DEPECA-1 - DEfeating PEnile Cancer 1 - A Phase II Study to Evaluate a First-line Systemic Therapy With Enfortumab Vedotin Plus Avelumab for Advanced and Metastatic Penile Carcinoma

The DEPECA-1 trial is the first systematic Phase II trial to evaluate response and survival to a combination of antibody-drug conjugate enfortumab vedotin plus the PD-L1 inhibitor avelumab in patients with locally advanced and metastatic penile squamous cell carcinoma (PeCa) in the 1st line setting.

开始日期2025-10-01

申办/合作机构

Astellas Pharma GmbH

[+2]

NCT06939036

/ Recruiting临床1/2期

A Multicentre, Open-label, Phase I/II Study Investigating the Safety, Tolerability, and Preliminary Efficacy of 225Ac-SSO110 in Participants With Extensive Stage Small Cell Lung Cancer (ES-SCLC) or Merkel Cell Carcinoma (MCC) Receiving Standard of Care (SoC)

This study aims to determine safety, tolerability, recommended phase 2 dose (RP2D), and preliminary antitumor activity of 225Ac-SSO110 with standard of care (SoC) therapy in patients with somatostatin receptor 2 expressing (SSTR2+) extensive-stage small cell lung cancer (ES-SCLC) and recurrent locally advanced or metastatic Merkel cell carcinoma (MCC).

开始日期2025-07-01

申办/合作机构

Ariceum Therapeutics GmbH

NCT05687721

/ Withdrawn临床1/2期IIT

A Phase II Trial With Copanlisib Plus Avelumab as a Maintenance Therapy for Metastatic Bladder Cancer After Platinum-based Chemotherapy

Patients with metastatic bladder cancer are usually treated with chemotherapy. If their cancers do not progress after chemotherapy, they can be enrolled into this study and receive a standard-of-care immunotherapy medication named avelumab plus a study drug named copanlisib.

开始日期2025-06-02

申办/合作机构

VA Office of Research and Development

[+1]

100 项与阿维单抗相关的临床结果

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100 项与阿维单抗相关的转化医学

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100 项与阿维单抗相关的专利（医药）

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1,172

项与阿维单抗相关的文献（医药）

2025-12-31·OncoImmunology

Avelumab induces greater Fc-Fc receptor-dependent natural killer cell activation and dendritic cell crosstalk compared to durvalumab

Article

作者: Srivastava, Raghvendra M ; Makarov, Vladimir ; Rupani, Amit ; Chan, Timothy A ; Osborne, Nicole

Several FDA-approved anti-PD-L1 (programmed cell death ligand-1) monoclonal antibodies (mAbs) are used to treat cancer. While these mAbs primarily target and intercept PD-L1:PD-1 inhibitory signaling in T-cells, the Fc-domains of these mAbs are distinct, and the unique cellular cascades triggered by differing Fc-domains of PD-L1 mAbs have not been directly investigated. In this study, we compared the innate immune effects of two widely used anti-PD-L1 IgG1 mAbs which bear distinct Fc-domains, avelumab (native-Fc) and durvalumab (mutated-Fc), using two-cell and three-cell co-culture systems containing Natural Killer cells (NK-cells), dendritic cells (DCs) and various tumor cell lines of multiple cancer origins. We show a robust enhancement in NK-cell effector function, DC maturation, reciprocal NK:DC crosstalk and DC editing that is unique to avelumab treatment using multiple functional immune assays. By transcriptomic analysis, we show for the first time pivotal differences in gene sets involved in NK-cell effector function, DC maturation, immunoregulatory interactions, and cytokine production between innate immune cells treated with avelumab versus durvalumab. Furthermore, we report several previously unknown Fc-receptor-associated biological pathways uniquely triggered by avelumab. Our findings elucidate novel mechanisms of Fc-dependent actions of PD-L1 mAbs which may inform their use in future clinical trials.

2025-11-01·AMERICAN JOURNAL OF EMERGENCY MEDICINE

Underrecognized immune events in the emergency department among cancer patients on immune checkpoint inhibitors

Article

作者: Pekdemir, Murat ; Yaka, Elif ; Doğan, Nurettin Özgür ; Özturan, İbrahim Ulaş ; Karakayalı, Anıl ; Yılmaz, Gamze Kıvrak ; Yılmaz, Serkan

OBJECTIVES:

Cancer patients receiving immune checkpoint inhibitor (ICI) therapy frequently present to emergency departments (EDs) with immune-related adverse events (irAEs), yet ED-based recognition remains challenging. This study aimed to describe the frequency, causes, and characteristics of ED visits among cancer patients receiving ICI therapy, and to estimate the incidence, outline severity, and explore factors possibly associated with oncologist-adjudicated irAEs.

METHODS:

We conducted a single-center, retrospective chart review at a university hospital ED between January 2018 and August 2024. Adult cancer patients who received ICIs (avelumab, atezolizumab, pembrolizumab, ipilimumab, or nivolumab) and presented to the ED within 90 days of their most recent treatment were included. Data collected encompassed demographics, clinical presentations, ED evaluations, management, and outcomes. A blinded oncologist independently reviewed cases to identify irAEs using the Common Terminology Criteria for Adverse Events (CTCAE v5.0).

RESULTS:

Of 287 screened patients, 124 (43.2 %) visited the ED within 90 days post-ICI treatment, accounting for 291 ED visits. The most common presentations were fatigue, cough, and dyspnea. ED physicians explicitly diagnosed irAEs in only 3 out of 291 visits (1 %), while oncologist review identified irAEs in 40 cases (13.7 %). The predominant oncologist-adjudicated irAEs were myositis/myalgia (37.5 %) and pneumonitis (30 %). Most irAEs were low grade, with 90 % classified as CTCAE Grade 1 and 10 % as Grade 2; no Grade ≥ 3 events occurred.

CONCLUSION:

Only 1 % of encounters carried an explicit irAE discharge diagnosis, with most visits coded using symptom-based terms, indicating that irAEs are infrequently documented at discharge. Although nearly all missed irAEs were low grade, greater awareness and standardized multidisciplinary protocols may improve the identification, management, and outcomes of patients presenting with ICI-related toxicities.

2025-10-01·JOURNAL OF ONCOLOGY PHARMACY PRACTICE

Management and desensitization to Avelumab in anaphylaxis and metastatic urothelial carcinoma: A case report

Article

作者: Cadenas-García, Diana ; Villarreal-González, Rosalaura ; López-Galindo, Ángel ; Treviño-Morales, Ana Karen ; Vidal-Gutiérrez, Oscar

Introduction:

Urothelial carcinoma is the prevailing type of bladder cancer, characterized by expression of the programed death-ligand-1-protein (PD-L1). Avelumab is an anti-PD-L1 monoclonal antibody used in urothelial carcinoma. It is associated with an incidence of 47.4% and 25.2% in grade 3 adverse events or greater, respectively; gastrointestinal symptoms and cutaneous affections are the most common.

Case report:

A 52-year-old male with a history of rectal cancer and non-muscle-invasive bladder carcinoma. PET/CT revealed adenopathies in the pelvic region, the biopsy confirmed metastatic urothelial carcinoma. Next PET/CT indicated progression. Treatment with Cisplatin + Gemcitabine led to complete response after 4 cycles. Maintenance with Avelumab was indicated. Fifteen minutes after the first Avelumab administration, the patient experienced hypotension, presyncope, skin itching, and nasal congestion. Epinephrine, hydrocortisone, and physiological solution were administered, with resolution of symptoms.

Management & outcome:

Since Avelumab is first-line maintenance therapy in this patient, a desensitization protocol was performed with (3-bag, 12-steps). The patient was premedicated with acetaminophen and chlorpheniramine. The protocol was successfully completed without hypersensitivity reactions for 6 cycles.

Discussion:

Patients with hypersensitivity reactions to their first line of treatment are challenged to continue the best approach. We detail the case of a patient diagnosed with metastatic urothelial carcinoma who underwent a desensitization protocol for Avelumab after presenting a severe allergic reaction. The patient tolerated Avelumab throughout the protocol with no complications, achieving the total dosage for his maintenance therapy; drug desensitization is a safe and effective procedure in patients with hypersensitivity reactions to their first-line treatment.

520

项与阿维单抗相关的新闻（医药）

2025-09-03

·ETPharma

GST waiver for 36 drugs; formulations under 5% slab

New Delhi: Executing the much-awaited overhaul of the Goods and Services Tax (GST) regime, the GST Council has brought a major relief for patients by reducing the indirect tax on medicines to 5 per cent, along with exempting as many as 36 life-saving medicines and other critical drugs. The GST council—a statutory body highest decision making body on indirect taxes led by the Union Finance Ministry at its 56th meeting in the national capital has recommended to reduce the GST on all drugs and medicines (finished formulations) from 12 per cent to 5 per cent under the new two-tier tax structure of 5 and 18 per cent slabs to be effective from September 22. Additionally the body has also recommended to exempt GST on 33 lifesaving drugs and on 3 other medicines used for treatment of cancer, rare diseases and other severe chronic diseases. Speaking at a press briefing after the council 10.5-hour long marathon meet, Finance Minister Nirmala Sitharaman said, “all recommendations have been cleared with zero reservations and have corrected various inverted duty structure problems, classification related issues and that this rationalization exercise will bring predictability and stability of GST.” “These reforms have been carried out with a focus on the common man, and after a rigorous evaluation process in most sectors including healthcare, the rates have come down drastically, she added. Previously, medicines in India were taxed at 5 per cent for life-saving and essential drugs, and at 12 per cent for others but following the announcement all medicines will attract a standard duty of 5 per cent with extensions for several medicines specified at the end of this article. Welcoming the move, Sudarshan Jain, Secretary General, IPA said, “the decision to exempt life-saving and cancer medicines from GST, is a step that will bring direct relief to patients and their families. and, the reduction in GST on a wide range of medicines from 12 per cent to 5 per cent will further help to ease the overall treatment burden and make essential therapies more affordable.” Meanwhile, for companies, the clarity on a 5 per cent slab and exemptions removes long-standing ambiguity, enabling transparent pricing and better market planning. The move will expand access in semi-urban and rural markets, ease litigation, and free up resources for innovation, said Manoj Mishra, Partner and Tax Controversy Management Leader, Grant Thornton Bharat LLP. Notably, on the issue of inverted duty involving APIs and key starting materials—which are currently taxed at 18 per cent against 12 or 5 per cent for finished formulations—further clarity is awaited from the industry. ETPharma earlier reported that, in a letter to the Finance Minister, the national chemist body, the All India Organisation of Chemists and Druggists (AIOCD) had urged, “to bring all medicines including vitamins, probiotics, nutritional, food supplements under the 5 per cent GST slab. The rate rationalization comes days after Prime Minister Narendra Modi had pitched for introducing next-gen reforms across sectors to “increase ease of living for the common man and strengthen the economy.” However, this rationalization brings a revenue shortfall challenge for governments with states likely to bear a greater share of the burden, as they receive over 40 percent of the inter-state inflows in addition to their own SGST collections. Responding to a media query at the media briefing Arvind Shrivastava, Revenue Secretary said that, based on the consumption of FY23-24 the ministry has estimated that the net revenue implication of this proposal will be around Rs 48,000 crore. “However the exercise will trigger buoyancy effects and will have a positive impact on consumer and compliance. And therefore we believe this proposal will be fiscally sustainable both for centers and the states,” Shrivastava noted. ' S.no. Drug Indication Brand name and (Company) 1 Onasemnogene abeparvovec SMA (One-time gene therapy) Zolgensma (Novartis) 2 Asciminib Blood Cancer Scemblix (Novartis) 3 Mepolizumab Asthma Nucala (GSK) 4 Pegylated Liposomal Irinotecan Pancreatic Cancer Onivyde (Ipsen) 5 Daratumumab Cancer Darzalex (J&J subsidiary) 6 Daratumumab subcutaneous Cancer Darzalex Faspro (J&J subsidiary) 7 Teclistamab Blood Cancer Tecvayli (J&J subsidiary) 8 Amivantamab Lung Cancer Rybrevant (J&J subsidiary) 9 Alectinib Lung Cancer Alecensa (Roche) 10 Risdiplam SMA Evrysdi (Roche) 11 Obinutuzumab Blood Cancer Gazyva (Roche) 12 Polatuzumab vedotin Blood Cancer Polivy (Roche) 13 Entrectinib Cancer Rozlytrek (Roche) 14 Atezolizumab Cancer (PD-L1 immunotherapy) Tecentriq (Roche) 15 Spesolimab GPP flares Spevigo (Boehringer Ingelheim) 16 Velaglucerase Alpha Gaucher Vpriv (Takeda) 17 Agalsidase Alfa Fabry disease Replagal (Takeda) 18 Rurioctocog Alpha Pegol Hemophilia Adynovate (Takeda) 19 Idursulphatase Type II Mucopolysaccharidosis Elaprase (Takeda) 20 Alglucosidase Alfa Pompe Myozyme (Sanofi) 21 Laronidase Type I Mucopolysaccharidosis Aldurazyme (Sanofi) 22 Olipudase Alfa ASMD Xenpozyme (Sanofi) 23 Tepotinib Lung Cancer Tepmetko (Maerck KGaA) 24 Avelumab Cancer (PDL-1 immunotherapy) Bavencio (Pfizer) 25 Emicizumab Hemophilia Hemlibra (Roche subsidiary) 26 Belumosudil cGVHD - 27 Miglustat Gaucher Zavesca (J&J subsidiary) 28 Velmanase Alfa Alpha-mannosidosis - 29 Alirocumab Cholesterol lowering drug (LDL-C) Praluent (Sanofi) 30 Evolocumab Cholesterol lowering drug (LDL-C) Repatha (Amgen) 31 Cystamine Bitartrate Cystagon - 32 CI-Inhibitor injection Hereditary Angioedema - 33 Inclisiran Cholesterol lowering drug (LDL-C) Leqvio (Novartis) 34 Agalsidase Beta Fabry disease Fabrazyme (Sanofi) 35 Imiglucerase Gaucher Cerezyme (Sanofi) 36 Eptacog alfa activated recombinant coagulation factor VIIa Hemophilia NovoSeven Note: Above is the list of medicines exempted from GST tax recommended by the 56th GST Council Meet/ Source: PIB By Abhijeet Singh ,

基因疗法

2025-08-31

·ioncology

A-BRAVE研究结果公布，患者总生存曲线令人出乎意料

点击蓝字，关注我们三阴性乳腺癌的雌激素受体、孕激素受体和人类表皮生长因子受体HER2均为阴性，对传统的内分泌治疗和HER2靶向治疗无效，早期患者主要依靠手术和化疗。近年来，免疫检查点抑制剂已被证实对于晚期三阴性乳腺癌有效。免疫检查点是人体平衡免疫功能的两类分子，一类负责激活免疫细胞，另一类负责抑制免疫细胞，后者包括免疫细胞程序性死亡受体PD-1及其配体PD-L1，肿瘤细胞能够利用PD-1和PD-L1让免疫细胞进入自杀程序，避免自己被免疫细胞消灭，而PD-1或PD-L1抑制剂可以恢复免疫细胞抗肿瘤功能。不过，对于高风险早期三阴性乳腺癌，目前仅KEYNOTE-522研究证实PD-1抑制剂帕博利珠单抗术前新辅助治疗＋术后辅助治疗有效，可显著改善患者的病理完全缓解率、无事件生存和总生存，其他PD-1或PD-L1抑制剂已告失败。 2025年8月28日，欧洲肿瘤内科学会官方期刊《肿瘤学年鉴》在线发表意大利帕多瓦大学设计并发起的A-BRAVE研究报告，首次对PD-L1抑制剂阿维利尤单抗辅助治疗高风险早期三阴性乳腺癌术后患者的有效性和安全性进行随机比较。 A-BRAVE (NCT02926196): Adjuvant Treatment for High-risk Triple Negative Breast Cancer Patients With the Anti-PD-l1 Antibody Avelumab 该国际多中心非盲随机对照三期临床研究于2016年6月至2020年10月从60家意大利医院和7家英国医院入组高风险早期三阴性乳腺癌完成手术和化疗等标准治疗患者466例，按1比1随机分为两组，其中235例每2周静脉输注阿维利尤单抗治疗1年，其余231例观察。高风险分为两类：Ａ类83例（18%）初次手术后任何pT且≥pN2、pT2且pN1、pT3且pN0，Ｂ类383例（82%）术前化疗后乳腺和/或淋巴结残留浸润癌。主要终点包括全部患者和Ｂ类患者的无癌生存，次要终点包括全部患者的总生存和PD-L1测定患者的无癌生存，事后探索性分析终点包括全部患者的远处无癌生存。通过免疫组织化学和数字病理学对治疗前肿瘤样本PD-L1进行测定。若主要终点有统计学显著差异，则对次要终点进行统计学分析，否则仅进行描述性分析。结果，中位随访52.1个月，阿维利尤单抗组与观察组相比：全部患者3年无癌生存率相似：68.3%比63.2%（风险比：0.81，95%置信区间：0.61～1.09，P=0.172）Ｂ类患者3年无癌生存率相似：66.9%比60.7%（风险比：0.80，95%置信区间：0.58～1.10，P=0.170）全部患者3年总生存率较高：84.8%比76.3%（风险比：0.66，95%置信区间：0.45～0.97）全部患者3年远处无癌生存较高：75.4%比67.9%（风险比：0.70，95%置信区间：0.50～0.96） PD-L1阳性与阴性相比，患者3年无癌生存率较高：80.9%比64.2%（风险比：0.45，95%置信区间：0.26～0.78，P=0.003）。不过，阿维利尤单抗组与观察组相比： PD-L1阳性患者3年无癌生存率相似：67.5%比60.7%（风险比：1.72（95%置信区间：0.58～5.12） PD-L1阴性患者3年无癌生存率相似：84.8%比77.1%（风险比：0.76（95%置信区间：0.54～1.08） PD-L1不能预测阿维利尤单抗无癌生存获益（相互作用检验P=0.155）因此，该小规模研究短期随访结果表明，对于早期三阴性乳腺癌复发风险较高患者，完成手术和化疗等标准治疗后，阿维利尤单抗辅助治疗1年与观察相比，3年无癌生存并未改善。不过，出乎意料的是，描述性和探索性分析表明，阿维利尤单抗对3年总生存和远处无癌生存产生有利影响，可能减少远处转移和死亡风险，故有必要进一步长期随访并开展大规模研究进行验证，才能确定其对临床实践的潜在影响。PD-L1虽然可以预测患者无癌生存，但是不能预测阿维利尤单抗无癌生存获益。相关链接不可思议的乳腺癌患者总生存曲线 Ann Oncol. 2025 Aug 28. IF: 65.4 A-BRAVE trial: a Phase 3 randomized trial with anti-PD-L1 avelumab in high-risk triple-negative early breast cancer patients. Conte PF, Dieci MV, Bisagni G, Schmid P, Zambelli A, Piacentini F, De Laurentiis M, Favaretto AG, Tamberi S, Bianchi GV, Zamagni C, Cinieri S, Corsi DC, Del Mastro L, Ferro A, Gennari A, Mion M, Musolino A, Nicolé L, Del Bianco P, De Salvo GL, Guarneri V. University of Padova, Padova, Italy; Veneto Institute of Oncology IOV IRCCS, Padova, Italy; Azienda USL-IRCCS, Reggio Emilia, Italy; ASST Papa Giovanni XXIII, Bergamo, Italy; Bicocca University, Milan, Italy; University Hospital of Modena, Modena, Italy; Azienda Ospedaliero-Universitaria di Modena, Modena, Italy; Istituto Nazionale Tumori Napoli IRCCS "Fondazione Pascale", Napoli, Italy; Azienda ULSS 2 Marca Trevigiana, Treviso, Italy; Santa Maria delle Croci hospital, Ravenna, Italy; Fondazione IRCCS Istituto Nazionale Tumori Milano, Milan, Italy; IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy; Perrino Hospital, ASL Brindisi, Brindisi, Italy; Ospedale Isola Tiberina, Gemelli Isola Rome, Italy; IRCCS Ospedale Policlinico San Martino, Genova, Italy; Università degli Studi di Genova, Genova, Italy; Santa Chiara Hospital, Trento, Italy; Università del Piemonte Orientale, Novara, Italy; AULSS6 Camposampiero, Camposampiero, Italy; IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) Dino Amadori, Meldola, Italy; University of Bologna, Bologna, Italy; Angelo Hospital, Mestre, Italy; Queen Mary University of London, London, United Kingdom. HIGHLIGHTS A-BRAVE is a Phase III study of 1-year avelumab versus observation after standard treatment in high-risk TNBC. Avelumab as adjuvant therapy versus observation did not improve DFS in high-risk early TNBC patients OS analysis suggests a potential favorable impact of avelumab versus observation. PD-L1 status was not predictive for avelumab efficacy. BACKGROUND: The A-BRAVE trial evaluated the efficacy of avelumab, an anti PD-L1 antibody, as adjuvant treatment for patients with early triple-negative breast cancer (TNBC) at high-risk. PATIENTS AND METHODS: A-BRAVE is a Phase III study that randomized patients with high-risk early TNBC to 1-year avelumab vs observation, after completion of standard surgery and neoadjuvant/adjuvant chemotherapyHigh-risk was defined as either: 1) >pN2/any pT, pN1/pT2, or pN0/pT3 after primary surgery (Stratum A); or 2) invasive residual disease (breast and/or nodes) after neoadjuvant chemotherapy (Stratum B). Co-primary endpoints were disease-free survival (DFS) in the intention-to-treat (ITT) and Stratum B populations (). Secondary endpoints were overall survival (OS) and DFS in PD-L1-positive patients. PD-L1 was evaluated in treatment-naive tumor samples by immunohistochemistry (73-10 RUO assay, Agilent Technologies) and digital pathology. RESULTS: From June 2016 to October 2020, 466 patients were randomized: 383 entered Stratum B (82%) and 83 entered Stratum A (18%). At a median follow of 52.1 months, avelumab did not significantly improve DFS in the ITT population (HR 0.81, 95% CI 0.61-1.09, p=0.172; 3-year DFS estimates were 68.3% for avelumab versus 63.2%), or in Stratum B (HR 0.80, 95% CI 0.58-1.10, p=0.170; 3-year DFS estimates were 66.9% for avelumab versus 60.7%). In a descriptive analysis, avelumab reduced the hazard of OS events: HR 0.66, 95% CI: 0.45-0.97. The 3-year OS estimates for avelumab and control arm were 84.8% (95% CI: 79.5-88.8) and 76.3% (95% CI: 70.1-81.3), respectively. PD-L1 status resulted prognostic but not predictive for avelumab benefit in terms of DFS (test for interaction p=0.155). CONCLUSIONS: For patients with TNBC at high risk of relapse who complete standard treatment with surgery and neoadjuvant/adjuvant chemotherapy, 1 year of adjuvant avelumab versus observation did not improve DFS. However, a descriptive analysis suggests a potential favorable impact on OS. ClinicalTrials.gov identifier: NCT02926196 KEYWORDS: Breast cancer, clinical trial, immunotherapy, triple-negative breast cancer, PD-L1 DOI: 10.1016/j.annonc.2025.08.005 （来源：SIBCS）声明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

临床结果临床3期

2025-08-29

·EINPresswire

July - September 2021 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

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.

上市批准

100 项与阿维单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10817	阿维单抗	L01XC31	DB11945

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
肾细胞癌	澳大利亚	Merck Healthcare Pty Ltd.	2018-01-03
晚期肾细胞癌	欧盟	Merck Europe BV	2017-09-18
晚期肾细胞癌	冰岛	Merck Europe BV	2017-09-18
晚期肾细胞癌	列支敦士登	Merck Europe BV	2017-09-18
晚期肾细胞癌	挪威	Merck Europe BV	2017-09-18
局部晚期尿路上皮癌	欧盟	Merck Europe BV	2017-09-18
局部晚期尿路上皮癌	冰岛	Merck Europe BV	2017-09-18
局部晚期尿路上皮癌	列支敦士登	Merck Europe BV	2017-09-18
局部晚期尿路上皮癌	挪威	Merck Europe BV	2017-09-18
转移性Merkel细胞癌	欧盟	Merck Europe BV	2017-09-18
转移性Merkel细胞癌	冰岛	Merck Europe BV	2017-09-18
转移性Merkel细胞癌	列支敦士登	Merck Europe BV	2017-09-18
转移性Merkel细胞癌	挪威	Merck Europe BV	2017-09-18
转移性尿路上皮癌	欧盟	Merck Europe BV	2017-09-18
转移性尿路上皮癌	冰岛	Merck Europe BV	2017-09-18
转移性尿路上皮癌	列支敦士登	Merck Europe BV	2017-09-18
转移性尿路上皮癌	挪威	Merck Europe BV	2017-09-18
尿路上皮癌	美国	EMD Serono, Inc.	2017-05-09
梅克尔细胞癌	美国	EMD Serono, Inc.	2017-03-23

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
实体瘤	临床3期	美国	Merck KGaA	2019-03-22
实体瘤	临床3期	日本	Merck KGaA	2019-03-22
实体瘤	临床3期	阿根廷	Merck KGaA	2019-03-22
实体瘤	临床3期	澳大利亚	Merck KGaA	2019-03-22
实体瘤	临床3期	比利时	Merck KGaA	2019-03-22
实体瘤	临床3期	巴西	Merck KGaA	2019-03-22
实体瘤	临床3期	保加利亚	Merck KGaA	2019-03-22
实体瘤	临床3期	捷克	Merck KGaA	2019-03-22
实体瘤	临床3期	法国	Merck KGaA	2019-03-22
实体瘤	临床3期	德国	Merck KGaA	2019-03-22

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


Pubmed \| Urol Oncol	N/A	转移性尿路上皮癌	-	Avelumab + Docetaxel 75 mg/m²	遞廠齋鏇鑰壓淵鏇鏇鏇(糧衊襯鏇顧願鹹鹹鑰齋) = 1 dose-limiting toxicity (neutropenic fever) 築壓廠遞夢遞醖淵糧襯 (壓衊夢鏇製艱憲鬱餘鑰 )	-	2025-09-01
["Alliance A091802"] (Pubmed \| J Clin Oncol)	临床2期	皮肤鳞状细胞癌	57	Avelumab + Cetuximab	糧夢觸選衊顧襯觸遞艱(膚獵觸鹹製鏇齋鑰鬱艱) = 鹽顧鏇顧餘範淵鏇願構壓鑰築艱鬱積鬱鹽醖築 (鑰糧蓋範鏇簾遞夢糧鬱, 7.6 ~ NR) 更多	积极	2025-07-20
				Avelumab	糧夢觸選衊顧襯觸遞艱(膚獵觸鹹製鏇齋鑰鬱艱) = 觸願築觸廠壓齋積簾襯壓鑰築艱鬱積鬱鹽醖築 (鑰糧蓋範鏇簾遞夢糧鬱, 2.7 ~ 13.6) 更多
NCT03503630 (Averectal, ESMO_GI2025) 人工标引	临床2期	局部晚期直肠癌辅助 Microsatellite Stable (MSS)	40	Short-course radiotherapy (SCRT) + mFOLFOX-6 + Avelumab + TME	醖膚簾鑰繭鑰齋遞製鑰(壓膚窪壓鏇鑰艱壓簾願) = 壓艱糧簾窪築廠選襯膚範積壓齋網夢製壓鬱網 (夢壓製蓋鹹衊鬱鏇膚夢 ) 更多	积极	2025-07-03
NCT05327530 (JAVELIN Bladder Medley, ASCO2025) 人工标引	临床2期	晚期尿路上皮癌一线 \| 维持	-	Avelumab + Sacituzumab Govitecan	願襯餘遞衊鹽製膚鬱壓(膚製糧醖遞鹽構鹽繭齋) = 繭糧淵積壓夢願膚壓壓夢範夢製鏇觸膚窪蓋夢 (壓醖窪憲壓鑰艱築顧積, 7.43 ~ NE) 更多	积极	2025-05-30
				Avelumab	願襯餘遞衊鹽製膚鬱壓(膚製糧醖遞鹽構鹽繭齋) = 窪願繭糧鑰繭糧選鏇醖夢範夢製鏇觸膚窪蓋夢 (壓醖窪憲壓鑰艱築顧積, 3.32 ~ 6.77) 更多
MCC-TRIM (ASCO2025)	N/A	梅克尔细胞癌一线	875	avelumab (Immune-compromised (IC) patients)	壓廠鹹艱願壓憲積齋顧(艱鹽蓋憲蓋鹹憲遞簾齋) = 構鬱顧鹹膚鬱繭構糧獵夢艱膚獵選夢膚範餘醖 (糧築廠遞鹽範繭鹹繭製, 4.8 ~ 29.8)	积极	2025-05-30
				avelumab (Non-IC patients)	壓廠鹹艱願壓憲積齋顧(艱鹽蓋憲蓋鹹憲遞簾齋) = 選淵醖糧憲鑰鹹鏇選顧夢艱膚獵選夢膚範餘醖 (糧築廠遞鹽範繭鹹繭製, 15.7 ~ not estimable)
Javelin100 (ASCO2025)	N/A	转移性尿路上皮癌维持 PD-L1 status \| FGFR mutations	53	Avelumab	遞觸夢餘遞廠膚壓鑰淵(衊醖築簾艱範積憲築壓) = 觸鹽鹹壓膚淵願淵選餘衊鏇積廠壓構糧範選積 (範窪觸積鹽顧廠獵願齋, 1.8 ~ 40.6) 更多	积极	2025-05-30
NCT03047473 (SEJ, CTgov)	临床2期	多形性胶质母细胞瘤	38	avelumab	選夢積壓膚艱膚顧鏇鹽 = 鑰糧鑰鹹築積網積醖繭膚鹹鏇鬱糧鬱築簾製蓋 (鬱鑰觸襯願夢築網蓋範, 廠製簾夢憲構選壓窪遞 ~ 鑰夢淵憲窪鏇糧襯膚鹽) 更多	-	2025-05-25
NCT03674424 (AURA Oncodistinct-004, Pubmed \| J Immunother Cancer)	临床2期	肌层浸润性膀胱癌新辅助 Cisplatin-eligible \| Cisplatin-ineligible	137	Avelumab with ddMVAC	襯襯壓齋願齋夢餘簾簾(壓衊淵網蓋廠膚夢齋遞) = 範遞範築鑰鏇積糧壓衊繭網淵鏇糧壓窪觸齋艱 (範製壓衊網襯繭餘選鬱, 42 ~ 72) 更多	积极	2025-05-01
				Avelumab with GC	襯襯壓齋願齋夢餘簾簾(壓衊淵網蓋廠膚夢齋遞) = 範窪獵蓋蓋醖願齋遞鏇繭網淵鏇糧壓窪觸齋艱 (範製壓衊網襯繭餘選鬱, 37 ~ 68) 更多
Phase 2 trial (AACR2025)	临床2期	晚期尿路上皮癌 MTAP-deficiency	15	Pemetrexed	鬱衊顧艱構襯鹹範獵壓(鏇顧艱遞醖窪簾鑰顧淵) = 積淵憲餘壓窪憲簾繭構獵獵網鹹鏇廠繭鹽簾願 (願憲選廠鏇襯夢鏇簾積, 23% ~ 71%) 更多	积极	2025-04-28
NCT03217747 (Pubmed \| Oncologist)	临床1/2期	胃肠道肿瘤	-	Avelumab + Ivuxolimab	襯繭獵廠築鬱網艱製壓(蓋鏇夢願襯壓範襯鬱觸) = 廠壓淵淵遞鑰壓餘繭蓋壓積蓋鹽壓遞蓋願艱壓 (餘淵鏇蓋廠壓網壓築鹽 ) 更多	不佳	2025-03-10
				Avelumab + Ivuxolimab + Utomilumab	襯繭獵廠築鬱網艱製壓(蓋鏇夢願襯壓範襯鬱觸) = 鹹齋窪膚築餘積艱願顧壓積蓋鹽壓遞蓋願艱壓 (餘淵鏇蓋廠壓網壓築鹽 ) 更多