Lutetium Dotatate LU-177

Ajovy (fremanezumab-vfrm) Emgality (galcanezumab-gnlm) Nurtec ODT (rimegepant) Ubrelvy (ubrogepant) Vyepti (eptinezumab-jjmr) Hypertension The "Warnings and Precautions", "Adverse Reactions", "Patient Counseling Information", and "Patient Information" sections of the labeling were updated in March 2025 to include information about the risk of hypertension. Example: Ajovy labeling Apriso (mesalamine) Asacol (mesalamine) Asacol HD (mesalamine) Azulfidine (sulfasalazine) Azulfidine EN-Tabs (sulfasalazine) Canasa (mesalamine) Colazal (balsalazide disodium) Delzicol (mesalamine) Dipentum (osalazine sodium) Giazo (balsalazide disodium) Lialda (mesalamine) Rowasa (mesalamine) Pentasa (mesalamine) Severe cutaneous adverse reactions The Warnings and Precautions section of the labeling was updated November 2021 to include severe cutaneous adverse reactions. Example: Delzicol labeling Avastin (bevacizumab) Mvasi (bevacizumab-awwb) Zirabev (bevacizumab-bvzr) Pancreatitis FDA determined that no action is necessary at the time based on available information. Avastin (bevacizumab) Mvasi (bevacizumab-awwb) Zirabev (bevacizumab-bvzr) Anaphylactic shock The "Warnings and Precautions" section of the labeling was updated between September 2022 and February 2023 to include anaphylactoid/anaphylactic reactions. Example: Avastin labeling Ayvakit (avapritinib) Photosensitivity reaction The "Warnings and Precautions", "Adverse Reactions", "Patient Counseling Information", and "Patient Information" sections of the labeling were updated in March 2023 to include information about photosensitivity. Ayvakit labeling Azacitidine Onureg (azacitidine) Vidaza (azacitidine) Generic products containing azacitidine Pericarditis The "Adverse Reactions" section of the labeling was updated between September 2022 and June 2023 to include pericarditis. Example: Vidaza labeling FDA determined that no action is necessary at the time based on available information for Onureg. Bavencio (avelumab) Imfinzi (durvalumab) Libtayo (cemiplimab-rwlc) Keytruda (pembrolizumab) Opdivo (nivolumab) Tecentriq (atezolizumab) Yervoy (ipilimumab) Tumour lysis syndrome FDA determined that no action is necessary at the time based on available information. Cymbalta (duloxetine hydrochloride) Drizalma Sprinkle (duloxetine hydrochloride) Generic products containing duloxetine hydrochloride Anosmia, Hyposmia This issue is posted as two individual newly identified safety signal (NISS) entries in the January-March 2022 quarter, to reflect the focus on the potential signals of anosmia and hyposmia, separately. Darzalex (daratumumab) Darzalex Faspro (daratumumab and hyaluronidase-fihj) Blood stem cell transplant failure FDA determined that no action is necessary at the time based on available information. Dipeptidyl peptidase-4 (DPP-4) inhibitors Glyxambi (empagliflozin and linagliptin) Janumet (metformin hydrochloride and sitagliptin phosphate) Janumet XR (metformin hydrochloride and sitagliptin phosphate) Jentadueto (linagliptin and metformin hydrochloride) Jentadueto XR (linagliptin and metformin hydrochloride) Kazano (alogliptin and metformin hydrochloride) Kombiglyze XR (metformin hydrochloride and saxagliptin) Nesina (alogliptin) Onglyza (saxagliptin) Oseni (alogliptin and pioglitazone) Steglujan (ertugliflozin and sitagliptin) Tradjenta (linagliptin) Trijardy XR (empagliflozin, linagliptin and metformin hydrochloride) Qtern (saxagliptin and dapagliflozin) Generic products containing dipeptidyl peptidase-4 inhibitors Tubulointerstitial nephritis The "Adverse Reactions" section of the labeling was updated between March 2022 and June 2022 for products containing alogliptin and sitagliptin to include tubulointerstitial nephritis. Example: Janumet labeling FDA determined that no action is necessary for products containing linagliptin and saxagliptin at the time based on available information. *An administrative error resulted in the omission of Januvia from the list of product names after the initial quarterly report was posted. Dupixent (dupilumab) Angioedema The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in December 2021 to include angioedema. Dupixent labeling Glucagon-like peptide-1 (GLP-1) analogues Adlyxin (lixisenatide) Bydureon (exenatide) Bydureon BCise (exenatide) Byetta (exenatide) Ozempic (semaglutide) Rybelsus (semaglutide) Saxenda (liraglutide) Soliqua 100/33 (insulin glargine and lixisenatide injection) Trulicity (dulaglutide) Victoza (liraglutide) Wegovy (semaglutide) Xultophy 100/3.6 (insulin degludec and liraglutide injection) Generic products containing glucagon-like peptide-1 analogues Gallbladder related disorders The "Warnings and Precautions", "Adverse Reactions", and "Patient Counseling Information" sections of the GLP-1 analogues labeling were updated between March 2022 and June 2022 to include information about acute gallbladder disease. Example: Adlyxin labeling FDA has determined that the last approved labeling for Saxenda and Wegovy is adequately labeled for acute gallbladder disease, and that no further regulatory action is needed at this time. Gonadotropin releasing hormone (GnRH) analogues Fensolvi (leuprolide acetate) Lupron Depot-PED (leuprolide acetate) Supprelin LA (histrelin acetate) Synarel (nafarelin acetate) Triptodur (triptorelin) Idiopathic intracranial hypertension The "Warnings", "Precautions", and "Adverse Reactions" sections of the labeling were updated in April 2022 to include idiopathic intracranial hypertension. Example: Fensolvi labeling Jakafi (ruxolitinib phosphate) Herpes simplex virus (HSV) reactivation and/or disseminated HSV The "Dosage and Administration", "Warnings and Precautions", and "Adverse Reactions" sections of the labeling were updated in January 2023 to include information about herpes simplex and herpes zoster infections. Jakafi labeling Ibrance (palbociclib) Kisqali (ribociclib) Kisqali Femara Co-Pack (letrozole and ribociclib) Embolic and thrombotic events, venous The "Adverse Reactions" section of the Ibrance labeling was updated in December 2024 to include venous thromboembolism. Ibrance labeling FDA determined that no action is necessary at the time for Kisqali and Kisqali Femara Co-Pack based on available information. Ocrevus (ocrelizumab) Myocardial infarction FDA determined that no action is necessary at the time based on available information. Potassium Chloride Product preparation error The “Warnings” section of the labeling was updated in December 2022 to include information about fatal cardiac adverse reactions with intravenous administration of undiluted potassium chloride. Praxbind (idarucizumab) Wrong dose errors The carton labeling and "Dosage and Administration" sections of the labeling were revised in February 2022 to clarify the number of vials included in each carton and the recommended dosing. Praxbind labeling Qbrexza (glycopyrronium tosylate) Accidental exposure to product The container label, carton labeling, "Dosage and Administration", "Warnings and Precautions", "Patient Counseling Information", and "Patient Information" sections of the labeling were updated in October 2022 to include information about accidental exposure. Qbrexza labeling Qbrexza (glycopyrronium tosylate) Urinary retention The “Warnings and Precautions”, “Adverse Reactions”, and “Patient Counseling Information” sections of the labeling were updated in October 2022 to include information about new or worsening urinary retention. Qbrexza labeling Sodium-glucose cotransporter-2 (SGLT-2) inhibitors Farxiga (dapagliflozin) Glyxambi (empagliflozin and linagliptin) Invokamet (canagliflozin and metformin hydrochloride) Invokamet XR (canagliflozin and metformin hydrochloride) Invokana (canagliflozin) Jardiance (empagliflozin) Qtern (saxagliptin and dapagliflozin) Steglatro (ertugliflozin) Steglujan (ertugliflozin and sitagliptin) Segluromet (ertugliflozin and metformin hydrochloride) Synjardy (empagliflozin and metformin hydrochloride) Synjardy XR (empagliflozin and metformin hydrochloride) Trijardy XR (empagliflozin, linagliptin and metformin hydrochloride) Xigduo XR (dapagliflozin and metformin) Generic products containing sodium-glucose cotransporter-2 (SGLT-2) inhibitors Tubulointerstitial nephritis FDA determined that no action is necessary at the time based on available information. Somatostatin Receptor Imaging Agents Detectnet (copper Cu-64 dotatate injection) Gallium Dotatoc (GA 68) Octreoscan (Indium In 111 Pentetreotide) Netspot (Gallium GA 68 Dotatate) Hypersensitivity The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in December 2021 to include hypersensitivity reactions. Example: Netspot labeling Stromectol (ivermectin) Generic products containing ivermectin Off label use FDA determined that no action is necessary at the time based on available information. Stromectol (ivermectin) Generic products containing ivermectin Neurotoxicity The "Warnings", "Adverse Reactions", and "Overdosage" sections of the labeling were updated in March 2022 to include neurotoxicity. Example: Stromectol labeling Sunosi (solriamfetol hydrochloride) Hypersensitivity FDA determined that no action is necessary at the time based on available information. Vivitrol (naltrexone) Incorrect route of product administration The container label (vial), carton labeling, "Dosage and Administration", "Warnings and Precautions", and "Description", sections of the labeling were revised in September 2022 to emphasize the appropriate route and site of administration. Vivitrol labeling Xcopri (cenobamate) Psychiatric disorders The "Adverse Reactions" section of the labeling was updated in June 2022 to include psychiatric disorders. Xcopri labeling Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

精准医疗时代，核药正在逐步成为新的抗癌武器。核药不仅能够做到精准诊断肿瘤，还能从内部摧毁瓦解癌细胞。全球制药巨头在纷纷布局的同时，中国创新药企也在奋力追赶。 1898年，居里夫人首次提取出放射性元素镭；1946年首次成功将放射性物质注射到人体内治疗肿瘤；1950年，雅培推出了首款商业放射性药物131I人体血清蛋白（RISA）；1970年，FDA宣布将逐步撤销对放射性药物的豁免，并开始将其作为药物进行监管。2018年，诺华的Lutathera上市，为RDC药物开发拉开了序幕。 （图片来源：Frost＆Sullivan《中国放射性药物产业现状与未来发展蓝皮书》） 反观中国放射性药物虽然起步晚，但是发展却异常迅速。20世纪50年代末到1965年，中国放射性药物产业开始萌芽；1966年到1983年，放射性药物生产规模开始逐步扩大，政策监管条例也不断完善，产业的格局开始呈现出完整趋势；1984年到现在，监管制度的进一步完善，市场准入壁垒的形成，放射性药物进入了成熟的发展阶段。 （图片来源：Frost＆Sullivan《中国放射性药物产业现状与未来发展蓝皮书》） 精准诊疗需求驱动 核药从一开始“谈核色变”走到爆发式前进并非是偶然，而是多方面因素共同作用的结果。 首先，核药在肿瘤诊疗中具备有不可替代的优势。放射性配体疗法（RLT）的原理就是与特异性分子结合的放射性核素，通过跟靶细胞表面高表达的生物标志物特异性靶向结合，定位到全身各处肿瘤病灶，利用辐射杀伤靶细。 其次，政策支持也是关键因素之一。2021年6月，国家原子能机构、科技部等8部门联合发布《医用同位素中长期发展规划（2021-2035年）》，这是我国首个针对核技术医疗卫生领域发布的纲领性文件。 并且，核药领域的技术壁垒较高。放射性配体疗法所需的核素、配体都有相应的门槛，核素生产依赖于大型核反应堆或回旋加速器，其建造和运作都有较高的技术门槛和异常严格的规定。 放射性核素偶联药物（RDC）正在朝着诊疗一体化方向发展，实现个体化的诊疗与治疗。随着放射性药物基础以及临床研究的应用转化，核医学诊疗一体化将在未来实现“全面开花”。 （图片来源：Frost＆Sullivan《中国放射性药物产业现状与未来发展蓝皮书》） MNC领衔狂奔 要说MNC在核药领域的布局，首先就不得不提到“先行军”诺华。2017年到2018年开始，诺华前后斥资近百亿美元在核药赛道上“买买买”：先后获得RDC治疗药物Lutathera®、Pluvicto®，并因此坐实了全球RDC领域的头把交椅。Pluvicto®于2022年获得FDA批准上市，诺华也因此在市场上取得了巨大的成功，掀起了RDC的热潮。 根据诺华的2025H1财报显示Lutathera®、Pluvicto®这两款产品分别营收8.25亿美元（+26%）和4.00亿美元（+16%），共计12.25亿美元，并且Pluvicto®是全球首款年营收突破10亿美元大关的产品。 除了诺华以外，较早布局核药领域的还有一位——拜耳。拜耳早在2009年就与Algeta合作开发了Xofigo®，并且在2013年获批上市。上市后Xofigo®的销售额在2017年达到峰值（4.08亿欧元），后面开始逐渐呈现下滑趋势。虽然如此，但是拜耳从未停止核药赛道狂奔的脚步。 Pluvicto®的成功无疑让MNC都开始躁动，BMS就是其中之一。2023年BMS以约250%的溢价收购了RayzeBio，后续又与Philochem AG达成协议，获得OncoACP3的全球权益。 阿斯利康也在2020与Fusion Pharmaceuticals达成合作，开发下一代基于α粒子的核药。通过合作阿斯利康看到了核药的更多的可能性，核药快速升温的时候，阿斯利康用最直接的方式，24亿美元收购Fusion，宣布自己正式闯入核药赛道。 除此之外，默克、赛诺菲、强生等头部MNC都在核药领域积极布局。 国内药企积极卡位 中国核药市场虽然起步晚，但已目前明显已经涌现出一批积极布局的企业。 远大医药是国内核药领域的龙头企业之一。 公司核药抗肿瘤诊疗板块2025年上半年收入录得约4.2亿港元，再次实现超100%的大幅增长。远大医药作为全球仅有的四家实现创新核药商业化的药企之一，已经率先步入收获期。 公司核心产品易甘泰®钇[90Y]微球注射液主要应用于肝癌的选择性内放射治疗（SIRT）。同时，远大医药已经构建了丰富的产品管线，在研发注册阶段共储备了15款创新产品，涵盖68Ga、177Lu、131I、90Y、89Zr在内的5种放射性核素，覆盖了肝癌、前列腺癌、肾癌、脑癌等在内的7个癌种。 同时东诚药业也是国内核药领域的重要参与者。2025年上半年，公司核药业务实现收入5.03亿元（同比+1%），其中18F-FDG实现收入2.12亿元（同比+9%）。 除了传统药企，一批新兴核药企业也先后成立并斩获较高融资，如智核生物、辐联医药、核欣医药、艾博兹医药、诺宇医药、晶核生物、核舟医药等。 百亿蓝海正在展开 预计到2030年，全球放射性药物市场规模将达到119.3亿美元，而我国放射性药物市场规模预计在2025年将超过127亿元。 核医学领域常用的99Mo、125I、131I等8种医用同位素，保守估计每年需求量将以5%-30%的速度增长，年平均增速25%，预计到2030年需求总量将增加10倍以上。 虽然目前国内绝大多数医用放射性核素仍依赖进口，但这一局面正在改变。远大医药在成都温江投资逾30亿元的全球首个“零辐射”智能核药工厂已取得甲级辐安证。 核药航道的竞争刚刚开始，核药产业正从“小众赛道”向千亿级市场推进。 转载自瞪羚社 免责声明 本文系转载，仅做分享之用，不代表平台观点。图片、文章、字体等版权均属于原作者所有，如有侵权请告知，我们会及时处理。