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Last update 04 Dec 2025

Avelumab

Last update 04 Dec 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

Anti-CD274-monoclonal-antibody, Anti-PD-L1 monoclonal antibody, Avelumab (Genetical Recombination)

+ [11]

Target

PDL1

Action

inhibitors

Mechanism

PDL1 inhibitors(Programmed death-ligand 1 inhibitors)

Therapeutic Areas

NeoplasmsInfectious DiseasesUrogenital Diseases+ [8]

Active Indication

Renal Cell CarcinomaAdvanced Renal Cell CarcinomaLocally Advanced Urothelial Carcinoma+ [40]

Inactive Indication

Acute Myeloid LeukemiaAcute Promyelocytic LeukemiaAdenocarcinoma of Esophagus+ [77]

Originator Organization

Merck Serono SA

Active Organization

Merck KGaA

Pfizer Inc.Merck Europe BV

+ [6]

Inactive Organization

Vyriad, Inc.

Genome & Co.

Merck & Co., Inc.

+ [4]

License Organization

Nektar TherapeuticsMerck KGaA

NKGen Operating Biotech, Inc.

+ [12]

Drug Highest PhaseApproved

First Approval Date

United States (23 Mar 2017),

Merkel Cell Carcinoma

RegulationBreakthrough Therapy (United States), Fast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Priority Review (Australia), Orphan Drug (Japan)

Structure/Sequence

Sequence Code 166136L

Source: *****

Sequence Code 10219401H

Source: *****

300

Clinical Trials associated with Avelumab

NCT06557278

/ WithdrawnPhase 2

Phase II Open-Label Study to Assess the Safety and Efficacy of AlloStim® + Anti-PDL1 as Fourth Line Therapy in 4L MSS Metastatic Colorectal Cancer

Experimental immunotherapy in chemotherapy-refractory and immunotherapy-refractory metastatic colorectal cancer patients that have progressed, or are intolerant to, Longsurf (TAS-102) +/- Avastin (bevacizumab) or Stivarga (regorafenib) or Fruzaqla (fruquintinib) combining experimental AlloStim with an anti-programmed death ligand 1 (PD-L1) checkpoint inhibitor drug.

Start Date01 Nov 2026

Sponsor / Collaborator

Mirror Biologics Inc

CTIS2025-521738-27-00

/ Not yet recruitingPhase 2IIT

A Phase II Randomized Clinical Trial Comparing Two Cycles Versus Four Cycles of Combination Therapy with Cetuximab, Avelumab, Cisplatin, and Docetaxel in Patients with Recurrent Metastatic Head and Neck Cancer - AVETUX-HN

Start Date02 Dec 2025

Sponsor / Collaborator-

NCT07110038

/ Not yet recruitingPhase 2IIT

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.

Start Date01 Oct 2025

Sponsor / Collaborator

Astellas Pharma GmbH

[+2]

100 Clinical Results associated with Avelumab

100 Translational Medicine associated with Avelumab

100 Patents (Medical) associated with Avelumab

1,125

Literatures (Medical) associated with Avelumab

31 Dec 2025·JOURNAL OF MEDICAL ECONOMICS

Cost-effectiveness of enfortumab vedotin plus pembrolizumab as a first-line treatment of locally advanced or metastatic urothelial carcinoma in the United States

Article

Author: Bavle, Abhi ; Aout, Mounir ; Babcock, Aram ; Li, Haojie ; Zhang, Shujing ; Lai, Yizhen ; Mamtani, Ronac ; Notinger, Spencer ; Meng, Yang ; Brand-Wiita, Sarah

OBJECTIVE:

Enfortumab vedotin plus pembrolizumab (EV+Pem) was recently approved in the United States as the new first-line standard of care for locally advanced or metastatic urothelial carcinoma (la/mUC). We assessed the cost-effectiveness of EV+Pem as first-line treatment for la/mUC from a US third-party payer perspective, using the most recent database lock (data cutoff: 8 August 2024) from the Phase III EV302/KEYNOTE-A39 study (NCT04223856).

METHODS:

A partitioned survival model assessed the cost-effectiveness of EV+Pem versus gemcitabine and cisplatin/carboplatin followed by maintenance avelumab if not progressed (GP/GC ± Ave) in la/mUC patients. Standard and flexible spline parametric models were fitted to patient-level overall survival (OS) and progression-free survival (PFS) data from EV-302. Treatment discontinuation, utilities, and other clinical inputs were also based on EV-302. Cost inputs were sourced from literature or public databases. A cisplatin-eligible (Cis-E) subpopulation analysis compared EV+Pem versus nivolumab plus gemcitabine and cisplatin (Nivo + GP) and other platinum-based chemotherapies. A network meta-analysis based on the EV-302 and CheckMate-901 studies informed the OS and PFS hazard ratios for Nivo + GP versus EV+Pem.

RESULTS:

For the overall population, EV+Pem was projected to extend 2.58 life-years (LYs), or 1.76 quality-adjusted life-years (QALYs), versus GP/GC ± Ave, with an incremental cost-effectiveness ratio (ICER) of $180,631/QALY. Probabilistic sensitivity analyses (PSA) showed that EV+Pem had a 77% probability of being more cost-effective versus GP/GC ± Ave at a willingness-to-pay (WTP) threshold of $200,000/QALY. For the Cis-E subpopulation, EV+Pem was projected to extend 2.37 LYs (1.45 QALYs) versus Nivo + GP, with an ICER of $136,475/QALY. The PSA showed that EV+Pem had a 59% probability of being most cost-effective among all the treatment regimens considered, including platinum-based chemotherapies, at a WTP threshold of $200,000/QALY.

CONCLUSIONS:

EV+Pem is cost-effective compared to platinum-based regimens for the treatment of previously untreated la/mUC from a US third party payer perspective at a willingness-to-pay threshold of $200,000/QALY.

31 Dec 2025·RENAL FAILURE

Immune checkpoint inhibitor-induced nephrotic syndrome: a pharmacovigilance analysis of 404 FAERS cases and literature case series

Article

Author: Huang, Jiangfeng ; Wang, Zhi ; Ye, Jingjing ; Shao, Leping

Immune checkpoint inhibitor (ICI)-related nephrotic syndrome is a rare but increasingly reported adverse event, where early-onset severe cases warrant heightened vigilance. This pharmacovigilance study assessed this correlation by analyzing the U.S. Food and Drug Administration's Adverse Event Reporting System (FAERS) database from Q1 2011 to Q1 2025. A total of 404 cases of ICI-related nephrotic syndrome were identified in the FAERS database, with 84.1% of cases related to programmed cell death protein 1 (58.9%) or programmed death-ligand 1 (25.2%) inhibitors. Disproportionality signals were observed for six ICI monotherapies and one combination therapy: atezolizumab (ROR 6.84; 95% CI: 5.58-8.40), avelumab (ROR 5.54; 95% CI: 2.64-11.63), nivolumab (ROR 4.37; 95% CI: 3.64-5.25), pembrolizumab (ROR 3.44; 95% CI: 2.88-4.10), durvalumab (ROR 2.03; 95% CI: 1.12-3.66), ipilimumab (ROR 2.05; 95% CI: 1.07-3.94), and the combination therapy of nivolumab and ipilimumab (ROR 4.56; 95% CI: 3.56-5.83). Firth multivariate logistic regression analysis identified several independent risk factors, including advanced age (>65 years), malignant renal neoplasm, malignant mesothelioma, and the concomitant use of bevacizumab or lenvatinib. The median onset time was significantly shorter for severe cases than for non-severe cases (22.5 vs. 96.5 days, respectively; p = 0.0479). Additionally, a literature review of 18 cases provided supplementary information on the clinical features. This study provides vital pharmacovigilance insights regarding nephrotic syndrome related to ICIs, enhancing the understanding of its clinical implications.

01 Nov 2025·Urology Case Reports

Late cutaneous metastasis of clear-cell renal cell carcinoma to the lower eyelid five years after radical nephrectomy: A case report

Article

Author: Šuráň, Miroslav ; Liegertová, Michaela ; Milota, Jan ; Horák, Vít ; Broul, Marek ; Hujová, Aneta

Clear-cell renal cell carcinoma (ccRCC) metastasises widely, but cutaneous spread is uncommon and eyelid involvement exceptionally rare. We report a 55-year-old man who developed a painless 4-mm lower-eyelid nodule five years after curative left radical nephrectomy for pT1a ccRCC. Excision confirmed metastatic ccRCC (PAX8+, CD10⁺). Staging showed mediastinal nodal and pulmonary disease. First-line avelumab 800 mg IV every two weeks plus axitinib was initiated; in July 2025 axitinib was reduced to 5 mg once daily. After eight cycles, interim CT (August 2025) demonstrated regression with no locoregional recurrence. This case highlights continued vigilance and prompt biopsy of atypical eyelid lesions.

369

News (Medical) associated with Avelumab

03 Sep 2025

·pharma.economictimes.indiatimes.com

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 ,

Gene Therapy

29 Aug 2025

·www.einpresswire.com

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.

Drug Approval

29 Aug 2025

·www.einpresswire.com

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

Addyi (flibanserin) Drug hypersensitivity The "Contraindications", "Warnings and Precautions", "Adverse Reactions", and "Medication Guide" sections of the labeling were updated in September 2021 to include hypersensitivity reactions. Addyi labeling Glucagon-like peptide-1 (GLP-1) analogues Adlyxin (lixisenatide) Bydureon (exenatide) Bydureon BCise (exenatide) Byetta (exenatide) Ozempic (semaglutide) Rybelsus (semaglutide) Saxenda (liraglutide) Soliqua (insulin glargine and lixisenatide) Trulicity (dulaglutide) Victoza (liraglutide) Xultophy (insulin degludec and liraglutide) Drug-induced liver injury The "Adverse Reactions" section of the liraglutide and dulaglutide labeling was updated in June 2022 to include information about elevations of liver enzymes. Example: Trulicity labeling FDA determined that no action is necessary at the time for lixisenatide, exenatide, and semaglutide based on available information. Alcohol-based hand sanitizers Exposure via inhalation FDA determined that no action is necessary at the time based on available information. A FDA Drug Safety Communication was issued on June 16, 2021. Amlodipine and Levamlodipine Products Azor (amlodipine and olmesartan medoxomil ) Caduet (amlodipine besylate and atorvastatin calcium) Conjupri (levamlodipine maleate) Consensi (amlodipine besylate and celecoxib) Exforge (amlodipine and valsartan) Exforge HCT (amlodipine/valsartan and hydrochlorothiazide) Lotrel (amlodipine besylate and benazepril hydrochloride) Katerzia (amlodipine benzoate) Norvasc (amlodipine besylate) Prestalia (amlodipine besylate and perindopril arginine) Tribenzor (amlodipine besylate/olmesartan medoxomil and hydrochlorothiazide) Twynsta (amlodipine and telmisartan) Non-cardiogenic pulmonary edema FDA determined that no action is necessary at the time based on available information. Avonex (interferon beta-1a) Betaseron (interferon beta-1b) Extavia (interferon beta-1b) Plegridy (pegylated interferon beta-1a) Rebif (interferon beta-1a) Injection site abscess FDA is evaluating the need for regulatory action. Bavencio (avelumab) Imfinzi (durvalumab) Keytruda (pembrolizumab) Libtayo (cemiplimab-rwlc) Opdivo (nivolumab) Tecentriq (atezolizumab) Scleroderma FDA determined that no action is necessary at the time based on available information. Bavencio (avelumab) Imfinzi (durvalumab) Keytruda (pembrolizumab) Libtayo (cemiplimab-rwlc) Opdivo (nivolumab) Tecentriq (atezolizumab) Cholangitis sclerosing The "Adverse Reactions" section of the Keytruda (pembrolizumab) labeling was updated in August 2021 to include sclerosing cholangitis. Example: Keytruda labeling FDA determined that no action is necessary at the time for Bavencio (avelumab), Imfinzi (durvalumab), Libtayo (cemiplimab-rwlc), Opdivo (nivolumab), and Tecentriq (atezolizumab) based on available information. Chloroquine Generic products containing chloroquine Phospholipidosis The “Warnings” section of the labeling was updated in May 2022 to include information about phospholipidosis. Eliquis (apixaban) Pradaxa (dabigatran etexilate mesylate) Savaysa (edoxaban tosylate) Xarelto (ribaroxaban) Generic products containing dabigatran etexilate mesylate Generic products containing ribaroxaban Menorrhagia The “Use in Specific Populations” section was updated April 2021 to add language to describe the risk of clinically significant uterine bleeding in females of reproductive potential. Eliquis label Pradaxa label Savaysa label Xarelto label Depakote (divalproex sodium) Depakote ER (divalproex sodium) Stavzor (valproic acid) Generic products containing divalproex sodium Generic products containing valproic acid Tubulointerstitial nephritis The "Adverse Reactions" section of the labeling was updated in November 2021 to include tubulointerstitial nephritis. Example: Depakote labeling Dupixent (dupilumab) Alopecias FDA is evaluating the need for regulatory action. H.P. Acthar Gel (corticotropin) Anaphylactic and anaphylactoid responses The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in October 2021 to include anaphylaxis. Acthar Gel labeling H.P. Acthar Gel (corticotropin) Cardiac arrhythmias The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in October 2021 to include atrial fibrillations and palpitations. Acthar Gel labeling Ibrance (palbociclib) Kisqali (ribociclib) Kisqali Femara Co-Pack (letrozole and ribociclib) Verzenio (abemaciclib) Second primary malignancy FDA determined that no action is necessary at the time based on available information. Lynparza (olaparib) Drug-induced liver injury FDA determined that no action is necessary at the time based on available information. Ocrevus (ocrelizumab) Autoimmune colitis The "Warnings and Precautions", "Adverse Reactions", "Patient Counseling Information", and "Medication Guide" sections of the labeling were updated in August 2022 to include colitis. Ocrevus labeling Poteligeo (mogamulizumab-kpkc) Acute kidney injury The "Warnings and Precautions" section of the labeling was updated in March 2022 to include glomerulonephritis. Poteligeo labeling Ravicti (glycerol phenylbutyrate) Product labeling issue regarding stability and instructions for administration The container label, carton label, "Medication Guide", and sections of the Prescribing Information ("Dosage and Administration" and "Patient Counseling Information") were updated in September 2021 to enhance the instructions for administration. Ravicti labeling Spravato (esketamine) Hypertensive crisis FDA determined that no action is necessary at the time based on available information. Tremfya (guselkumab) Device use errors resulting in possible missed or partial doses The Tremfya One Press Instructions for Use (IFU) and carton labeling was updated in June 2023 to mitigate medication errors, such as underdose or no dose delivered. Tremfya labeling Trulance (plecanatide) Drug hypersensitivity The “Adverse Reactions” section of the Trulance labeling was updated April 2021 to include skin itching, hives, and rash. Trulance Label Trulance (plecanatide) Vomiting The “Adverse Reactions” section of the Trulance labeling was updated April 2021 to include vomiting. Trulance Label 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.

Drug Approval

100 Deals associated with Avelumab

External Link

KEGG	Wiki	ATC	Drug Bank
D10817	Avelumab	L01XC31	DB11945

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Renal Cell Carcinoma	Australia	Merck Healthcare Pty Ltd.	03 Jan 2018
Advanced Renal Cell Carcinoma	European Union	Merck Europe BV	18 Sep 2017
Advanced Renal Cell Carcinoma	Iceland	Merck Europe BV	18 Sep 2017
Advanced Renal Cell Carcinoma	Liechtenstein	Merck Europe BV	18 Sep 2017
Advanced Renal Cell Carcinoma	Norway	Merck Europe BV	18 Sep 2017
Locally Advanced Urothelial Carcinoma	European Union	Merck Europe BV	18 Sep 2017
Locally Advanced Urothelial Carcinoma	Iceland	Merck Europe BV	18 Sep 2017
Locally Advanced Urothelial Carcinoma	Liechtenstein	Merck Europe BV	18 Sep 2017
Locally Advanced Urothelial Carcinoma	Norway	Merck Europe BV	18 Sep 2017
Metastatic Merkel Cell Carcinoma	European Union	Merck Europe BV	18 Sep 2017
Metastatic Merkel Cell Carcinoma	Iceland	Merck Europe BV	18 Sep 2017
Metastatic Merkel Cell Carcinoma	Liechtenstein	Merck Europe BV	18 Sep 2017
Metastatic Merkel Cell Carcinoma	Norway	Merck Europe BV	18 Sep 2017
Metastatic urothelial carcinoma	European Union	Merck Europe BV	18 Sep 2017
Metastatic urothelial carcinoma	Iceland	Merck Europe BV	18 Sep 2017
Metastatic urothelial carcinoma	Liechtenstein	Merck Europe BV	18 Sep 2017
Metastatic urothelial carcinoma	Norway	Merck Europe BV	18 Sep 2017
Transitional Cell Carcinoma	United States	EMD Serono, Inc.	09 May 2017
Merkel Cell Carcinoma	United States	EMD Serono, Inc.	23 Mar 2017

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Solid tumor	Phase 3	United States	Merck KGaA	22 Mar 2019
Solid tumor	Phase 3	Japan	Merck KGaA	22 Mar 2019
Solid tumor	Phase 3	Argentina	Merck KGaA	22 Mar 2019
Solid tumor	Phase 3	Australia	Merck KGaA	22 Mar 2019
Solid tumor	Phase 3	Belgium	Merck KGaA	22 Mar 2019
Solid tumor	Phase 3	Brazil	Merck KGaA	22 Mar 2019
Solid tumor	Phase 3	Bulgaria	Merck KGaA	22 Mar 2019
Solid tumor	Phase 3	Czechia	Merck KGaA	22 Mar 2019
Solid tumor	Phase 3	France	Merck KGaA	22 Mar 2019
Solid tumor	Phase 3	Germany	Merck KGaA	22 Mar 2019

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASN2025	Not Applicable	Advanced Renal Cell Carcinoma First line	886	Axitinib plus Avelumab	tihhtgvvmf(ijlfuuqlaz) = cuidsznvts tmgoguonbf (zszcpevgkd ) View more	Positive	08 Nov 2025
				Sunitinib	msqhkutzae(bshoznpwvp) = zapwvkejtr pdnddpcgmb (tgijhdmbxm )
NCT05947500 (MATRiX, SITC2025)	Phase 2	Merkel Cell Carcinoma	24	Tuvusertib	fzoedwwqtk(xyjytynecp) = vkolvwbbfu jjvattrkxb (hxrvuxamtp )	Positive	05 Nov 2025
				Tuvusertib + Avelumab	fzoedwwqtk(xyjytynecp) = bodjeqohlz jjvattrkxb (hxrvuxamtp )
NCT03747419 (CTgov)	Phase 2	Muscle Invasive Bladder Urothelial Carcinoma \| Muscle Invasive Bladder Carcinoma	14	Radiation+Avelumab	aekzprdhnr(ysjkwyznhi) = htnlodnibh zpqfijvmch (djvblmfmgc, egdrujksss - zlhvqxbaxf) View more	-	31 Oct 2025
NCT04266912 (CTgov)	Phase 1/2	Refractory Malignant Solid Neoplasm \| Metastatic Solid Tumor \| Advanced Malignant Solid Neoplasm ... View more	23	Berzosertib+Avelumab (Escalation Dose Level 1)	cudwicbrjk = igajoiwjjy eyqgkmojwj (ejkkoxwenj, jgrtqrttbt - cyrifkumza) View more	-	20 Oct 2025
				Berzosertib+Avelumab (Escalation Dose Level 2)	cudwicbrjk = nspgrvkymw eyqgkmojwj (ejkkoxwenj, vegrdybexq - diiatjqjnl) View more
NCT03391479 (ALPACA, ESMO2025)	Phase 2	Penile Neoplasms	23	Avelumab 10 mg/kg IV	zfriwgloir(gowkmaghlm) = grade ≥3 events were infrequent (4% each) and included infusion reaction, fatigue, rash, anemia, and arthralgia. jildwziuhy (vuqmjurmfe )	Positive	17 Oct 2025
NCT03288350 (ESMO2025)	Phase 2	Locally Advanced Gastroesophageal Junction Adenocarcinoma dMMR	50	Avelumab + mDCF	dwsvzsvupy(kccolokglr) = axawtnuwrt kggukgwjox (bckernythy ) View more	Positive	17 Oct 2025
NCT06892860 (DISCUS, ESMO2025)	Phase 2	Advanced Urothelial Carcinoma	267	3 cycles of gemcitabine/cisplatin or gemcitabine/carboplatin	jvdmjcdlgr(tkplttsmea) = ovalxazmfo vuuvnzkkyz (ffkfpsdwzz, -5.9 to 5.2) View more	Positive	17 Oct 2025
				6 cycles of gemcitabine/cisplatin or gemcitabine/carboplatin	jvdmjcdlgr(tkplttsmea) = mkxnvbknge vuuvnzkkyz (ffkfpsdwzz, -14.1 to -2.9) View more
JAVELIN Renal 101 (ESMO2025)	Phase 3	Renal Cell Carcinoma First line	50	ICI+VEGF TKI	lplutxeaeu(mswffruhsi) = ER pts had significantly higher circulating levels of the pro-inflammatory cytokines IL1-Beta (p=0.033) oicurecwbh (lbaxqlnybp ) View more	Positive	17 Oct 2025
				ICI+VEGF TKI (pts with PD)
NCT03990571 (ESMO2025)	Phase 2	Adenoid Cystic Carcinoma NOTCH1 mutations \| MYC upregulation \| TP63 upregulation	22	Axitinib plus Avelumab	pzaobstzwm(yyotectzol) = ryisvjnvwg cinykpizwq (ruswtcgucm )	Positive	17 Oct 2025
ESMO2025	Not Applicable	Locally Advanced Cervical Carcinoma Neoadjuvant	20	Avelumab + Bevacizumab + Chemotherapy	yzmmtdnyoj(uooocnyfml) = 5 patients (25%) failed to pursue the protocol as it is because of grade I/II neutropenia and fatigue, therefore, their treatment was modified according to each case in order to cope with toxicity profile. dbwrqfwpcw (bqktngksnp )	Positive	17 Oct 2025

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