Atezolizumab/Hyaluronidase-tqjs

点击蓝字 关注我们 一、行业快讯 10月2日：艾博生物与诺华达成RNA疗法授权与选择权协议，授予诺华mRNA编码CD19×CD3 T细胞衔接器（TCE）ABO2203的全球独家许可，并附带基于艾博RNA平台开发后续管线的独家选择权；艾博将获得5.75亿美元首付款，全部选择权行使并达成开发、注册与商业化里程碑后潜在总额约72亿美元，交易总价值约77.75亿美元，刷新国内mRNA企业对外授权纪录。该交易标的是“分子＋平台期权”组合，说明跨国药企对中国平台型资产的定价重心已从单品转向持续产出能力。 10月7日：亚虹医药与专注女性健康的专科药企Theramex签署有条件《独家授权许可协议》，将光动力疗法产品APL-1702（希维她®/CEVIRA®）在欧洲国家及澳大利亚、新西兰、土耳其的独家权益授予对方，亚虹保留大中华区及其他市场权益，获得1,500万美元首付款、1,100万美元近期注册里程碑付款及商业化里程碑与分级销售提成，交易总额超2.5亿美元。该交易属“借船出海”的务实路径，以区域权益换取规范市场的注册与商业化能力。 10月8日：恒瑞医药PARP抑制剂氟唑帕利胶囊上市许可申请获欧洲药品管理局（EMA）受理，拟联合阿比特龙及糖皮质激素治疗部分转移性去势抵抗性前列腺癌，为恒瑞第二款直接向欧盟递交上市申请的自主创新药；与对外授权不同，自主申报欧洲上市对其国际注册与商业化能力提出更高要求。同期，众生药业控股子公司众生睿创的GLP-1/GIP双受体激动剂RAY1225注射液在超重及肥胖人群Ⅲ期临床达到主要终点，以两周一次给药形成相对主流周制剂的差异化。 10月8日至9日：邦耀生物基于通用型细胞平台（TyUCell）开发的靶向CD19基因修饰异体CAR-T产品BRL-303（TyU19）双线推进——复发/难治性系统性硬化症适应症于9月10日获CDE临床试验默示许可，10月8日正式纳入CDE“关爱计划—延伸”试点，成为中国首个纳入该试点的CAR-T类产品，标志异体通用型细胞治疗在自免领域由“一人一药”向平台化多适应症开发延伸。 10月8日至15日：FDA审批端连续落子——10月8日批准罗氏阿替利珠单抗（Tecentriq）及其皮下制剂Tecentriq Hybreza联合氟尿嘧啶与奥沙利铂，用于Ⅲ期错配修复缺陷（dMMR）结肠癌术后辅助治疗，基于ATOMIC研究使复发或死亡风险降低50%，为Tecentriq第12个美国适应症，也是该人群首个免疫辅助治疗方案；10月15日批准基因泰克Enspryng（satralizumab）用于甲状腺眼病，成为首个可居家皮下自注射的TED疗法，给药模式由输注中心转向患者自管。 10月9日：《关于发展新质生产力的意见》印发，将生物医药列为战略性新兴产业、生物制造纳入未来产业，产业定位由“新兴支柱”进一步向“战略新兴”抬升；同期《中国禁止出口限制出口技术目录》修订征求意见，凸显对生物医药核心技术自主可控与全球输出的双重政策取向。叠加9月已收官的2026年国家医保谈判与商保创新药目录价格协商（124个目录外药品完成基本医保谈判、12个创新药进入商保目录协商），支付端“基本医保＋商保”双轨衔接机制进入落地阶段。 10月5日至11日：临床与研发端数据密集读出——10月5日Vaxcyte公布31价肺炎球菌结合疫苗VAX-31关键Ⅲ期达到主要免疫原性及安全性终点，与辉瑞20价疫苗在20个共同血清型均达非劣效；10月11日百利天恒EGFR×HER3双抗ADC伦康依隆妥单抗（BL-B01D1）获国家药监局临床试验批准，可开展联合放疗治疗局部晚期不可切除头颈鳞癌等实体瘤研究。随着ESMO 2026年会临近，国产双抗、ADC与新机制资产的全球数据读出进入密集窗口。 二、专利数据概况 （一）总体情况 截至2026年10月15日，以IPC分类号A61K38（含肽类活性成分的医药配制品）与A61K39（含抗原或抗体的医药配制品）为统计口径，生物医药领域关于生物制药相关技术累计公开专利约208.16万件（2,081,556件）。2026年10月1日至15日新增公开专利1,154件，约占累计量的0.06%；按同一检索口径回溯，9月16日至30日为1,337件、9月1日至15日为1,592件，本期环比下降13.7%，较9月上半月回落27.5%，近三期半月新增量呈连续下行走势。需要说明的是，半月窗口末段公开数据存在回填滞后，本期实际值后续仍有小幅上修空间；同时10月上半月包含国庆假期，公开日分布相对集中，也构成短期读数偏低的技术性因素。 （二）专利权人排名（累计公开量TOP3） 申请人方面，生物制药相关技术累计公开量排名前三的专利权人为：罗氏／基因泰克（Roche/Genentech，56,222件）、辉瑞（Pfizer，37,839件）、葛兰素史克（GSK，35,516件），三者构成第一梯队。其后依次为赛诺菲（Sanofi，31,620件）、诺华（Novartis，28,105件）、默克／默沙东（Merck，27,422件）、安进（Amgen，18,977件）、武田（Takeda，16,985件）。从结构看，TOP3合计约12.96万件，占累计公开量的6.2%，头部集中度低于化学制药领域，反映生物制药技术路线分散、创新主体更为多元的特征；罗氏依托基因泰克在抗体与融合蛋白方向的长期积累领先优势明显，较第二名高出约49%。中国企业在该口径下尚未进入前十，单家累计量多在数千件量级，与跨国巨头仍存在数量级差距。 （三）2026年10月1—15日新增公开专利 2026年10月1日至15日期间，生物制药领域新增公开专利1,154件。新增公开量排名前三的专利权人为：罗氏／基因泰克（Roche/Genentech，15件）、杨森／强生（Janssen/Johnson & Johnson，7件）、诺华（Novartis，6件）。其后依次为默克／默沙东（5件）、安进（5件）、赛诺菲（5件）、武田（5件），四家并列第四；诺和诺德（4件）紧随其后，辉瑞与艾伯维各2件。本期头部新增量整体处于个位数区间，与窗口内新增总量回落相互印证，说明半月内单一主体的公开节奏波动较大，排名参考意义弱于累计口径。方向上，新增布局集中于抗体偶联、双抗／多抗、GLP-1类多肽与核酸递送四条主线，与同期产业端的授权交易热点高度重合。 注：本期专利数据经Patentics全球专利库（db/all）检索统计，与往期简报所用智慧芽全球库口径存在差异（累计总量偏差约2.7%），专利权人排名按该库申请人标准化口径合并统计，含子公司及多语种主体；跨期环比均在Patentics同口径内计算，不建议与往期简报的绝对数值直接比较。 三、总结及展望 （一）专利趋势分析 从专利数据看，生物制药领域呈现“存量高集中、增量低波动”的双重特征。累计口径上，罗氏／基因泰克以56,222件稳居首位，辉瑞（37,839件）、葛兰素史克（35,516件）分列二三位，TOP3合计约12.96万件，占累计公开量6.2%，头部企业的护城河主要建立在抗体工程、融合蛋白与递送平台的长期专利积累之上。增量口径上，本期新增1,154件，连续三期回落（1,592→1,337→1,154，累计降幅27.5%），除假期与回填滞后的技术性因素外，也反映生物制药专利公开进入阶段性平台期，行业投入更多转向临床后期资产的权益交易而非新增申请扩张。罗氏／基因泰克以15件继续领跑新增榜，杨森／强生（7件）、诺华（6件）紧随，MNC在自免、肿瘤与代谢三大方向仍是主要产出方；国内主体新增量分散在个位数区间，尚未形成稳定的头部集群。 （二）产业动态分析 从产业动态看，2026年10月上半月生物制药呈现三条主线。第一条主线是出海交易由“卖分子”转向“卖平台”：艾博生物与诺华77.75亿美元的交易将mRNA-TCE分子与RNA平台期权打包定价，亚虹医药以APL-1702区域权益换取欧洲商业化能力，两类交易分别对应平台型与区域型两种出海范式。据公开统计，2026年上半年中国创新药对外授权已达103笔、总额约1,001亿美元，其中过半资产在授权时仍处临床前及Ⅰ期阶段，早期差异化分子与技术平台的议价能力显著提升。第二条主线是监管与审批的双向突破：邦耀生物异体通用型CAR-T纳入CDE“关爱计划—延伸”试点，为源头创新罕见病药物开辟“提前介入、一企一策”的快车道；FDA先后批准罗氏Tecentriq的Ⅲ期dMMR结肠癌辅助治疗适应症与基因泰克的Enspryng甲状腺眼病居家自注射方案，前者拓展免疫治疗的辅助治疗边界，后者重塑给药场景。第三条主线是政策定位再抬升：《关于发展新质生产力的意见》将生物医药列为战略性新兴产业、生物制造纳入未来产业，与医保谈判“预申报”机制、商保创新药目录衔接共同构成“研发—准入—支付”的完整闭环。 （三）展望 综合专利数据与产业动态，生物制药领域短期内将呈现以下趋势：第一，平台型资产将继续成为跨境授权的主要标的，mRNA、双抗／多抗、ADC与通用型细胞治疗四条技术路线的专利布局与授权密度将同步上升，罗氏／基因泰克、辉瑞、葛兰素史克等头部主体的存量优势短期内难以撼动；第二，国内企业正从“专利数量追赶”转向“临床价值兑现”，恒瑞自主申报欧盟上市、邦耀纳入CDE试点、百利天恒双抗ADC进入联合治疗探索，均指向以注册能力和临床数据而非申请量参与全球竞争；第三，支付端双轨机制落地将缩短创新药从获批到放量的周期，反向激励企业在早期阶段加大核心专利布局，生物制药新增公开量有望在四季度回升。需关注的风险点包括：半月窗口公开数据的回填波动、跨境授权交易受海外审评与关税政策扰动、以及抗体与多肽核心靶点上MNC专利围栏对后来者的挤出效应。 END 【往期回顾】 高智量发布知识产权公共服务成果 10.21 | 粤深政策早知道 高智量发布深圳中小企业海外知识产权维权成本效益分析与援助模式创新研究项目成果 人工智能领域关于智能机器人专利与产业动态分析简报（2026年9月 第5期） 人工智能领域关于云计算专利与产业动态分析简报（2026年9月 第6期） 10.12 | 粤深政策早知道 生物医药领域关于合成生物学与生物制造专利与产业动态分析简报（2026年9月 第6期） 人工智能领域关于自动驾驶专利与产业动态分析简报（2026年9月 第4期） 华盛顿大学官方认证｜企业家全球战略合作研修营限额招募 2025 年度专利密集型产品认定公示！深圳企业可提前布局，有望享受专项资助红利 10.1国庆节｜与国同梦，共庆华诞 亚太同月，家国共圆｜高智量中秋国庆主题活动圆满举行 生物医药领域关于合成生物学与生物制造专利与产业动态分析简报（2026年9月 第1期） 高智量助力低空经济！广东“双五星”专利转化与产业精准对接会成功举办 近期知产三动态：AI侵权归责、差评引流出界、香港IP布局 9.20 | 粤深政策早知道 生物医药领域关于化学制药专利与产业动态分析简报（2026年8月 第5期） 9.14| 粤深政策早知道 "融通产业资源 共筑产城生态"企业家系列活动第一期走进高智量 2026年服贸会今天开幕 高智量知识产权线下参展 9.8 | 粤深政策早知道 中小企业出海知识产权赋能对接活动在佛山举办，李飞董事长作为WIPO 特聘专家现场问诊 高智量受邀出席2026年粤港知识产权与中小企业发展（佛山）讲座并专题演讲 深圳高智量知识产权运营有限公司，成立于2020年4月，旗下设有深圳高智量知识产权代理有限公司（机构代码为44851）、深圳高智量数据科技有限公司、前海国际知识产权综合运营服务中心、前海国际知识产权综合运营服务中心香港有限公司，是知识产权服务全链条、全牌照公司。 公司秉承“坚持一流标准、坚定价值创造、坚守服务品质”的发展理念，聚焦科技创新和商业市场，布局大湾区，深耕知识产权全球化服务，并与深港两地多所知名院校建立深度合作，聘请了一批在科技、产业、法律领域的资深专家担任高级顾问，培养了一批在知识产权战略咨询、运营转化、确权维权方面经验丰富的专业人才，为各类创新主体提供高质量的知识产权综合解决方案。 网址：http://www.aipbox.com 电话：0755-22670520   邮箱：hr@aipbox.com 地址： 深圳：深圳市前海深港合作区南山街道深商街51号中英人寿大厦1902          深圳市光明区新湖街道圳美大道501号B1栋515 香港：香港尖沙咀梳士巴利道3號星光行12樓14室 梅州：梅州市梅江区梅江控股13楼1301

Phase III Krascendo 1 results demonstrated divarasib’s superiority over current standard of care, first-generation KRAS G12C inhibitors, in previously treated advanced G12C-mutated non-small cell lung cancer Patient-reported outcomes from Phase III lidERA study showed improved efficacy of giredestrant over standard endocrine therapy is achieved without compromising tolerability and health-related quality of life in early-stage breast cancer Second Phase III results in Chinese patients with metastatic nasopharyngeal carcinoma demonstrate the potential of Tam-Peli, a next-generation B7-H3 targeted ADC, to deliver robust efficacy with a favorable safety pro high-unmet-need solid tumors SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- $RHHBY --Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), will present new data, including two late-breaking abstracts, across lung, breast and other cancers at the 2026 European Society for Medical Oncology (ESMO) Annual Meeting, held from October 23 to 27 in Madrid. “Our presentations at ESMO 2026 highlight the depth and impact of Genentech’s oncology pipeline, driven by emerging science capable of bringing new treatment benefits across diverse and high-unmet-need cancers,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “From establishing head-to-head superiority with divarasib in KRAS G12C-mutated lung cancer to advancing patient-centered oral SERD therapies like giredestrant and next-generation ADCs such as Tam-Peli, we are committed to delivering medicines that not only extend life, but also seek to improve treatment experience, tolerability and quality of life for people living with cancer.” Divarasib demonstrated superior efficacy and best-in-class potential in KRAS G12C NSCLC Genentech will share Phase III Krascendo 1 results, which demonstrated divarasib’s best-in-class efficacy, advancing the standard of care in previously treated KRAS G12C-mutated lung cancer. Krascendo 1 is the only global head-to-head trial to evaluate a next-generation KRAS G12C inhibitor versus approved first-generation inhibitors. Results for this potential best-in-class, next-generation KRAS G12C-targeted therapy will be presented as a late-breaking abstract during a Presidential Symposium. Giredestrant data support its potential to become the new standard of care in early-stage and advanced breast cancer Genentech will present new data highlighting the potential role of giredestrant, an investigational, oral, potent next-generation selective estrogen receptor degrader (SERD) and full antagonist, in estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer, a subtype in which more than 90% of cases are diagnosed at an early stage (I-III). Key presentations from early-stage to advanced disease include: Patient-reported outcomes from the Phase III lidERA Breast Cancer trial suggesting that the improved efficacy of giredestrant compared to endocrine therapy is achieved without compromising tolerability or Health-Related Quality of Life. Exploratory biomarker findings from the evERA Breast Cancer trial of giredestrant in combination with everolimus in ER-positive, HER2-negative advanced breast cancer in the post-cyclin-dependent kinase 4/6 inhibitor setting. Updated interim results for giredestrant plus inavolisib from the MORPHEUS Breast Cancer trial evaluating giredestrant treatment combinations in ER-positive, HER2-negative locally advanced or metastatic breast cancer. Data demonstrate the potential of a next generation B7-H3 targeted antibody-drug conjugate (ADC) Tam-Peli (tambotatug pelitecan) New data will also be presented for Tam-Peli, an investigational next-generation B7-H3-targeted ADC designed to deliver high-potency anti-tumor activity while limiting off-target toxicity. Tam-Peli is currently being investigated across multiple solid tumor indications: ESMO data include late-breaking interim Phase III results in heavily pretreated recurrent/metastatic nasopharyngeal carcinoma, analyses of interstitial lung disease in patients with advanced solid tumors from Phase I/II studies, and Phase I efficacy and safety data for Tam-Peli in patients with locally advanced or metastatic NSCLC. These findings build on the TAISHAN-302 Phase III data in second-line small cell lung cancer presented at the World Conference on Lung Cancer in September, where the study met all three specified endpoints of overall survival, progression free survival and objective response rate at its first interim analysis. Roche is developing and commercializing Tam-Peli outside mainland China, Hong Kong, and Macau, and plans to rapidly initiate global trials across multiple tumor types. Overview of key presentations featuring Genentech medicines and molecules: Medicine or molecule Abstract title Abstract number/ presentation details Lung cancer Divarasib Krascendo 1: Efficacy and safety of divarasib (diva) vs sotorasib (soto) or adagrasib (ada) in previously treated locally advanced or metastatic KRAS G12C-mutated NSCLC. #LBA5 Proffered Paper Session Presidential Symposium II Sunday 10.25.2026 16:30 - 16:42 CET Divarasib Krascendo 3: A randomized, Phase III trial in progress of divarasib vs immunotherapy or observation in patients with resected, stage II-IIIB, KRAS G12C+ non-small cell lung cancer. #2551 TiP Poster NSCLC, Early-Stage Monday 10.26.2026 12:00 – 12:45 CET Tam-Peli Tambotatug pelitecan (YL201): Efficacy and safety in locally advanced/ metastatic NSCLC from a Phase I study. #2577 Poster NSCLC, Locally Advanced Monday 10.26.2026 12:00 – 12:45 CET Non-specific Immunogenomic signature associated with ICI-related pneumonitis in non-small-cell lung cancer (NSCLC) patients. #4247 Rapid Oral Basic Science and Translational Research Sunday 10.25.2026 09:14 - 09:19 CET Breast cancer Giredestrant Patient (pt)-reported outcomes (PROs) from the Phase III lidERA Breast Cancer (BC) trial of giredestrant (GIRE) in pts with estrogen receptor-positive, HER2-negative early BC (ER+, HER2− eBC). #538 Rapid Oral Breast Cancer, Early-Stage Friday 10.23.2026 16:20 – 16:25 CEST Giredestrant Retrospective exploratory biomarker (BM) analyses from evERA Breast Cancer (BC): A Phase III trial of giredestrant (GIRE) + everolimus (E) in patients with estrogen receptor-positive, HER2-negative advanced BC (ER+, HER2− aBC) in the post-CDK4/6 inhibitor (I) setting. #2 Rapid Oral Breast Cancer, Advanced Stage Saturday 10.24.2026 10:20 – 10:25 CEST Giredestrant Updated interim analysis of giredestrant (GIRE) + inavolisib (INAVO) in MORPHEUS Breast Cancer (BC): A Phase Ib/II study of GIRE treatment (tx) combinations in patients (pts) with estrogen receptor-positive, HER2-negative locally advanced/metastatic BC (ER+, HER2− LA/mBC). #23 Poster Advanced Breast Cancer, Other Saturday 10.24.2026 12:00 – 12:45 CEST Pertuzumab Real-world eligibility for DESTINY-Breast11 (DB-11) neoadjuvant escalation criteria and outcomes of DB-11-eligible vs DB-11-ineligible patients with HER2-positive early breast cancer (HER2+ eBC). #594 Poster Breast Cancer, Early-Stage Saturday 10.24.2026 12:00 – 12:45 CEST ZN-1041 BREnnA: Phase II/III randomized study of ZN-A-1041 or tucatinib (TUC), in combination with trastuzumab + capecitabine (HX), in patients with HER2-positive locally advanced or metastatic breast cancer (HER2+LA/mBC) with or without central nervous system (CNS) metastases. #1796 TiP Poster HER2+ Breast Cancer Saturday 10.24.2026 12:00 – 12:45 CEST Solid tumors Tam-Peli Tambotatug pelitecan (YL201): Analyses of interstitial lung disease in patients with advanced solid tumors from Phase I/II studies. #1057 Poster Developmental Therapeutics Friday 10.23.2026 15:15 – 16:00 CEST YL211 (cMET ADC) Phase I First-in-Human (FIH) Results of YL211, a c-Met targeting Antibody-Drug Conjugate (ADC), in patients (pts) with advanced solid tumors. #1017 Poster Developmental Therapeutics Friday 10.23.2026 15:15 – 16:00 CEST Tam-Peli Tam-Peli versus chemotherapy in heavily pretreated recurrent/metastatic nasopharyngeal carcinoma (R/M NPC): a multicenter, randomized, open-label, Phase III study (TAISHAN-301). #LBA43 Proffered Paper Session Head and Neck Cancer Sunday 10.25.2026 08:40 - 08:50 CET Tecentriq (atezolizumab) + Avastin (bevacizumab) Outcomes by baseline tumor burden using 6-and-12 scores and the up-to-7 criteria in TALENTACE: Phase III study of on-demand transarterial chemoembolization (TACE) combined with atezolizumab + bevacizumab (Atezo/Bev) or on demand TACE alone in patients with systemically untreated, unresectable hepatocellular carcinoma (uHCC). #1700 ePoster Hepatocellular Carcinoma Tecentriq (atezolizumab) ATOMIC (A021502/AIO-KRK-0317): Presentation and outcomes in patients (pts) with stage III d-MMR early-onset colon cancer (EOCC) and average-onset colon cancer (AOCC). #858 Poster Colon Cancer Sunday 10.25.2026 12:00 - 12:45 CET Tecentriq (atezolizumab) Adjuvant atezolizumab in patients with MSI-high/MMR-deficient stage III colorectal cancer ineligible for oxaliplatin-based chemotherapy: the Phase II ANTONIO-study (AIO-KRK-0220). #802 Poster Colon Cancer Sunday 10.25.2026 12:00 - 12:45 CET What is Itovebi? Itovebi (inavolisib) is a prescription medicine used in combination with the medicines palbociclib and fulvestrant to treat adults who have hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has an abnormal phosphatidylinositol-3-kinase catalytic subunit alpha ( PIK3CA ) gene, and has spread to nearby tissue or lymph nodes (locally advanced), or to other parts of the body (metastatic), and has come back after hormone (endocrine) therapy. Your healthcare provider will test your cancer for abnormal PIK3CA genes to make sure that Itovebi is right for you. It is not known if Itovebi is safe and effective in children. Important Safety Information What are the possible side effects of Itovebi? Itovebi may cause serious side effects, including: High blood sugar levels (hyperglycemia). High blood sugar is common with Itovebi and may be severe. Your healthcare provider will monitor your blood sugar levels before you start and during treatment with Itovebi. Your blood sugar levels may be monitored more often if you have a history of Type 2 diabetes. Your healthcare provider may also ask you to self-monitor and report your blood sugar levels at home. This will be required more frequently in the first 4 weeks of treatment. If you are not sure how to test your blood sugar levels, talk to your healthcare provider. You should stay well-hydrated during treatment with Itovebi. Tell your healthcare provider right away if you develop symptoms of high blood sugar, including: difficulty breathing nausea and vomiting (lasting more than 2 hours) stomach pain excessive thirst dry mouth more frequent urination than usual or a higher amount of urine than normal blurred vision unusually increased appetite weight loss fruity-smelling breath flushed face and dry skin feeling unusually sleepy or tired confusion Mouth sores (stomatitis). Mouth sores are common with Itovebi and may be severe. Tell your healthcare provider if you develop any of the following in your mouth: pain swelling redness ulcers Diarrhea is common with Itovebi and may be severe. Severe diarrhea can lead to the loss of too much body water (dehydration) and kidney injury. Tell your healthcare provider right away if you develop diarrhea, stomach-area (abdominal) pain, or see mucus or blood in your stool during treatment with Itovebi. Your healthcare provider may tell you to drink more fluids or take medicines to treat your diarrhea. Your healthcare provider may tell you to decrease your dose, temporarily stop your treatment, or completely stop your treatment with Itovebi if you develop certain serious side effects. The most common side effects and abnormal blood test results of Itovebi when used in combination with palbociclib and fulvestrant include: decreased white blood cell counts, red blood cell counts, and platelet counts decreased blood levels of calcium, potassium, sodium, and magnesium increased creatinine blood levels tiredness increased blood levels of the liver enzyme alanine transaminase (ALT) nausea rash loss of appetite COVID-19 infection headache Itovebi may affect fertility in males and in females who are able to become pregnant. Talk to your healthcare provider if this is a concern for you. These are not all the possible side effects of Itovebi. Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or . You may also report side effects to Genentech at (877) 436-3683. Before you take Itovebi, tell your healthcare provider about all of your medical conditions, including if you: have a history of diabetes or high blood sugar have kidney problems are pregnant or plan to become pregnant. Itovebi can harm your unborn baby. Females who are able to become pregnant: Your healthcare provider will check to see if you are pregnant before you start treatment with Itovebi. You should use effective non-hormonal birth control (contraception) during treatment with Itovebi and for 1 week after your last dose. Talk to your healthcare provider about what birth control method is right for you during this time. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Itovebi. Males with female partners who are able to become pregnant: You should use effective birth control (contraception) during treatment with Itovebi and for 1 week after your last dose. are breastfeeding or plan to breastfeed. It is not known if Itovebi passes into your breastmilk. Do not breastfeed during treatment with Itovebi and for 1 week after your last dose. Talk to your healthcare provider about the best way to feed your baby during treatment with Itovebi. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Please see additional Important Safety Information in the full Itovebi Prescribing Information or visit . What are Tecentriq and Tecentriq Hybreza? Tecentriq (atezolizumab) and Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) are prescription medicines used to treat: Adults with a type of lung cancer called non-small cell lung cancer (NSCLC). Tecentriq or Tecentriq Hybreza may be used alone as a treatment for your lung cancer: to help prevent your lung cancer from coming back after your tumor(s) has been removed by surgery and you have received platinum-based chemotherapy, and you have stage 2 to stage 3A NSCLC (talk to your healthcare provider about what these stages mean), and your cancer tests positive for “PD-L1”. Tecentriq or Tecentriq Hybreza may be used alone as your first treatment when your lung cancer: has spread or grown, and your cancer tests positive for “high PD-L1”, and your tumor does not have an abnormal “EGFR” or “ALK” gene. Tecentriq or Tecentriq Hybreza may be used with the medicines bevacizumab, paclitaxel, and carboplatin as your first treatment when your lung cancer: has spread or grown, and is a type called “non-squamous NSCLC”, and your tumor does not have an abnormal “EGFR” or “ALK” gene. Tecentriq or Tecentriq Hybreza may be used with the medicines paclitaxel protein-bound and carboplatin as your first treatment when your lung cancer: has spread or grown, and is a type called “non-squamous NSCLC”, and your tumor does not have an abnormal “EGFR” or “ALK” gene. Tecentriq or Tecentriq Hybreza may be used alone when your lung cancer: has spread or grown, and you have tried chemotherapy that contains platinum, and it did not work or is no longer working. If your tumor has an abnormal “EGFR” or “ALK” gene, you should have also tried an FDA-approved therapy for tumors with these abnormal genes, and it did not work or is no longer working. Adults with a type of lung cancer called “extensive stage small cell lung cancer (SCLC)”, which is SCLC that has spread or grown Tecentriq or Tecentriq Hybreza may be used with the chemotherapy medicines carboplatin and etoposide as your first treatment Tecentriq or Tecentriq Hybreza may be used with the medicine lurbinectedin as maintenance treatment when your lung cancer: has not progressed after first treatment with Tecentriq or Tecentriq Hybreza and the chemotherapy medicines carboplatin and etoposide. Adults with a type of liver cancer called hepatocellular carcinoma (HCC). Tecentriq or Tecentriq Hybreza may be used with the medicine bevacizumab when your liver cancer: has spread or cannot be removed by surgery, and you have not received other medicines by mouth or injection through your vein (IV) to treat your cancer. Adults with a type of skin cancer called melanoma. Tecentriq or Tecentriq Hybreza may be used with the medicines cobimetinib and vemurafenib when your melanoma: has spread to other parts of the body or cannot be removed by surgery, and has a certain type of abnormal “BRAF” gene. Your healthcare provider will perform a test to make sure this Tecentriq or Tecentriq Hybreza combination is right for you. Adults and children (12 years of age and older), with a type of soft tissue tumor (cancer) called alveolar soft part sarcoma (ASPS). Tecentriq or Tecentriq Hybreza may be used when your sarcoma: has spread to other parts of the body or cannot be removed by surgery. Adults with a type of bladder cancer called muscle invasive bladder cancer (MIBC) that has spread into the muscle layer of the bladder but not to other parts of the body. Tecentriq or Tecentriq Hybreza may be used alone as a treatment for your bladder cancer: to help prevent your bladder cancer from coming back after your bladder has been removed by surgery, and small pieces of DNA from the tumor (called circulating tumor DNA [ctDNA]) were found in your blood, showing that cancer cells remain in the body (molecular residual disease). Your healthcare provider will perform a test to make sure that Tecentriq or Tecentriq Hybreza is right for you. Adults and children with a type of colon cancer (Tecentriq is for children 2 years of age and older; Tecentriq Hybreza is for children 12 years of age and older and who weigh 88 pounds (40kg) or more) . Tecentriq or Tecentriq Hybreza may be used with a fluoropyrimidine and oxaliplatin medicine: to help prevent your colon cancer from coming back after your tumor(s) have been removed by surgery, and you have stage 3 colon cancer, and your tumor has been shown by a laboratory test to be mismatch repair deficient (dMMR). It is not known if Tecentriq Hybreza is safe and effective when used: in children younger than 12 years of age for the treatment of ASPS or colon cancer. in children for the treatment of NSCLC, SCLC, HCC, melanoma or MIBC. It is not known if Tecentriq is safe and effective when used: in children younger than 2 years of age for the treatment of ASPS or colon cancer. in children for the treatment of NSCLC, SCLC, HCC, melanoma or MIBC. Important Safety Information Who should not receive Tecentriq Hybreza? Do not receive Tecentriq Hybreza if you are allergic to hyaluronidase or any of the ingredients in Tecentriq Hybreza. What is the most important information about Tecentriq and Tecentriq Hybreza? Tecentriq and Tecentriq Hybreza can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during your treatment or even after your treatment has ended. Call or see your healthcare provider right away if you develop any new or worsening 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 your skin or the whites of your eyes severe nausea or vomiting pain on the right side of your 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 your voice gets deeper dizziness or fainting changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness Kidney problems decrease in your amount of urine blood in your urine swelling of your ankles loss of appetite Skin problems rash itching skin blistering or peeling painful sores or ulcers in your mouth or your 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 or Tecentriq Hybreza. Call or see your healthcare provider right away for any new or worsening 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 Rejection of a transplanted organ or tissue. Your healthcare provider should tell you what signs and symptoms you should report and monitor you depending on the type of organ or tissue transplant that you have had. 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 you underwent transplantation either before or after being treated with Tecentriq or Tecentriq Hybreza. Your healthcare provider will monitor you for these complications. Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare provider will check you for these problems during your treatment with Tecentriq or Tecentriq Hybreza. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop treatment with Tecentriq or Tecentriq Hybreza if you have severe side effects. Before you receive Tecentriq or Tecentriq Hybreza, tell your healthcare provider about all of your medical conditions, including if you: have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus have received an organ or tissue transplant, including corneal transplant have received or plan to receive a st Contacts Media Contact: Stella Belonwu, (650) 467-6800 Advocacy Contact: Catherine Creme Henry, (202) 258-8828 Investor Contacts: Loren Kalm, (650) 225-3217 Bruno Eschli, +41 61 68-75284 Read full story here