Mvasi (bevacizumab-awwb) / Daiichi Sankyo, Amgen, AbbVie - LARVOL DELTA

Product Sales Performance (PRNewswire) - "LUMAKRAS/LUMYKRAS (sotorasib) sales increased 23% year-over-year to $111 million in the second quarter, primarily driven by volume growth...XGEVA (denosumab) sales decreased 34% year-over-year to $352 million in the second quarter, primarily driven by 22% lower volume and 8% lower net selling price as multiple biosimilars have launched globally with more biosimilars expected; MVASI (bevacizumab-awwb) sales decreased 20% year-over-year to $153 million in the second quarter, driven by 16% lower net selling price and lower volume."

Sales • Cervical Cancer • Colorectal Cancer • Giant Cell Tumor of Bone • Glioblastoma • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Renal Cell Carcinoma

Cost-effectiveness of a bevacizumab biosimilar for the treatment of recurrent, platinum-sensitive ovarian cancer in the United States. (PubMed, Gynecol Oncol) - "Bevacizumab has the potential to be cost-effective in treating recurrent, platinum-sensitive EOC, provided its cost is similar to current, lowest-cost biosimilars."

HEOR • Journal • Platinum sensitive • Epithelial Ovarian Cancer • Oncology • Ovarian Cancer • Solid Tumor

Testing Bound-State Diffusion as a Model for Mucosal Transport of Nanoparticles. (PubMed, ACS Appl Bio Mater) - "Further, we show that particles co-decorated with HA and MVASI, an antibody used in a variety of angiogenic cancer settings, retain both muco-diffusive properties and biological activity of the antibody. Our results demonstrate the feasibility of using bound-state diffusion in nanoparticle design for the delivery of biologics through mucosal barriers."

Journal • Oncology

Are Biosimilars as Safe? A Comparative Study of Bevacizumab in Gynecologic Cancer (WAGO 2026) - "Conclusions Our study suggests real world differences in rates of hypertension, proteinuria and thromboembolic events with bevacizumab and its biosimilars MVASI and ZIRABEV. These findings support the need for ongoing evaluation of biosimilar agents as their use becomes ubiquitous."

Gynecologic Cancers • Oncology

CodeBreaK 301: Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb in Treatment-naïve Participants With Metastatic Colorectal Cancer With KRAS p.G12C Mutation (clinicaltrials.gov) - P3 | N=450 | Recruiting | Sponsor: Amgen | Trial completion date: Aug 2031 ➔ Apr 2032 | Trial primary completion date: Jan 2028 ➔ Sep 2028

Trial completion date • Trial primary completion date • Colorectal Cancer • Oncology • Solid Tumor • KRAS

Product Sales Performance: Oncology (Amgen Press Release) - "LUMAKRAS/LUMYKRAS (sotorasib) sales increased 11% year-over-year to $94 million in the first quarter, driven by volume growth. Nplate (romiplostim) sales increased 32% year-over-year to $412 million in the first quarter. Excluding the U.S. government order of $60 million in the first quarter of 2026, Nplate sales increased 12%, driven by 8% volume growth and higher net selling price. XGEVA (denosumab) sales decreased 27% year-over-year to $411 million in the first quarter, driven by 19% lower volume and lower net selling price. For 2026, we continue to expect accelerated sales erosion driven by increased competition, as multiple biosimilars have launched globally. MVASI (bevacizumab-awwb) sales decreased 16% year-over-year to $150 million in the first quarter, driven by 8% lower net selling price and 7% unfavorable changes to estimated sales deductions."

Sales • Anemia • Colorectal Cancer • Giant Cell Tumor of Bone • Lung Non-Squamous Non-Small Cell Cancer • Multiple Myeloma • Ovarian Cancer • Peritoneal Cancer • Prostate Cancer • Renal Cell Carcinoma • Rheumatoid Arthritis • Solid Tumor • Thoracic Cancer • Thrombocytopenia • Thrombocytopenic Purpura

Amgen...announced financial results for the fourth quarter and full year of 2025 versus the comparable periods in 2024. (PRNewswire) - "Nplate (romiplostim) sales increased 14% year-over-year to $385 million in the fourth quarter...IMDELLTRA (tarlatamab-dlle)/IMDYLLTRA™ (tarlatamab) generated $234 million of sales in the fourth quarter....MVASI (bevacizumab-awwb) sales increased 9% year-over-year to $188 million in the fourth quarter..."

Sales • Cervical Cancer • Epithelial Ovarian Cancer • Fallopian Tube Cancer • Glioblastoma • Immune Thrombocytopenic Purpura • Non Small Cell Lung Cancer • Ovarian Cancer • Peritoneal Cancer • Renal Cell Carcinoma • Small Cell Lung Cancer

Oncology (Amgen Press Release) - "Vectibix (panitumumab) sales increased 1% year-over-year to $284 million in the third quarter; KYPROLIS (carfilzomib) sales decreased 5% year-over-year to $359 million in the third quarter, driven by lower volume; LUMAKRAS /LUMYKRAS (sotorasib) sales decreased 2% year-over-year to $96 million in the third quarter; XGEVA (denosumab) sales were flat year-over-year at $539 million in the third quarter...Nplate (romiplostim) sales were flat year-over-year at $457 million in the third quarter. U.S. government orders were $90 million in Q3'25 compared to $128 million in Q3'24...IMDELLTRA (tarlatamab-dlle)/IMDYLLTRA (tarlatamab) generated $178 million of sales in the third quarter. Sales increased 33% quarter-over-quarter, primarily driven by volume growth; MVASI (bevacizumab-awwb) sales increased 9% year-over-year to $213 million in the third quarter, driven by favorable changes to estimated sales deductions."

Sales • Cervical Cancer • Colorectal Cancer • Glioblastoma • Lung Non-Squamous Non-Small Cell Cancer • Multiple Myeloma • Non Small Cell Lung Cancer • Ovarian Cancer • Renal Cell Carcinoma • Small Cell Lung Cancer

Anti-vascular endothelial growth factor therapies in ophthalmology. (PubMed, Med Hypothesis Discov Innov Ophthalmol) - "Keywords used in the search strategy included terms such as "anti-VEGF therapy", "biosimilar pharmaceuticals", "intravitreal and intrastromal anti-VEGF injections", "retinal diseases" including "macular degeneration" and "retinal neovascularization", "ranibizumab", and "bevacizumab", as well as relevant MeSH terms where applicable...Newer agents such as brolucizumab and faricimab offer prolonged durability and enhanced anatomic outcomes, while biosimilars provide cost-effective alternatives...Anti-VEGF therapies have revolutionized the field of ophthalmology, providing sight-saving treatment for a range of retinal diseases that were once considered untreatable or inevitably blinding. Today, anti-VEGF drugs are the go-to option for managing neovascular retinal disorders, thanks to their proven efficacy, favorable safety profile, and transformative impact on modern eye care."

Journal • Review • Age-related Macular Degeneration • Diabetic Macular Edema • Diabetic Retinopathy • Genetic Disorders • Glaucoma • Hematological Disorders • Inherited Retinal Dystrophy • Macular Degeneration • Ocular Inflammation • Oncology • Ophthalmology • Retinal Disorders • Retinal Vein Occlusion • Retinitis Pigmentosa • Retinopathy of Prematurity • Uveitis • Wet Age-related Macular Degeneration • PRPH

Evolution of Mental Fatigue With Consecutive Match Progression in Elite Fencing. (PubMed, Int J Sports Physiol Perform) - "The present findings regarding intraday MF evolution in elite fencing suggest that practitioners should explore the benefit of proactive countermeasures and recovery strategies from the early rounds of a competition day. Applying real-time monitoring and MF-targeted interventions along with other motivational, emotional adjustments is critical to mitigate MF buildup and maintain performance capacity, particularly when a fencer is successively receiving hits."

Journal • Fatigue

AMGEN REPORTS SECOND QUARTER 2025 FINANCIAL RESULTS (Amgen Press Release) - "XGEVA (denosumab) sales decreased 5% year-over-year to $532 million in the second quarter, driven by 2% unfavorable changes to estimated sales deductions and volume decline. For 2025, we expect sales erosion driven by biosimilar competition in the second half of the year, as biosimilars have now launched in the U.S. market. Nplate (romiplostim) sales increased 7% year-over-year to $369 million in the second quarter, driven by volume growth. IMDELLTRA (tarlatamab-dlle)/IMDYLLTRA (tarlatamab) generated $134 million of sales in the second quarter. Sales increased 65% quarter-over-quarter, driven by volume growth. MVASI (bevacizumab-awwb) sales increased 22% year-over-year to $191 million in the second quarter, driven by 16% favorable changes to estimated sales deductions, 6% volume growth and 5% higher net selling price, partially offset by lower inventory levels."

Sales • Aplastic Anemia • Breast Cancer • Cervical Cancer • Neuroendocrine Tumor • Non Small Cell Lung Cancer • Ovarian Cancer • Prostate Cancer • Renal Cell Carcinoma • Thrombocytopenic Purpura

The Adverse Effects and Use of Bevacizumab in Patients with Glioblastoma: A Systematic Review and Meta-Analysis. (PubMed, Pharmaceuticals (Basel)) - "BV is the active ingredient in the drugs Avastin®, Alymsys®, Mvasi® and ZiraBev®. Finally, the most common adverse effects were nausea, vomiting, fatigue and hypertension. While the beneficial properties of this pharmacological therapy have been observed, its adverse effect profile requires constant evaluation, as it includes vascular, blood and symptomatic adverse effects, which must be analyzed on a case-by-case basis and with great attention, especially in the case of more serious complications such as thromboembolic events."

Adverse events • Clinical • Journal • Retrospective data • Review • Brain Cancer • Cardiovascular • Fatigue • Glioblastoma • Glioma • Hypertension • Oncology • Solid Tumor

Safety of an Intravitreal Bevacizumab Biosimilar (MVASI). (PubMed, Clin Exp Ophthalmol) - "Intravitreal MVASI had a similar ophthalmic safety profile and may be used as an alternative to Avastin."

Journal • Age-related Macular Degeneration • Diabetic Macular Edema • Diabetic Retinopathy • Macular Degeneration • Macular Edema • Ocular Infections • Ocular Inflammation • Oncology • Ophthalmology • Retinal Disorders • Retinal Vein Occlusion • Uveitis • Vasculitis • Wet Age-related Macular Degeneration

Cost-efficiency and expanded access modeling of conversion to biosimilar bevacizumab in metastatic colorectal and non-squamous non-small cell lung cancer in Medicare. (PubMed, J Med Econ) - "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...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...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..."

Journal • Medicare • Reimbursement • US reimbursement • Colorectal Cancer • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Safety Outcomes of Mobile Laminar Airflow Device To Perform Intravitreal Injections: A Three-Year Retrospective Study. (PubMed, J Hosp Infect) - "Using a portable LAF device, such as the Operio mobile, for IVIs in a non-OR setting is a safe and effective alternative to traditional ORs."

Journal • Retrospective data • Anesthesia • Cardiovascular • Glaucoma • Ocular Infections • Ocular Inflammation • Ophthalmology

CodeBreaK 301: Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb in Treatment-naïve Participants With Metastatic Colorectal Cancer With KRAS p.G12C Mutation (clinicaltrials.gov) - P3 | N=450 | Recruiting | Sponsor: Amgen | Trial completion date: Apr 2031 ➔ Aug 2031 | Trial primary completion date: Sep 2027 ➔ Jan 2028

Trial completion date • Trial primary completion date • Colorectal Cancer • Oncology • Solid Tumor

A phase 3 study of first-line sotorasib, panitumumab, and FOLFIRI versus FOLFIRI with or without bevacizumab-awwb for patients with KRAS G12C–mutated metastatic colorectal cancer (CodeBreaK 301). (ASCO-GI 2025) - P1, P3 | "Clinical Trial Registration Number: NCT06252649 Background: CodeBreaK 300 (NCT05198934) evaluated sotorasib, a selective inhibitor that irreversibly binds to the Kirsten rat sarcoma (KRAS) G12C mutant protein, in combination with panitumumab, an anti–epidermal growth factor receptor inhibitor, and showed that 960 mg sotorasib + panitumumab provided a statistically and clinically significant improvement in progression-free survival compared with trifluridine/tipiracil or regorafenib in patients with chemorefractory metastatic colorectal cancer (mCRC) (1). In CodeBreaK 101 (NCT04185883) subprotocol H expansion cohort 2F, the addition of folinic acid, fluorouracil, and irinotecan (FOLFIRI) to this combination in the first-line setting demonstrated a manageable safety profile and promising response rate of 78% in patients with KRAS G12C–mutated mCRC (2)...2. Siena, ESMO 2024."

Clinical • Metastases • P3 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • EGFR • KRAS

AMGEN REPORTS FOURTH QUARTER AND FULL YEAR 2024 FINANCIAL RESULTS (PRNewswire) - "IMDELLTRA (tarlatamab-dlle) generated $67 million of sales in the fourth quarter. Sales increased 86% quarter-over-quarter, driven by volume growth and inventory levels...MVASI (bevacizumab-awwb) sales decreased 8% year-over-year to $173 million in the fourth quarter and 9% for the full year."

Sales • Cervical Cancer • Colorectal Cancer • Fallopian Tube Cancer • Glioblastoma • Non Small Cell Lung Cancer • Ovarian Cancer • Peritoneal Cancer • Renal Cell Carcinoma • Small Cell Lung Cancer

Systemic anti-VEGF biosimilar therapy associated with improved macular anatomy and duration of effect in a patient with nearly recalcitrant neovascular age-related macular degeneration. (PubMed, Retin Cases Brief Rep) - "When systemic anti-VEGF biosimilar therapy was administered, there was improved anatomy and prolonged duration of effect compared to the intravitreal therapy alone. Adverse systemic effects limit the routine use of systemic anti-VEGF therapy for retinal disease. However if a patient requires systemic anti-VEGF or anti-VEGF biosimilar therapy for malignancy, it may also benefit retinal disease leading to benefits in quality of life and fewer office visits."

Journal • Age-related Macular Degeneration • Macular Degeneration • Oncology • Ophthalmology • Ovarian Cancer • Retinal Disorders • Solid Tumor • Wet Age-related Macular Degeneration

Drugs for age-related macular degeneration. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders

Comparison of Efficacy, Safety, and Economic Outcomes Between Biosimilar ABP 215 and Originator Bevacizumab in Japanese Patients With Colorectal Cancer. (PubMed, Cureus) - "Economic outcomes indicated a potential savings of approximately 800,000 Japanese yen per patient with biosimilar ABP 215 use. Conclusions Although this is a single-center, retrospective, observational study with limitations in terms of the number of cases and background factors, the use of the bevacizumab biosimilar ABP 215 product is recommended in Japan from the perspective of reducing medical costs, given the findings of no differences in efficacy and safety."

HEOR • Journal • Colorectal Cancer • Oncology • Solid Tumor

AMGEN REPORTS THIRD QUARTER 2024 FINANCIAL RESULTS (PRNewswire) - "Nplate (romiplostim) sales increased 9% year-over-year to $456 million in the third quarter. U.S. government orders were $128 million in Q3'24 compared to $142 million in Q3'23. Excluding these U.S. government orders, Nplate sales grew 18% year-over-year in the third quarter, driven by 14% volume growth and higher net selling price; IMDELLTRA (tarlatamab-dlle) generated $36 million of sales in the third quarter. Sales increased 200% quarter-over-quarter, driven by volume growth. IMDELLTRA is the first and only FDA-approved bispecific T-cell engager (BiTE) therapy for the treatment of extensive-stage small cell lung cancer (ES-SCLC); MVASI (bevacizumab-awwb) sales decreased 8% year-over-year to $195 million in the third quarter. Going forward, we expect continued sales erosion driven by competition."

Sales • Brain Cancer • Cervical Cancer • Gynecologic Cancers • Kidney Cancer • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

CodeBreaK 301: Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb in Treatment-naïve Participants With Metastatic Colorectal Cancer With KRAS p.G12C Mutation (clinicaltrials.gov) - P3 | N=450 | Recruiting | Sponsor: Amgen | Trial completion date: Jan 2031 ➔ Apr 2031 | Trial primary completion date: Jun 2027 ➔ Sep 2027

Metastases • Trial completion date • Trial primary completion date • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Combination Chemotherapy, Bevacizumab, and/or Atezolizumab in Treating Patients With Deficient DNA Mismatch Repair Metastatic Colorectal Cancer, the COMMIT Study (clinicaltrials.gov) - P3; N=347; Recruiting; Sponsor: National Cancer Institute (NCI); Not yet recruiting ➔ Recruiting; N=439 ➔ 347

Clinical • Enrollment change • Enrollment open • IO biomarker • Mismatch repair • Monotherapy • Colon Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Microsatellite Instability • Oncology • Solid Tumor • BRAF • MLH1 • MSH2 • MSH6 • MSI • PCR

Combination Chemotherapy, Bevacizumab, and/or Atezolizumab in Treating Patients With Deficient DNA Mismatch Repair Metastatic Colorectal Cancer, the COMMIT Study (clinicaltrials.gov) - P3; N=200; Recruiting; Sponsor: National Cancer Institute (NCI); N=347 ➔ 200

Clinical • Enrollment change • IO biomarker • Mismatch repair • Colon Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Microsatellite Instability • Oncology • Solid Tumor • BRAF • MLH1 • MSH2 • MSH6 • MSI • PCR