Bevacizumab
- Generic Name
- Bevacizumab
- Brand Names
- Avastin, Mvasi, Oyavas, Alymsys, Aybintio, Abevmy, Vegzelma, Onbevzi, Zirabev, Lytenava, Avzivi
- Drug Type
- Biotech
- CAS Number
- 216974-75-3
- Unique Ingredient Identifier
- 2S9ZZM9Q9V
- Background
There is a great deal of evidence indicating that vascular endothelial growth factor (VEGF) is important for the survival and proliferation of cancer cells. VEGF plays an important role in angiogenesis, lymphangiogenesis, and tumor growth, which are all factors that contribute to its attractiveness as a therapeutic target for anti-cancer therapies.
In 2004, bevacizumab (Avastin) gained FDA approval for specific types of cancer, and became the first antiangiogenic agent introduced to the market. It is a humanized monoclonal IgG antibody, and inhibits angiogenesis by binding and neutralizing VEGF-A. Bevacizumab is generally indicated for use in combination with different chemotherapy regimens which are specific to the type, severity, and stage of cancer. Bevacizumab was approved by Health Canada on March 24, 2010 and by the European Commission on April 21, 2021. There are also biosimilars of bevacizumab available, such as bevacizumab-awwb, bevacizumab-maly, and bevacizumab-adcd.
Interestingly, researchers have identified higher VEGF expression in patients with COVID-19, which may contribute to lung pathologies including acute respiratory syndrome (ARDS) and acute lung injury (ALI). As such, bevacizumab is being investigated for the treatment of lung complications associated with severe cases of COVID-19.
- Indication
As a vascular endothelial growth factor (VEGF) inhibitor, bevacizumab is used in several chemotherapy regimens to treat metastatic colorectal cancer; metastatic, unresectable, locally advanced or recurrent non-squamous non-small cell lung cancer; metastatic renal cell carcinoma; metastatic, persistent, or recurrent cervical cancer; primary peritoneal cancer; epithelial ovarian cancer; fallopian tube cancer; breast cancer; and recurrent glioblastoma.
Interestingly, bevacizumab is currently under investigation for the treatment of COVID-19 complications including acute respiratory distress syndrome (ARDS) and acute lung injury (ALI).
- Associated Conditions
- Metastatic Breast Cancer, Metastatic Cervical Cancer, Metastatic Colorectal Cancer (CRC), Metastatic Non-squamous Non Small Cell Lung Cancer, Metastatic Renal Cell Carcinoma ( mRCC), Persistent Cervical Cancer, Recurrent Cervical Cancer, Recurrent Glioblastoma, Relapsed Glioblastoma, Stage III Fallopian Tube Cancer, Stage III Ovarian Epithelial Cancer, Stage III Primary Peritoneal Cancer, Stage IV Fallopian Tube Cancer, Stage IV Ovarian Epithelial Cancer, Stage IV Primary Peritoneal Cancer, Locally advanced nonsquamous non-small cell lung cancer, Recurrent Non-Squamous Non-Small Cell Lung Cancer, Recurrent Platinum-Sensitive Epithelial Ovarian Cancer, Recurrent Platinum-resistant Epithelial Ovarian Cancer, Recurrent platinum drug resistant Fallopian tube cancer, Recurrent platinum drug resistant primary peritoneal cancer, Recurrent platinum sensitive primary peritoneal cancer, Recurrent platinum-sensitive fallopian tube cancer, Unresectable Non-Squamous Non-Small Cell Lung Cancer, Unresectable, advanced Non-squamous Non-small-cell Lung Cancer (NSQ NSCLC)
- Associated Therapies
- First Line Chemotherapy, First or Second Line Therapy, Second Line Treatment
Tecentriq and Avastin Combined with TACE Shows Significant Benefit in Unresectable Liver Cancer Trial
• The Phase III TALENTACE study demonstrated statistically significant improvement in TACE-progression-free survival for patients with unresectable hepatocellular carcinoma treated with Tecentriq, Avastin, and on-demand TACE.
• This landmark trial enrolled 342 patients across China and Japan, marking the first Phase III study in Asia showing TACE PFS benefit from combining immunotherapy and targeted therapy with TACE for unresectable HCC.
• Liver cancer remains the third leading cause of cancer-related death globally with rising mortality rates, with only 20% of patients surviving five years after diagnosis.
GSK and iTeos Terminate TIGIT Cancer Drug Development After Phase 2 Failure
• GSK and iTeos Therapeutics have discontinued development of belrestotug, their TIGIT-targeting immunotherapy, after it failed to significantly delay tumor progression in non-small cell lung cancer patients.
• The companies are terminating all ongoing trials, including a Phase 3 study, ending their four-year collaboration that began with GSK's $625 million upfront payment and potential $1.45 billion in milestone payments.
• iTeos is now conducting a strategic review to preserve capital, as the failure eliminates its most advanced drug candidate and represents another setback for TIGIT-targeting therapies in oncology.
CNS Pharmaceuticals Secures Orphan Drug Designation for TPI 287 in Brain Cancer Treatment
• CNS Pharmaceuticals has successfully acquired Orphan Drug Designation from Cortice Biosciences for TPI 287, a novel abeotaxane with potential to cross the blood-brain barrier for treating brain tumors.
• In early clinical trials, TPI 287 combined with bevacizumab showed promising efficacy against glioblastoma multiforme (GBM), with 3 complete responses and 9 partial responses among 23 evaluable patients.
• The company plans to begin patient enrollment for a Phase 2 study by the end of 2025, with the Orphan Drug status potentially providing seven years of market exclusivity upon approval.
Leap Therapeutics Halves Workforce and Refocuses Cancer Drug Development Amid Market Challenges
• Leap Therapeutics has announced a significant restructuring, reducing its workforce by approximately 50% and narrowing the development focus of its lead cancer drug candidate in response to challenging market conditions.
• The strategic pivot aims to extend the company's cash runway while concentrating resources on the most promising clinical applications of its lead oncology asset, potentially improving its chances for regulatory success.
• This move follows similar restructuring trends across the biotech sector, with companies like Arcturus, NGM Bio, and Erasca all recently announcing staff reductions and pipeline reprioritizations to navigate the difficult funding environment.
BioNTech's BNT327 Shows Promising 85% Response Rate in First-Line Treatment for Extensive-Stage SCLC
• BNT327, a bispecific antibody targeting both PD-L1 and VEGF-A, demonstrated an 85.4% confirmed response rate when combined with chemotherapy in extensive-stage small cell lung cancer patients.
• The phase 2 trial showed impressive disease control in 97.9% of patients, with 12-month overall survival rates of 72.7%, suggesting potential improvement over current standard treatments.
• Despite 86% of patients experiencing grade 3 or higher treatment-related adverse events, the safety profile was considered manageable with only 6% discontinuing treatment and no treatment-related deaths reported.
Robust Pipeline of 200+ Therapies Targets Colorectal Cancer Treatment Landscape
• DelveInsight's latest report reveals a robust pipeline with over 195 companies developing 200+ therapies for colorectal cancer, highlighting significant innovation in targeted treatments and immunotherapies.
• Key drug candidates include XL092 (Exelixis), Adagrasib (Mirati Therapeutics), Olaparib (Merck/AstraZeneca), and novel approaches like LYL845, an autologous tumor-infiltrating lymphocyte therapy from Lyell Immunopharma.
• The metastatic colorectal cancer segment shows particular promise with 150+ companies advancing 180+ pipeline therapies, including innovative treatments targeting specific mutations and immune pathways.
Brain Hemorrhage Treatment Market Expected to Grow Significantly by 2032 as AI Solutions Gain FDA Approval
• The brain hemorrhage treatment market is projected to experience substantial growth through 2032, driven by an aging population and increasing prevalence of risk factors such as hypertension and traumatic brain injuries.
• Recent FDA approvals for AI-based diagnostic tools, including JLK-LVO and Heuron ICH, mark significant advancements in early detection and treatment of brain hemorrhages.
• Several pharmaceutical companies including Baxter, Pfizer, and Novartis are developing promising pipeline therapies such as tissue plasminogen activator, alteplase, and BAF312 to address the significant unmet needs in brain hemorrhage treatment.
Luveltamab Tazevibulin Shows Promising Results in Platinum-Resistant Ovarian Cancer with Low to High FRα Expression
• Luveltamab tazevibulin demonstrated a 32% overall response rate in platinum-resistant ovarian cancer patients with FRα expression ≥25%, showing similar efficacy in both low-medium and high expression subgroups.
• The antibody-drug conjugate achieved a remarkable 96% disease control rate when administered at 5.2 mg/kg with G-CSF prophylaxis for the first two cycles, then 4.3 mg/kg in subsequent cycles.
• Common side effects included arthralgia, nausea, and neutropenia, with researchers selecting the optimized dose regimen for the ongoing phase 3 portion of the REFRΑME-O1 trial.
Novel IL-12 Delivery System Shows Promise for Advanced Ovarian Cancer Treatment
• Researchers are developing innovative non-viral delivery systems for IL-12 immunotherapy, targeting the tumor microenvironment while minimizing systemic toxicity in ovarian cancer treatment.
• IMUNON's TheraPlas platform utilizes DNA plasmid vectors in nanoparticles to deliver IL-12 locally to tumors, potentially offering a breakthrough in treating advanced ovarian cancer.
• Despite being a powerful anti-cancer cytokine discovered in 1989, IL-12's therapeutic potential has been limited by systemic side effects, prompting the development of targeted delivery approaches.
BioNTech Advances Oncology Pipeline with BNT327/PM8002 and mRNA Immunotherapies
• BioNTech is progressing BNT327/PM8002, a bispecific antibody, into global clinical trials for first-line small cell lung cancer and non-small cell lung cancer.
• The company plans to initiate additional trials combining BNT327/PM8002 with antibody-drug conjugates (ADCs) in 2025, expanding its combination strategy.
• BioNTech's mRNA cancer immunotherapy, autogene cevumeran, is being evaluated in a Phase 2 trial for muscle-invasive urothelial carcinoma in combination with nivolumab.
• Clinical data readouts are expected in 2025 and 2026 from multiple randomized trials of personalized and off-the-shelf mRNA cancer immunotherapy candidates.
FDA Reviews Accelerated Approvals for Keytruda, Opdivo, and Tecentriq in Multiple Cancers
• The FDA is re-evaluating the accelerated approvals of Merck's Keytruda, Bristol-Myers Squibb's Opdivo, and Roche's Tecentriq across six cancer types due to failed confirmatory trials.
• ODAC will discuss Tecentriq with Abraxane for advanced triple-negative breast cancer, focusing on alternative confirmatory studies after the Impassion131 trial failure.
• Keytruda and Tecentriq's first-line treatment status for urothelial carcinoma is under review, considering the approval of Bavencio as a first-line maintenance therapy.
• The committee will also assess Keytruda for gastric cancer and Keytruda/Opdivo for hepatocellular carcinoma, examining if the initial benefits have been confirmed.
ImmunoGen's ELAHERE Receives Accelerated FDA Approval for Ovarian Cancer Treatment
ImmunoGen, Inc. has achieved accelerated FDA approval for its ovarian cancer drug ELAHERE, targeting patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer. This marks a significant advancement in treatment options for patients with limited alternatives.
Outlook Therapeutics' ONS-5010 Shows Non-Inferiority to Ranibizumab in Wet AMD Trial
• Outlook Therapeutics' ONS-5010 demonstrated non-inferiority to ranibizumab (Lucentis) at week 12 in the NORSE EIGHT trial for wet AMD.
• The company plans to resubmit the Biologics License Application (BLA) for ONS-5010 in the first quarter of calendar 2025 based on the trial results.
• ONS-5010/LYTENAVA has already been granted marketing authorization in the EU and UK, with a commercial launch planned for H1 2025.
• The NORSE EIGHT trial showed a mean 5.5 letter improvement in BCVA in the ONS-5010 arm, compared to a 6.5 letter improvement in the ranibizumab arm.
Keytruda Approved in China for Early-Stage NSCLC Treatment
• Keytruda gains approval in China for resectable stage II, IIIA, or IIIB NSCLC in combination with platinum-containing chemotherapy.
• The approval is based on the KEYNOTE-671 trial, demonstrating a significant improvement in overall survival and event-free survival.
• This marks Keytruda's fourth indication for NSCLC in China, extending its use to earlier stages of the disease.
• The treatment involves neoadjuvant Keytruda plus chemotherapy, followed by adjuvant Keytruda monotherapy post-surgery.
Keytruda/Lenvima Combo Shows Mixed Results in Gastroesophageal Adenocarcinoma Trial
• The Phase 3 LEAP-015 trial evaluated Keytruda plus Lenvima with chemotherapy for HER2-negative gastroesophageal adenocarcinoma.
• The combination significantly improved progression-free survival and objective response rate compared to chemotherapy alone.
• However, the trial failed to meet its other primary endpoint of overall survival in the final analysis.
• The safety profile of the Keytruda plus Lenvima regimen was consistent with prior studies.
Niraparib Shows Promise in Extending Progression-Free Survival in Epithelial Ovarian Cancer
• Niraparib monotherapy extends real-world progression-free survival (rwPFS) and time to next treatment (rwTTNT) in patients with epithelial ovarian cancer (EOC).
• Patients with homologous recombination-deficient (HRd) tumors, particularly those with BRCA-mutated tumors, experienced longer rwPFS and rwTTNT.
• Niraparib demonstrates clinical benefit in stage III EOC patients with no visible residual disease (NVRD) after primary cytoreductive surgery (PCS).
• Niraparib stands out among PARP inhibitors for its broad frontline maintenance therapy approval in EOC, regardless of BRCA mutation or HRD status.
Mirvetuximab Soravtansine Gains Global Approvals for FRα-Positive Platinum-Resistant Ovarian Cancer
• Mirvetuximab soravtansine receives European Commission approval for treating FRα-positive, platinum-resistant ovarian cancer after 1-3 prior systemic treatments.
• The approval was based on the MIRASOL trial, demonstrating a 35% reduction in disease progression or death risk and a 33% reduction in mortality compared to chemotherapy.
• The FDA granted full approval in March 2024, reinforcing mirvetuximab soravtansine's efficacy and superiority over standard care options for advanced ovarian cancer.
• Early FRα testing and specialist management of ocular toxicities are crucial for maximizing the efficacy and maintaining the quality of life for patients on mirvetuximab soravtansine.
US Biosimilar Market Reaches Critical Milestone: Key Learnings from 5 Years of Growth
• The US biosimilar market has evolved significantly since Sandoz's Zarxio launch five years ago, with six major biosimilar launches occurring in recent months and potential cost savings of $54 billion through 2026.
• Physician confidence remains a significant barrier to biosimilar adoption, with 74% of surveyed physicians citing it as a major challenge, highlighting the critical need for enhanced educational initiatives.
• Strategic planning, comprehensive provider education, and continued advocacy efforts have emerged as crucial factors for successful biosimilar market penetration and sustainability.
FDA Approves Ontruzant, Samsung Bioepis and Merck's Biosimilar to Herceptin for Cancer Treatment
• The FDA has granted approval for Ontruzant, a biosimilar version of Roche's Herceptin, developed by Samsung Bioepis and to be marketed by Merck & Co in the United States.
• The biosimilar is approved for multiple indications including HER2-positive breast cancer and metastatic gastric cancer, offering a potentially more affordable treatment option.
• This marks Samsung Bioepis' first FDA-approved oncology biosimilar, joining other competitors like Celltrion/Teva and Mylan in the Herceptin biosimilar market.
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