In addition to Genentech’s approved PD-L1 checkpoint inhibitor, the company’s broad cancer immunotherapy pipeline includes other checkpoint inhibitors, individualized neoantigen therapies and T cell bispecific antibodies. For more information visit http://www.gene.com/cancer-immunotherapy. About Genentech in lung cancer Lung cancer is a major area of focus and investment for Genentech, and we are committed to developing new approaches, medicines and tests that can help people with this deadly disease. Our goal is to provide an effective treatment option for every person diagnosed with lung cancer. We currently have five approved medicines to treat certain kinds of lung cancer and more than 10 medicines being developed to target the most common genetic drivers of lung cancer or to boost the immune system to combat the disease. About Genentech Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com. View source version on businesswire.com: https://www.businesswire.com/news/home/20211015005506/en/ Media Contact: Elizabeth Hughes (650) 467-6800 Advocacy Contact: David Cooling (202) 713-0083 Investor Contacts: Loren Kalm (650) 467-8737 Karl Mahler 011 41 61 687 8503 Source: Genentech View this news release online at: http://www.businesswire.com/news/home/20211015005506/en
-Tecentriq是第一个也是唯一一个被批准在辅助环境下治疗非小细胞肺癌的癌症免疫疗法- -基于III期IMpower010研究的批准,该研究显示,与最佳支持治疗相比,佐剂Tecentriq在PD-L1阳性的II-IIIA期肺癌中提高了三分之一以上的无病生存率- 加州南三藩市--(商业电)--罗氏集团成员基因泰克公司今天宣布,美国食品药品监督管理局(FDA)已批准Tecentriq®(atezolizumab)作为手术和铂类化疗后的辅助治疗,用于由FDA批准的测试确定的肿瘤表达PD-L1≥1%的II-IIIA期非小细胞肺癌(NSCLC)的成人。 首席医疗官兼全球产品开发负责人、医学博士Levi Garraway说:“Tecentriq现在是第一种也是唯一一种可用于辅助治疗非小细胞肺癌的癌症免疫疗法,它引入了一个新时代,在这个时代,被诊断为早期肺癌的人可能有机会接受免疫疗法,以增加治愈的机会。”“今天具有里程碑意义的批准为医生和患者提供了一种治疗早期肺癌的新方法,这种方法有可能显著降低癌症复发的风险,此前十多年来,这种情况下的治疗进展有限。” “太多早期肺癌患者在手术后会出现疾病复发。现在,手术和化疗后免疫治疗的可用性为许多患者提供了新的希望和一个强大的新工具,以降低他们癌症复发的风险,“GO2肺癌基金会的联合创始人兼主席邦妮·阿达里奥说。“有了这一批准,早期筛查肺癌并在诊断时检测PD-L1比以往任何时候都更加重要,以帮助将这一进步带给能够受益的人。” 该批准是基于III期IMpower010研究的中期分析结果,该研究表明,与最佳支持性护理(BSC)相比,在手术和铂类化疗后使用Tecentriq治疗将肿瘤表达PD-L1≥1%的II-IIIA期(UICC/AJCC第七版)NSCLC患者的疾病复发或死亡风险降低了34%(危险比[HR]=0.66,95%CI:0.50-0.88)。Tecentriq的安全数据与其已知的安全概况一致,没有发现新的安全信号。在接受Tecentriq的患者中,致命和严重不良反应分别发生在1.8%和18%。最常见的严重不良反应(>1%)为肺炎(1.8%)、肺炎(1.6%)和发热(1.2%)。 该申请的审查是在FDA的Orbis项目倡议下进行的,该项目为国际合作伙伴之间同时提交和审查肿瘤药物提供了一个框架。根据美国食品和药物管理局的说法,国际监管机构之间的合作可能会让癌症患者在其他国家获得更早的产品,而这些国家的监管提交可能会出现严重延误。根据ORBIS项目,同时向美国、瑞士、联合王国、加拿大、巴西和澳大利亚的监管机构提交了申请。此外,FDA在其实时肿瘤学审查试点计划下审查并批准了补充申请,该计划旨在探索更有效的审查过程,以确保患者尽早获得安全有效的治疗。 Tecentriq以前在各种类型的肺癌中显示出有临床意义的益处,目前在美国有六个批准的适应症。除了成为第一个批准用于辅助NSCLC的癌症免疫疗法之外,Tecentriq也是第一个批准用于联合卡铂和足叶乙甙(化疗)一线治疗成人广泛期小细胞肺癌(SCLC)的癌症免疫疗法。Tecentriq在晚期非小细胞肺癌中也有四个批准的适应症,无论是单一药物还是与靶向治疗和/或化疗联合使用。Tecentriq有三种给药选择,提供了每两周、三周或四周选择给药的灵活性。 基因泰克对Tecentriq有一个广泛的开发项目,包括针对不同肺癌、泌尿生殖道癌、皮肤癌、乳腺癌、胃肠道癌、妇科癌、头颈部癌的多项正在进行和计划进行的三期研究。这包括单独评估Tecentriq和与其他药物联合应用的研究,以及在各种肿瘤类型的转移性、佐剂和新佐剂环境中的研究。 关于IMpower010研究 IMpower010是一项III期、全球、多中心、开放标签、随机研究,评估Tecentriq与BSC在IB-IIIA期NSCLC(UICC/AJCC第七版)参与者中的有效性和安全性,在手术切除和最多4个周期的辅助顺铂化疗后。这项研究以1:1的比例随机抽取了1005人,要么接受Tecentriq,为期1年(16个周期),除非疾病复发或出现不可接受的毒性,要么接受BSC。主要终点是PD-L1阳性II-IIIA期、所有随机化II-IIIA期和意图治疗(ITT)IB-IIIA期人群中研究者确定的DFS。关键的次要终点包括在整个研究人群中的总生存率(OS),即ITT IB-IIIA期NSCLC。 关于肺癌 美国癌症协会表示,预计2021年将有超过23.5万名美国人确诊患有肺癌。非小细胞肺癌占所有肺癌的80-85%,约50%的非小细胞肺癌患者被诊断为早期(I期和II期)或局部晚期(III期)疾病。今天,大约一半的早期肺癌患者在手术后仍然经历癌症复发。早期治疗肺癌,在它扩散之前,可能有助于防止疾病复发,并为人们提供最佳的治愈机会。 关于Tecentriq®(atezolizumab) Tecentriq是一种单克隆抗体,旨在与一种称为PD-L1的蛋白质结合。Tecentriq被设计用于与肿瘤细胞和肿瘤浸润免疫细胞上表达的PD-L1结合,阻断其与PD-1和B7.1受体的相互作用。通过抑制PD-L1,Tecentriq可能使T细胞重新激活。Tecentriq也可能影响正常细胞。 Tecentriq美国适应症 Tecentriq是一种处方药,用于治疗成人下列疾病: 一种叫做非小细胞肺癌(NSCLC)的肺癌。 TECENTRIQ可以单独用于肺癌的治疗: 以帮助防止他们的肺癌复发后,他们的肿瘤已被手术切除,并接受了以铂为基础的化疗,以及 他们有2到3A阶段的非小细胞肺癌(患者应该和他们的医疗保健提供者谈谈这些阶段的含义),以及 他们的“PD-L1”癌症检测呈阳性。 以帮助防止他们的肺癌复发后,他们的肿瘤已被手术切除,并接受了以铂为基础的化疗,以及 他们有2到3A阶段的非小细胞肺癌(患者应该和他们的医疗保健提供者谈谈这些阶段的含义),以及 他们的“PD-L1”癌症检测呈阳性。 当他们的肺癌: 已经蔓延或增长,而且 他们的“高PD-L1”癌症检测呈阳性,以及 他们的肿瘤没有异常的“EGFR”或“ALK”基因 已经蔓延或增长,而且 他们的“高PD-L1”癌症检测呈阳性,以及 他们的肿瘤没有异常的“EGFR”或“ALK”基因 Tecentriq可与贝伐单抗、紫杉醇和卡铂一起作为肺癌的首选治疗: 已经蔓延或增长,而且 是一种叫做“非鳞状非小细胞肺癌”的类型 他们的肿瘤没有异常的“EGFR”或“ALK”基因 已经蔓延或增长,而且 是一种叫做“非鳞状非小细胞肺癌”的类型 他们的肿瘤没有异常的“EGFR”或“ALK”基因 Tecentriq可与紫杉醇蛋白结合剂和卡铂一起作为肺癌的首选治疗药物: 已经蔓延或增长,而且 是一种叫做“非鳞状非小细胞肺癌”的类型 他们的肿瘤没有异常的“EGFR”或“ALK”基因 已经蔓延或增长,而且 是一种叫做“非鳞状非小细胞肺癌”的类型 他们的肿瘤没有异常的“EGFR”或“ALK”基因 当他们的肺癌: 已经蔓延或增长,而且 他们曾尝试过含有铂的化疗,但不起作用或不再起作用 如果他们的肿瘤有异常的“EGFR”或“ALK”基因,他们也应该尝试FDA批准的治疗这些异常基因的肿瘤的疗法,但它不起作用或不再起作用 已经蔓延或增长,而且 他们曾尝试过含有铂的化疗,但不起作用或不再起作用 如果他们的肿瘤有异常的“EGFR”或“ALK”基因,他们也应该尝试FDA批准的治疗这些异常基因的肿瘤的疗法,但它不起作用或不再起作用 一种叫做小细胞肺癌(SCLC)的肺癌。 Tecentriq可与化疗药物卡铂和足叶乙甙一起作为肺癌的首选治疗: 是一种被称为“广泛期小细胞肺癌”的类型,这意味着它已经扩散或生长 是一种被称为“广泛期小细胞肺癌”的类型,这意味着它已经扩散或生长 目前还不知道Tecentriq对儿童是否安全有效。 重要安全信息 关于Tecentriq最重要的信息是什么? Tecentriq可以导致免疫系统攻击身体任何区域的正常器官和组织,并影响它们的工作方式。这些问题有时会变得严重或危及生命,并可能导致死亡。病人可以同时有以上的这些问题之一。这些问题可能发生在治疗期间的任何时候,甚至在治疗结束后。 如果患者出现任何新的或更糟糕的体征或症状,应立即打电话或见他们的医疗保健提供者,包括: 肺部问题 咳嗽 呼吸急促 胸痛 肠道问题 腹泻(稀便)或大便比平时频繁 黑色、柏油状、粘稠或有血或粘液的大便 严重的胃部(腹部)疼痛或压痛 肝脏问题 皮肤发黄或眼白 严重恶心或呕吐 他们的胃区(腹部)右侧疼痛 深色尿(茶色) 比正常情况下更容易出血或瘀伤 激素腺体问题 不会消失的头痛或不寻常的头痛 眼睛对光的敏感度 眼睛问题 快速心跳 出汗增多 极度疲劳 体重增加或减轻 感觉比平时更饿或更渴 小便比平时多 脱发 感到寒冷 便秘 他们的声音变得更深了 头晕或昏厥 情绪或行为的改变,如性欲减退、易怒或健忘 肾脏问题 尿量减少 他们尿中带血 他们的脚踝肿胀 食欲不振 皮肤问题 皮疹 瘙痒 皮肤起泡或脱皮 口腔、鼻子、喉咙或生殖器部位疼痛的疮或溃疡 发烧或流感样症状 肿胀淋巴结 问题也可能发生在其他器官。 这些并不是Tecentriq可能发生的免疫系统问题的所有迹象和症状。如果出现任何新的或更糟糕的体征或症状,患者应该立即打电话或去看他们的医疗保健提供者,包括: 胸痛,心跳不规则,呼吸急促,或脚踝肿胀 困惑、嗜睡、记忆问题、情绪或行为改变、颈部僵硬、平衡问题、手臂或腿刺痛或麻木 重影,视力模糊,对光敏感,眼睛疼痛,视力改变 持续或严重的肌肉疼痛或无力,肌肉抽筋 红细胞低,瘀伤 输液反应有时会严重或危及生命。输液反应的体征和症状可能包括: 寒战或颤抖 瘙痒或皮疹 冲洗 呼吸急促或喘息 头晕 想昏过去 发热 背部或颈部疼痛 并发症,包括移植物抗宿主病(GVHD),在接受骨髓(干细胞)移植的人使用供体干细胞(异基因)。这些并发症可能很严重,并可能导致死亡。如果患者在接受Tecentriq治疗之前或之后接受移植,这些并发症可能会发生。医疗保健提供者将监测这些并发症。 立即就医可能有助于防止这些问题变得更加严重。医疗保健提供者将在患者使用Tecentriq治疗期间检查这些问题。医疗保健提供者可以用皮质类固醇或激素替代药物治疗病人。如果患者有严重的副作用,医疗保健提供者也可能需要推迟或完全停止Tecentriq的治疗。 在接受Tecentriq之前,患者应该告诉他们的医疗保健提供者他们的所有医疗状况,包括如果他们: 有免疫系统问题,如克罗恩病、溃疡性结肠炎或狼疮 接受了器官移植 已经接受或计划接受使用供体干细胞(异基因)的干细胞移植 已接受胸部放射治疗 患有影响神经系统的疾病,如重症肌无力或格林-巴利综合征 正在怀孕或计划怀孕。Tecentriq会伤害未出生的婴儿。如果患者在Tecentriq治疗期间怀孕或认为可能怀孕,应立即告诉他们的医疗保健提供者。能够怀孕的女性: 医疗保健提供者在开始使用Tecentriq治疗之前应该做妊娠测试 他们应该在治疗期间和最后一剂Tecentriq后至少5个月内使用有效的节育方法 医疗保健提供者在开始使用Tecentriq治疗之前应该做妊娠测试 他们应该在治疗期间和最后一剂Tecentriq后至少5个月内使用有效的节育方法 正在哺乳或计划哺乳。目前还不知道Tecentriq是否会进入母乳。患者在治疗期间和最后一剂Tecentriq后至少5个月内不应母乳喂养 病人应该告诉他们的医疗保健提供者他们服用的所有药物,包括处方药和非处方药,维生素和草药补充剂。 单独使用Tecentriq最常见的副作用包括: 感觉疲倦或虚弱 食欲减退 恶心 咳嗽 呼吸急促 Tecentriq与其他抗癌药物一起用于肺癌时最常见的副作用包括: 感觉疲倦或虚弱 恶心 脱发 便秘 腹泻 食欲减退 Tecentriq可能会导致女性的生育问题,这可能会影响生育能力。如果病人对生育有顾虑,他们应该和他们的医疗保健提供者谈谈。 这些并不是Tecentriq可能的全部副作用。患者应该向他们的医疗保健提供者或药剂师询问更多关于Tecentriq的好处和副作用的信息。 向FDA报告副作用,请拨打1-800-FDA-1088或http://www.FDA.gov/medwatch。 向基因泰克报告副作用,电话1-888-835-2555。 请参阅http://www.tecentriq.com了解完整的处方信息和其他重要的安全信息。 基因泰克在癌症免疫治疗中的应用 35年来,基因泰克一直在开发药物来重新定义肿瘤治疗,今天,实现癌症免疫治疗的全部潜力是一个主要的焦点领域。随着20多个免疫治疗分子的开发,基因泰克正在研究单独免疫治疗的潜在好处,以及与各种化疗、靶向治疗和其他免疫治疗相结合的潜在好处,目标是为每个人提供适合自己独特免疫系统的治疗。 除了基因泰克已批准的PD-L1检查点抑制剂,该公司广泛的癌症免疫治疗管道还包括其他检查点抑制剂、个体化新抗原疗法和T细胞双特异性抗体。欲了解更多信息,请访问http://www.gene.com/cancer-免疫疗法。 基因泰克在肺癌中的作用 肺癌是基因泰克关注和投资的主要领域,我们致力于开发新的方法、药物和测试,以帮助患有这种致命疾病的人。我们的目标是为每一个被诊断为肺癌的人提供有效的治疗选择。我们目前有五种已批准的药物治疗某些种类的肺癌,并正在开发10多种药物,以针对肺癌最常见的基因驱动因素或增强免疫系统以对抗这种疾病。 关于基因泰克 基因泰克成立于40多年前,是一家领先的生物技术公司,发现、开发、制造和商业化药物,以治疗严重和危及生命的疾病患者。该公司是罗氏集团的成员,总部设在加利福尼亚州的南旧金山。欲了解本公司的更多信息,请访问http://www.gene.com。 在businesswire.com查看源代码版本:https://www.businesswire.com/news/home/20211015005506/en/ 媒体联系: 伊丽莎白·休斯(650)467-6800 宣传联系: 大卫冷却(202)713-0083 投资者联系人: 罗兰·卡尔姆(650)467-8737 卡尔·马勒011 41 61 687 850 3 来源:基因泰克 在网上查看此新闻稿: http://www.businesswire.com/news/home/20211015005506/en

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