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Last update 05 Sep 2025

Bevacizumab

Last update 05 Sep 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

Bevacizumab(Genetical Recombination), rhuMAb-VEGF, 贝伐单抗

+ [17]

Target

VEGF-A

Action

inhibitors

Mechanism

VEGF-A inhibitors(Vascular endothelial growth factor A inhibitors), Angiogenesis inhibitors

Therapeutic Areas

NeoplasmsNervous System DiseasesDigestive System Disorders+ [11]

Active Indication

Unresectable Hepatocellular CarcinomaHepatocellular CarcinomaRecurrent Glioblastoma+ [218]

Inactive Indication

Acidemia, IsovalericAcute Basophilic LeukemiaAcute Eosinophilic Leukemia+ [281]

Originator Organization

Genentech, Inc.

Active Organization

National Cancer InstituteRoche Registration GmbHHoffmann-La Roche, Inc.

+ [26]

Inactive Organization

Roswell Park Comprehensive Cancer Center

The University of California, San Francisco

Celgene Corp.

+ [52]

License Organization

Roche Korea Co., Ltd.

Immune-Onc Therapeutics, Inc.

Roche Holding AG

+ [5]

Drug Highest PhaseApproved

First Approval Date

United States (26 Feb 2004),

Colonic CancerRectal Cancer

RegulationBreakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States)

Structure/Sequence

Sequence Code 41632H

Source: *****

Sequence Code 41637L

Source: *****

3,345

Clinical Trials associated with Bevacizumab

NCT06696768

/ RecruitingPhase 1IIT

Phase I Clinical Trial of CA-4948 (Emavusertib) in Combination With FOLFOX Plus Bevacizumab as Frontline Treatment in Patients With Metastatic Colorectal Cancer

This phase I trial studies the side effects and best dose of CA-4948 when given together with fluorouracil, leucovorin, oxaliplatin (FOLFOX) plus bevacizumab in treating patients with colorectal cancer that has spread from where it first started (primary site) to other places in the body (metastatic). CA-4948 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. The chemotherapy drugs used in FOLOX, fluorouracil and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Leucovorin is used with fluorouracil to treat colorectal cancer. Bevacizumab is in a class of medications called anti-angiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to the tumor. This may slow the growth and spread of the tumor. Giving CA-4948 with FOLFOX plus bevacizumab may be safe, tolerable and/or effective in treating patients with metastatic colorectal cancer.

Start Date23 Jan 2026

Sponsor / Collaborator

National Cancer Institute

NCT05375708

/ SuspendedPhase 2IIT

A Multicenter Phase II Randomized Trial to Evaluate Systemic Therapy Versus Systemic Therapy in Combination with Stereotactic Radiotherapy in Patients with Metastatic Colorectal Cancer

A small number of colorectal cancer patients with limited oligometastases may be candidates for local treatment of metastases (e.g., resection, ablation). However, it is unclear if patients with more extensive metastatic disease benefit from local therapies to control visible metastasis.
The purpose of this study is to assess the impact of stereotactic body radiation therapy (SBRT) in combination with systemic therapy compared to systemic therapy alone on safety and efficacy in patients with metastatic colorectal cancer (mCRC) and ≤10 metastases.

Start Date01 Dec 2025

Sponsor / Collaborator

University Medical Center of Utrecht

NCT06680258

/ Not yet recruitingPhase 3

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of TPST-1120 in Combination With Atezolizumab Plus Bevacizumab Compared With Placebo Plus Atezolizumab Plus Bevacizumab in Patients With Unresectable or Metastatic Hepatocellular Carcinoma (HCC) Not Previously Treated With Systemic Therapy

The goal of this clinical trial is to determine if TPST-1120 in combination with atezolizumab and bevacizumab helps patients to live longer compared to atezolizumab and bevacizumab alone (the standard of care treatment) in adult patients with hepatocellular carcinoma that cannot be removed by surgery or has spread outside of the liver (called metastatic). The trial also will study the safety and side effects of the drug combination compared to the standard of care treatment. Other questions the trial aims to answer include:
1. Does TPST-1120 in combination with atezolizumab and bevacizumab improve the time that patients are alive and cancer is not growing (progression free survival) compared to atezolizumab and bevacizumab
2. Does TPST-1120 in combination with atezolizumab and bevacizumab improve the shrinking of cancer (the overall response rate) compared to atezolizumab and bevacizumab
Trial participants will be randomly assigned to take one of the following:
1. TPST-1120 3 tablets (600 mg) by mouth twice a day every day along with atezolizumab 1200 mg intravenously every 3 weeks and bevacizumab 15 mg/kg intravenously every 3 weeks
2. Placebo (look-alike that does not contain study drug) 3 tablets by mouth twice a day every day along with atezolizumab 1200 mg intravenously once every 3 weeks and bevacizumab 15 mg/kg intravenously once every 3 weeks
Trial participants will receive routine and trial-specific cancer care from their study doctor including
* visits to the clinic every 3 weeks for physical examination, labs and questions about health and symptoms
* measurement of their cancer by CT scan every 9 weeks.
Trial participants can stop study treatment at any time they choose and for any reason. They also can continue to receive study treatment for as long as the treatment is controlling cancer growth and they are tolerating the drug effects.

Start Date01 Dec 2025

Sponsor / Collaborator

Tempest Therapeutics, Inc.

100 Clinical Results associated with Bevacizumab

100 Translational Medicine associated with Bevacizumab

100 Patents (Medical) associated with Bevacizumab

23,217

Literatures (Medical) associated with Bevacizumab

01 Apr 2026·DEN open

Long‐term results of palliative placement of very low‐axial force self‐expandable metallic stents for malignant colorectal obstruction

Article

Author: Moroi, Rintaro ; Kuwai, Toshio ; Yoshida, Shuntaro ; Enomoto, Toshiyuki ; Tomita, Masafumi ; Shiratori, Toshiyasu ; Kyo, Rika ; Saida, Yoshihisa ; Matsuzawa, Takeaki ; Isayama, Hiroyuki ; Sumida, Yorinobu ; Yamada, Tomonori ; Sasaki, Takashi

Abstract:

Objectives:

Stent placement is a standard option for palliative decompression in patients with malignant colorectal obstruction. Long‐term stent placement is associated with perforation, migration, and stent occlusion. Perforation is associated with life expectancy. Several studies have shown that stents with a high axial force (AF), which is defined as the force required to maintain the stent straight after it has bent, are associated with a higher perforation rate. Therefore, we evaluated the long‐term outcomes of using a very low AF stent (Niti‐S Enteral Colonic Uncovered stent D‐type) for palliative purposes.

Methods:

Eighty‐one consecutive patients with malignant colorectal obstruction in 33 medical institutions were evaluated. A stent with very low AF was placed using an endoscope system. We evaluated the adverse events (including perforation, migration, and stent occlusion), 1‐year survival rate, and cumulative patency rate. Univariate analysis was conducted using Fisher's exact test. The overall survival and cumulative patency rates were assessed using the Kaplan–Meier method.

Results:

The 1‐year cumulative survival rate was 37.8% after stent placement. The 3‐month, 6‐month, and 1‐year cumulative patency rates after stenting were 93.6%, 84.2%, and 75.8%, respectively. The major adverse events included stent migration (6.2%), stent occlusion (9.9%), and perforation (2.5%). Chemotherapy was administered in 26 cases (32.1%) after stenting, and bevacizumab was administered in five cases. However, no cases of perforation occurred following bevacizumab administration.

Conclusions:

Our results suggest that very low AF stents are safe and effective. Therefore, they may be a suitable option for applications, such as palliation. (UMIN 000011304)

31 Dec 2025·JOURNAL OF MEDICAL ECONOMICS

Cost-effectiveness analysis of regorafenib dose optimization for refractory metastatic colorectal cancer

Article

Author: Appukkuttan, Sreevalsa ; Cho, Sang Kyu ; Barzi, Afsaneh ; Grossman, Jamie ; Lee, Woojung ; Babajanyan, Svetlana ; Hocum, Brian ; Marian, Marisca ; Yang, Min ; Bekaii-Saab, Tanios

BACKGROUND:

New regimens have emerged as third-line or later therapies for metastatic colorectal cancer (mCRC), including regorafenib dose optimization (ReDO), trifluridine/tipiracil and bevacizumab (TAS-BEV) combination therapy, and fruquintinib. We evaluated relative cost-effectiveness of these therapies in patients with mCRC from a US payer's perspective.

MATERIALS AND METHODS:

A partitioned survival model (PSM) was constructed to estimate total costs and quality-adjusted life years (QALYs). Clinical parameters were obtained from pivotal trials of the respective therapies and incremental cost-effectiveness ratios (ICERs) were estimated to assess relative cost-effectiveness of these treatments. Model robustness was assessed using deterministic (DSA) and probabilistic sensitivity analysis (PSA). Three scenario analyses were conducted: (1) assuming equal efficacy across treatments, (2) with prior exposure to anti-vascular endothelial growth factor (VEGF) therapy, and (3) alternative clinical inputs for fruquintinib from a different clinical trial.

RESULTS:

Under the conventional willingness-to-pay (WTP) threshold in US ($150,000 per QALY gained), ReDO was cost-effective when compared with TAS-BEV and was dominant over fruquintinib. TAS-BEV was associated with an incremental QALY of 0.197 over ReDO, resulting in an ICER at $554,567 per QALY gained. The base case results were robust in DSA and PSA. Most influential parameters were treatment cost and effectiveness. In patients with prior anti-VEGF therapy, ReDO remained cost-effective compared to TAS-BEV and fruquintinib under the conventional WTP threshold.

LIMITATION:

Differences in trial populations may affect the comparability of the outcomes. Sensitivity and scenario analyses were conducted to address these limitations.

CONCLUSION:

ReDO was cost-effective compared with TAS-BEV from the US payer's perspective despite a higher QALY gain associated with TAS-BEV. ReDO was dominant over fruquintinib, consistently having a higher QALY gain and lower cost.

31 Dec 2025·JOURNAL OF MEDICAL ECONOMICS

Cost-efficiency and expanded access modeling of conversion to biosimilar bevacizumab in metastatic colorectal and non-squamous non-small cell lung cancer in Medicare

Article

Author: Bernauer, Mark ; Roth, Joshua A. ; Dorman, Stephanie ; Kratochvil, David

BACKGROUND:

Biosimilars to originator bevacizumab (Avastin), such as bevacizumab-bvzr (Zirabev), can deliver substantial savings and/or expanded access to biologic therapy for patients with metastatic colorectal (mCRC) and non-squamous non-small cell lung cancer (mNSCLC). The objective of this study is to explore the cost-efficiency and budget-neutral expanded access of bevacizumab-bvzr in mCRC and mNSCLC in Medicare.

METHODS:

We developed a Medicare payer perspective simulation model of patients treated for mCRC and mNSCLC to estimate cost-savings from converting bevacizumab (originator) to bevacizumab-bvzr or alternative biosimilars such as bevacizumab-awwb, -maly, and -abcd. The target patient population receiving annual first-line systemic therapy was calculated using Medicare enrollment data, SEER cancer incidence rates in patients age ≥65, and an assumption that 39.3% and 77.2% of new diagnoses receive systemic therapy for mCRC and mNSCLC respectively based on recent evidence. 76.0% of systemically treated mCRC patients and 11.4% of incident mNSCLC patients were expected to be treated with bevacizumab-based regimens based on recent evidence. Costs were derived from the 2024 Average Sales Price (ASP). Results include per-patient per-month (PPPM) cost savings (vs. originator), total monthly savings in the cohort, and number needed to convert (NNC) to biosimilar to fund the treatment of an additional 100 patients.

RESULTS:

PPPM savings from conversion to bevacizumab-bvzr were $4,205 in mCRC and $8,410 in mNSCLC. In 100% conversion scenarios, full cohort monthly savings were $27,664,432 in mCRC (n = 6,579) and $32,319,323 in mNSCLC (n = 3,843), respectively. At 100% conversion, monthly savings from biosimilar conversion could fund up to 13,887 additional mCRC patient-months of treatment with bevacizumab-bvzr + FOLFOX, and up to 8,959 additional mNSCLC patient-months of treatment with bevacizumab-bvzr + paclitaxel + carboplatin. In mCRC and mNSCLC the biosimilar NNC from the originator was 47 and 43, respectively. The biosimilar NNC from other biosimilars ranged from 60-4,564 and 55-4,422 for mCRC and NSCLC, respectively.

CONCLUSION:

In the first cost-efficiency and expanded access study of biosimilar bevacizumab in mCRC and mNSCLC, we find that bevacizumab-bvzr-based regimens can result in substantial cost savings relative to originator-based first line treatment in Medicare. These cost savings could be reinvested to treat a substantial number of additional patients with mCRC or mNSCLC, or fund other costs of care in Medicare, on a budget-neutral basis.

1,301

News (Medical) associated with Bevacizumab

02 Sep 2025

·www.globenewswire.com

Outlook Therapeutics Requests Type A Meeting with FDA

ISELIN, N.J., Sept. 02, 2025 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on optimizing the standard of care for bevacizumab for the treatment of retina diseases, today announced that a Type A Meeting request has been submitted to the U.S. Food and Drug Administration (FDA) to discuss the complete response letter (CRL) dated August 27, 2025 regarding the biologics license application (BLA) resubmission for ONS-5010, an investigational ophthalmic formulation of bevacizumab under development to treat wet AMD. In the FDA’s recently issued CRL, although the Agency acknowledged the NORSE TWO pivotal trial met its safety and efficacy endpoints, it recommended that confirmatory evidence of efficacy be submitted to support the application for ONS-5010. The requested Type A meeting seeks to clarify the details of the confirmatory evidence required by the FDA. “We believe this Type A meeting will provide us with additional clarity on the FDA’s requirements to remedy the deficiency identified in the CRL,” commented Bob Jahr, Chief Executive Officer of Outlook Therapeutics. “The Outlook Therapeutics team remains dedicated to our mission to provide patients in the U.S. with a safe and effective alternative to compounded bevacizumab, which has been used off-label as a first-line treatment for wet-AMD for years despite concerns around potency, sterility, consistency and regulatory oversight associated with the use of compounded products.” About ONS-5010/LYTENAVA™ (bevacizumab-vikg, bevacizumab gamma) ONS-5010/LYTENAVA™ is an ophthalmic formulation of bevacizumab for the treatment of wet AMD. LYTENAVA™ (bevacizumab gamma) is the subject of a centralized Marketing Authorization granted by the European Commission in the EU and Marketing Authorization granted by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK for the treatment of wet AMD. In the United States, ONS-5010/LYTENAVA™ (bevacizumab-vikg) is investigational. In certain European Union Member States ONS-5010/LYTENAVA™ must receive pricing and reimbursement approval before it can be sold. Bevacizumab-vikg (bevacizumab gamma in the EU and UK) is a recombinant humanized monoclonal antibody (mAb) that selectively binds with high affinity to all isoforms of human vascular endothelial growth factor (VEGF) and neutralizes VEGF’s biologic activity through a steric blocking of the binding of VEGF to its receptors Flt-1 (VEGFR-1) and KDR (VEGFR-2) on the surface of endothelial cells. Following intravitreal injection, the binding of bevacizumab to VEGF prevents the interaction of VEGF with its receptors on the surface of endothelial cells, reducing endothelial cell proliferation, vascular leakage, and new blood vessel formation in the retina. About Outlook Therapeutics, Inc. Outlook Therapeutics is a biopharmaceutical company focused on the development and commercialization of ONS-5010/LYTENAVA™ (bevacizumab-vikg, bevacizumab gamma) to optimize the standard of care for bevacizumab for the treatment of retina diseases. LYTENAVA™ (bevacizumab gamma) is the first ophthalmic formulation of bevacizumab to receive European Commission and MHRA Marketing Authorization for the treatment of wet AMD. Outlook Therapeutics commenced commercial launch of LYTENAVA™ (bevacizumab gamma) in Germany and the UK as a treatment for wet AMD. In the United States, ONS-5010/LYTENAVA™ (bevacizumab-vikg) is investigational. If approved in the United States, ONS-5010/LYTENAVA™, would be the first approved ophthalmic formulation of bevacizumab for use in retinal indications, including wet AMD. Forward-Looking Statements This press release contains forward-looking statements. All statements other than statements of historical facts are “forward-looking statements,” including those relating to future events. In some cases, you can identify forward-looking statements by terminology such as “anticipate,” “believe,” “continue,” “expect,” “intend,” “may,” “on track,” “plan,” “potential,” “seek,” “target,” “will,” or “would” the negative of terms like these or other comparable terminology, and other words or terms of similar meaning. These include, among others, plans to meet with the FDA, seek additional clarity on the FDA’s requirements to and work to address the deficiency identified in the CRL, the potential to obtain FDA approval for ONS-5010, the potential of ONS-5010/LYTENAVA™ as a treatment for wet AMD and to mitigate certain risks associated with the current off-label use of repackaged bevacizumab, and other statements that are not historical fact. Although Outlook Therapeutics believes that it has a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting Outlook Therapeutics and are subject to risks, uncertainties and factors relating to its operations and business environment, all of which are difficult to predict and many of which are beyond its control. These risk factors include those risks associated with developing and commercializing pharmaceutical product candidates, risks of conducting clinical trials and risks in obtaining necessary regulatory approvals, including the risk that the Outlook Therapeutics is unable to address the issues identified in the CRL and ultimately obtain FDA approval, the content and timing of decisions by regulatory bodies, the sufficiency of Outlook Therapeutics’ resources, as well as those risks detailed in Outlook Therapeutics’ filings with the Securities and Exchange Commission (the SEC), including the Annual Report on Form 10-K for the fiscal year ended September 30, 2024, filed with the SEC on December 27, 2024, as supplemented by the Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2025 and future reports Outlook Therapeutics files with the SEC, which include uncertainty of market conditions and future impacts related to macroeconomic factors, including as a result of the ongoing overseas conflicts, tariffs and trade tensions, fluctuations in interest rates and inflation and potential future bank failures on the global business environment. These risks may cause actual results to differ materially from those expressed or implied by forward-looking statements in this press release. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Outlook Therapeutics does not undertake any obligation to update, amend or clarify these forward-looking statements whether as a result of new information, future events or otherwise, except as may be required under applicable securities law. Investor Inquiries:Jenene ThomasChief Executive OfficerJTC Team, LLCT: 908.824.0775OTLK@jtcir.com

Drug Approval

02 Sep 2025

·www.prnewswire.com

Akeso Announces Completion of Patient Enrollment in Phase III Clinical Trial for Ivonescimab as First-Line Treatment for Biliary Tract Cancer Compared to PD-L1 Therapy

HONG KONG, Sept. 2, 2025 /PRNewswire/ -- Akeso (9926.HK) has recently announced the completion of patient enrollment in its Phase III, multicenter, randomized, controlled, registrational study evaluating ivonescimab, in combination with standard therapy, against durvalumab (PD-L1) combination therapy, for the first-line treatment of advanced biliary tract cancer (BTC) (AK112-309/HARMONi-GI1). This Phase III trial is being conducted in China. Ivonescimab has previously shown significant positive results in the randomized, double-blind, controlled Phase III study (HARMONi-2), where it was compared head-to-head with pembrolizumab. These results led to its approval as a first-line treatment for PD-L1-positive non-small cell lung cancer (NSCLC), marking its second approved indication. In addition, the Phase III trial of ivonescimab in combination with chemotherapy compared to tislelizumab combined with chemotherapy as a first-line treatment for squamous NSCLC, also delivered significant positive outcomes. These results highlight ivonescimab's strong clinical breakthroughs. Whether compared to PD-1 monotherapy, PD-1 plus chemotherapy (current standard therapies for various cancers), or VEGF-related treatments, ivonescimab has consistently demonstrated its ability to drive clinical innovation. Ivonescimab continues to validate its clinically meaningful profile and potential with a strategically expanded development program targeting key immuno-oncology settings: Phase III trials for Lung cancer (8 registrational/Phase III trials, 4 already met primary endpoints): First-line NSCLC, squamous and non-squamous (versus pembrolizumab + chemotherapy; global trial) First-line squamous NSCLC (versus tislelizumab + chemotherapy) NSCLC after progression on EGFR-TKI therapy (HARMONi-A and HARMONi studies) First-line PD-L1-positive NSCLC (versus pembrolizumab monotherapy) First-line PD-L1-high expressing NSCLC (versus pembrolizumab) IO-resistant NSCLC Consolidation therapy for limited-stage small cell lung cancer (LS-SCLC) without progression after concurrent chemoradiotherapy (cCRT) Phase III trials for core immuno-oncology indications (first-line therapy ): First-line biliary tract cancer (versus durvalumab + chemotherapy) First-line PD-L1-positive head and neck squamous cell carcinoma (HNSCC) in combination with ligufalimab (anti-CD47) versus pembrolizumab Phase III trials for cold tumors and more: First-line triple-negative breast cancer (TNBC) First-line MSS/pMMR colorectal cancer (representing about 95% of CRC cases) First-line pancreatic cancer Additional global Phase III trials are in advanced stages of planning An extensive clinical foundation includes over 20 Phase II studies across more than 10 additional tumor types, generating compelling efficacy and safety data that enable rapid transition to further registrational studies worldwide. Ivonescimab uniquely targets both PD-1 and VEGF, producing a synergistic anti-tumor effect. This dual mechanism not only combines the benefits of PD-1 and VEGF inhibition but also overcomes the efficacy and safety limitations of each target alone, resulting in pronounced clinical benefits. These advantages have been confirmed across multiple Phase III trials and real-world use, rapidly establishing ivonescimab as a next-generation leader in immunotherapy and anti-angiogenic therapy. For context, pembrolizumab (anti-PD-1) is approved for over 40 oncology indications, and bevacizumab (anti-VEGF) for more than 10. Akeso is implementing a dual-path strategy to maximize the value of ivonescimab worldwide: accelerating domestic commercialization and label expansion in China, while simultaneously advancing global development in partnership with Summit Therapeutics. Forward-Looking Statement of Akeso, Inc. This announcement by Akeso, Inc. (9926.HK, "Akeso") contains "forward-looking statements". These statements reflect the current beliefs and expectations of Akeso's management and are subject to significant risks and uncertainties. These statements are not intended to form the basis of any investment decision or any decision to purchase securities of Akeso. There can be no assurance that the drug candidate(s) indicated in this announcement or Akeso's other pipeline candidates will obtain the required regulatory approvals or achieve commercial success. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in P.R.China, the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Akeso's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the Akeso's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. Akeso does not undertake any obligation to publicly revise these forward-looking statements to reflect events or circumstances after the date hereof, except as required by law. About Akeso Akeso (HKEX: 9926.HK) is a leading biopharmaceutical company committed to the research, development, manufacturing and commercialization of the world's first or best-in-class innovative biological medicines. Founded in 2012, the company has created a unique integrated R&D innovation system with the comprehensive end-to-end drug development platform (ACE Platform) and bi-specific antibody drug development technology (Tetrabody) as the core, a GMP-compliant manufacturing system and a commercialization system with an advanced operation mode, and has gradually developed into a globally competitive biopharmaceutical company focused on innovative solutions. With fully integrated multi-functional platform, Akeso is internally working on a robust pipeline of over 50 innovative assets in the fields of cancer, autoimmune disease, inflammation, metabolic disease and other major diseases. Among them, 24 candidates have entered clinical trials (including 15 bispecific/multispecific antibodies and bispecific ADCs. Additionally, 7 new drugs are commercially available. Through efficient and breakthrough R&D innovation, Akeso always integrates superior global resources, develops the first-in-class and best-in-class new drugs, provides affordable therapeutic antibodies for patients worldwide, and continuously creates more commercial and social values to become a global leading biopharmaceutical enterprise. For more information, please visit and follow us on Linkedin. SOURCE Akeso, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3ImmunotherapyDrug ApprovalPhase 2Clinical Result

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

100 Deals associated with Bevacizumab

External Link

KEGG	Wiki	ATC	Drug Bank
D06409	Bevacizumab	L01XC07	DB00112

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Unresectable Hepatocellular Carcinoma	Japan	Chugai Pharmaceutical Co., Ltd.	25 Sep 2020
Hepatocellular Carcinoma	United States	Genentech, Inc.	29 May 2020
Recurrent Glioblastoma	United States	Genentech, Inc.	29 May 2020
Recurrent Primary Peritoneal Carcinoma	United States	Genentech, Inc.	14 Nov 2014
Ovarian Cancer	Japan	Chugai Pharmaceutical Co., Ltd.	22 Nov 2013
Glioma	Japan	Chugai Pharmaceutical Co., Ltd.	14 Jun 2013
Breast Cancer	Japan	Chugai Pharmaceutical Co., Ltd.	26 Sep 2011
Colorectal Cancer	Japan	Chugai Pharmaceutical Co., Ltd.	18 Sep 2009
Metastatic Renal Cell Carcinoma	United States	Genentech, Inc.	31 Jul 2009
Glioblastoma	United States	Genentech, Inc.	05 May 2009
Metastatic Colorectal Carcinoma	United States	Genentech, Inc.	05 May 2009
Ganglioglioma	Japan	Chugai Pharmaceutical Co., Ltd.	18 Apr 2007
Non-squamous non-small cell lung cancer	United States	Genentech, Inc.	11 Oct 2006
Fallopian Tube Carcinoma	European Union	Roche Registration GmbH	12 Jan 2005
Fallopian Tube Carcinoma	Iceland	Roche Registration GmbH	12 Jan 2005
Fallopian Tube Carcinoma	Liechtenstein	Roche Registration GmbH	12 Jan 2005
Fallopian Tube Carcinoma	Norway	Roche Registration GmbH	12 Jan 2005
Metastatic breast cancer	European Union	Roche Registration GmbH	12 Jan 2005
Metastatic breast cancer	Iceland	Roche Registration GmbH	12 Jan 2005
Metastatic breast cancer	Liechtenstein	Roche Registration GmbH	12 Jan 2005

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Advanced Head and Neck Carcinoma	Phase 3	United States	National Cancer Institute	13 Mar 2023
Cutaneous Squamous Cell Carcinoma of the Head and Neck	Phase 3	United States	National Cancer Institute	13 Mar 2023
Head and neck cancer metastatic	Phase 3	United States	National Cancer Institute	13 Mar 2023
Nasopharyngeal Carcinoma	Phase 3	United States	National Cancer Institute	13 Mar 2023
Nasopharyngeal Squamous Cell Carcinoma	Phase 3	United States	National Cancer Institute	13 Mar 2023
Oropharyngeal Neoplasms	Phase 3	United States	National Cancer Institute	13 Mar 2023
Recurrent Pharyngeal Squamous Cell Carcinoma	Phase 3	United States	National Cancer Institute	13 Mar 2023
Recurrent Squamous Cell Carcinoma of the Head and Neck	Phase 3	United States	National Cancer Institute	13 Mar 2023
Retinopathy of Prematurity	Phase 3	United States	Jaeb Center For Health Research Foundation, Inc.	27 Apr 2022
Retinopathy of Prematurity	Phase 3	Canada	Jaeb Center For Health Research Foundation, Inc.	27 Apr 2022

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04958811 (WCLC2025)	Phase 2	squamous cell lung carcinoma Second line PDL1 TPS ≥1%	12	bevacizumab+Atezolizumab+Tiragolumab	tnuoioodsy(hwpmyljsfb) = mmxnnuorex avfezvkpud (cdsifglipb ) View more	Positive	07 Sep 2025
NCT02681549 (Phase II Trial of Pembrolizumab in Combination With Bevacizumab for Untreated Melanoma Brain Metastases, CTgov)	Phase 2	Non-Small Cell Lung Cancer \| Metastatic melanoma \| Squamous non-small cell lung cancer ... View more	41	Pembrolizumab+Bevacizumab (Untreated Brain Metastases From Melanoma)	otiuxberta = ywktpaqfap lyffaxvemb (qhnuxouclf, pwrxocgpvm - rhacepeapj) View more	-	07 Aug 2025
				Pembrolizumab+Bevacizumab (Untreated Brain Metastases From NSCLC)	otiuxberta = ikigsvlgup lyffaxvemb (qhnuxouclf, twupdiodid - sqsrvcezzh) View more
NCT05357417 (U-BOMB, Pubmed \| JAMA Oncol) Manual	Phase 2	Metastatic HER2-Negative Breast Carcinoma HER2/Neu Negative	47	Utidelone +Bevacizumab	nciuepvrxm(cbvkqvyzyi) = vyjlwtanwa enypwxiguz (zaiknuqygm, 28.3 - 57.8) View more	Positive	01 Aug 2025
DUBHE-L-201 (Pubmed \| J Hematol Oncol) Manual	Phase 2	EGFR-mutated non-small Cell Lung Cancer EGFR Mutation	31	Iparomlimab and tuvonralimab (QL1706) + Bevacizumab + Chemotherapy (cohort 5)	jlznqtkrtu(nfusrxcmjg) = gyvzkmvthw yggrsewpiy (qbkgixjjpz, 12.81 - NR) View more	Positive	26 Jul 2025
				Iparomlimab and tuvonralimab (QL1706) + Bevacizumab + Chemotherapy (21L858R mutation + cohort 5)	jlznqtkrtu(nfusrxcmjg) = pxhbdntxpf yggrsewpiy (qbkgixjjpz ) View more
NCT03574779 (OPAL Phase II Trial \| OPAL, CTgov)	Phase 2	Ovarian Cancer	77	Niraparib+Bevacizumab+Dostarlimab (Cohort A (Dostarlimab + Bevacizumab + Niraparib))	sjwddzgelt = zqpuczupqh yconxbscij (pyecoohmbb, wvmapoaayz - uitotedjvw) View more	-	15 Jul 2025
				taxane+Niraparib (Cohort C (Niraparib OR Platinum-taxane))	sjwddzgelt = gycqdpzwsn yconxbscij (pyecoohmbb, chhewfkfud - nolfnzdksr) View more
NCT04712643 (TALENTACE, NEWS \| ASCO_GI2025) Manual	Phase 3	Malignant hepatoma non-resectable	342	TACE+阿替利珠单抗+贝伐珠单抗	zuwwhlshbz(jfqklxvfhr) = wkoefduuae lzmyzugoxp (ubdgtumduf ) View more	Positive	04 Jul 2025
				单独TACE	zuwwhlshbz(jfqklxvfhr) = zdikrullmm lzmyzugoxp (ubdgtumduf ) View more
NCT04487067 (AMETHISTA, ESMO_GI2025) Manual	Phase 3	Unresectable Hepatocellular Carcinoma First line	149	Atezolizumab plus bevacizumab	wwynyakzls(lrjhytbkyx) = iaqlmdqlfu mbrcgyivbo (iemaduveev ) View more	Positive	03 Jul 2025
NCT04732286 (ATHECA, ESMO_GI2025) Manual	Phase 3	Unresectable Hepatocellular Carcinoma First line	100	Atezolizumab + Bevacizumab	euevsnvuvt(weyrvtqhcf) = clhaygddup jaanutmdyl (xnkihsckij ) View more	Positive	03 Jul 2025
NCT04607421 (BREAKWATER, ESMO_GI2025) Manual	Phase 3	BRAF V600E mutant Colorectal Cancer First line BRAF V600E	243	FOLFOXIRI+bevacizumab (bev)	jmefenxuge(untsffalnw) = qbccqkyfwx apfzcuzlna (myadfumxux, 43.3 - 67.8) View more	Positive	03 Jul 2025
				mFOLFOX6+bevacizumab (bev)	jmefenxuge(untsffalnw) = kcqymphopp apfzcuzlna (myadfumxux, 29.1 - 48.1) View more
NCT05247619 (Pubmed \| EClinicalMedicine) Manual	Phase 2	Recurrent Cervical Cancer \| Uterine Cervical Cancer \| Metastatic Cervical Carcinoma First line	51	tislelizumab + bevacizumab +paclitaxel+cisplatin/tislelizumab + bevacizumab +paclitaxel+carboplatin	sfgxbtjifu(swlatbvwku) = vwnoglwppw vklamicpww (yviheabpxk, 14.6 - NR) View more	Positive	24 Jun 2025

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