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PubMed Journals Articles About "Amgen Allergan Receive Positive CHMP Opinion Biosimilar Bevacizumab" RSS

09:12 EDT 25th September 2018 | BioPortfolio

Amgen Allergan Receive Positive CHMP Opinion Biosimilar Bevacizumab PubMed articles on BioPortfolio. Our PubMed references draw on over 21 million records from the medical literature. Here you can see the latest Amgen Allergan Receive Positive CHMP Opinion Biosimilar Bevacizumab articles that have been published worldwide.

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Showing "Amgen Allergan Receive Positive CHMP Opinion Biosimilar Bevacizumab" PubMed Articles 1–25 of 11,000+

Sandoz receives positive CHMP opinion for proposed biosimilar infliximab.


Analytical and functional similarity of Amgen biosimilar ABP 215 to bevacizumab.

ABP 215 is a biosimilar product to bevacizumab. Bevacizumab acts by binding to vascular endothelial growth factor A, inhibiting endothelial cell proliferation and new blood vessel formation, thereby leading to tumor vasculature normalization. The ABP 215 analytical similarity assessment was designed to assess the structural and functional similarity of ABP 215 and bevacizumab sourced from both the United States (US) and the European Union (EU). Similarity assessment was also made between the US- and EU-sour...

Biosimilar medicines used for cancer therapy in Europe: a review.

This article provides an updated review of the biosimilar medicines approved for cancer therapy in the European Union (EU). First we discuss the most relevant aspects for the development and approval of biosimilar medicines. We then present the oncological biosimilar drugs currently used, which include epoetins (alpha and zeta), filgrastim, and monoclonal antibodies (rituximab, trastuzumab and bevacizumab). Among the clinical applications of biosimilar medicines, cancer therapy remains the main target area ...


Double-Blind Phase III Trial of Adjuvant Chemotherapy With and Without Bevacizumab in Patients With Lymph Node-Positive and High-Risk Lymph Node-Negative Breast Cancer (E5103).

Purpose Bevacizumab improves progression-free survival but not overall survival in patients with metastatic breast cancer. E5103 tested the effect of bevacizumab in the adjuvant setting in patients with human epidermal growth factor receptor 2-negative disease. Patients and Methods Patients were assigned 1:2:2 to receive placebo with doxorubicin and cyclophosphamide (AC) followed by weekly paclitaxel (arm A), bevacizumab only during AC and paclitaxel (arm B), or bevacizumab during AC and paclitaxel followed...

Loss of Chromosome 18q11.2-q12.1 Is Predictive for Survival in Patients With Metastatic Colorectal Cancer Treated With Bevacizumab.

Purpose Patients with metastatic colorectal cancer (mCRC) have limited benefit from the addition of bevacizumab to standard chemotherapy. However, a subset probably benefits substantially, highlighting an unmet clinical need for a biomarker of response to bevacizumab. Previously, we demonstrated that losses of chromosomes 5q34, 17q12, and 18q11.2-q12.1 had a significant correlation with progression-free survival (PFS) in patients with mCRC treated with bevacizumab in the CAIRO2 clinical trial but not in pat...

Letter--Incorporating Real-World Evidence and Patient Value Criteria into Value-Based Frameworks for Relapsed/Refractory Multiple Myeloma.

Orlowski has received research funding from Amgen, BioTheryX, Bristol-Myers Squibb, Celgene Corporation, and Takeda Pharmaceuticals; honoraria from Amgen, Bristol-Myers Squibb, Celgene Corporation, Janssen, Millennium Pharmaceuticals, and Onyx Pharmaceuticals; and is a member of advisory boards for Amgen, Bristol-Myers Squibb, Celgene Corporation, Incyte, Kite, Legend Biotech, Sanofi-Aventis, and Takeda Pharmaceuticals.

Switching to a infliximab biosimilar: short-term results of clinical monitoring in patients with inflammatory bowel disease.

Currently, a biosimilar of Remicade is available (CT-P13). Switching patients from Remicade to a biosimilar is still under debate, especially for patients with inflammatory bowel disease (IBD). In a retrospective study, we investigated the feasibility and safety of switching patients with IBD from Remicade to a biosimilar infliximab.

The Global Need for a Trastuzumab Biosimilar for Patients With HER2-Positive Breast Cancer.

Trastuzumab improves survival outcomes for patients with HER2-positive (HER2) breast cancer, yet not all such women receive this important therapy. Trastuzumab was approved by the US Food and Drug Administration in 1998 and the European Medicines Agency in 2000 as treatment for HER2metastatic breast cancer (MBC). Observational studies between 2000 and 2015 in patients with HER2MBC suggest that nearly 12% in the United States, 27% to 54% in Europe, and 27.1% to 49.2% in China did not receive trastuzumab or a...

Germline genome-wide association studies in women receiving neoadjuvant chemotherapy with or without bevacizumab.

Neoadjuvant chemotherapy (NAC) for breast cancer is widely utilized, and we performed genome-wide association studies (GWAS) to determine whether germ-line genetic variability was associated with benefit in terms of pathological complete response (pCR), disease-free survival, and overall survival in patients entered on the NSABP B-40 NAC trial, wherein patients were randomized to receive, or not, bevacizumab in addition to chemotherapy. Patient DNA samples were genotyped with the Illumina OmniExpress BeadCh...

Ertugliflozin: First Global Approval.

Ertugliflozin (Steglatro™) is an orally active sodium glucose co-transporter type 2 inhibitor being developed by Merck and Pfizer as a treatment for type 2 diabetes mellitus (T2DM). Ertugliflozin as monotherapy and in combination with various other antidiabetic drugs was associated with improvements in glycaemic control and secondary outcome measures in the VERTIS phase III clinical trial program. Ertugliflozin and fixed-dose combinations of ertugliflozin and metformin (Segluromet™) and ertugliflozin an...

Bevacizumab Reduces S100A9 MDSC Linked to Intracranial Control in Patients with EGFR Mutant Lung Adenocarcinoma.

In vitro models have demonstrated immune-modulating effects of bevacizumab. Combinations of EGFR tyrosine kinase inhibitor (TKI) with bevacizumab improve progression free survival (PFS) in patients with EGFR mutated lung adenocarcinoma. How bevacizumab confers this clinical effect and underlying mechanisms are not clear.

Human serum albumin nanoparticles for ocular delivery of bevacizumab.

Bevacizumab-loaded nanoparticles (B-NP) were prepared by a desolvation process followed by freeze-drying, without any chemical, physical or enzymatic cross-linkage. Compared with typical HSA nanoparticles cross-linked with glutaraldehyde (B-NP-GLU), B-NP displayed a significantly higher mean size (310 nm vs. 180 nm) and a lower negative zeta potential (-15 mV vs. -36 mV). On the contrary, B-NP displayed a high payload of approximately 13% when measured by a specific ELISA, whereas B-NP-GLU presented a very ...

Bevacizumab rechallenge in glioblastoma patients with initial response to bevacizumab who later progress off therapy.

The Safety of Bevacizumab Administered Shortly after Laser Interstitial Thermal Therapy in Glioblastoma: A Case Series.

Laser interstitial thermal therapy (LITT) enables ablation of lesions using thermal energy with minimal damage to surrounding regions. Bevacizumab has been used as an adjuvant therapy in recurrent glioblastoma (GBM). Presently, administration of Bevacizumab occurs at least 4-6 weeks after surgical intervention. However, given the minimally invasive nature of LITT, we suggest that Bevacizumab can be safely used in combination with LITT at a shorter interval.

A phase III study comparing SB3 (a proposed trastuzumab biosimilar) and trastuzumab reference product in HER2-positive early breast cancer treated with neoadjuvant-adjuvant treatment: Final safety, immunogenicity and survival results.

The equivalent efficacy between SB3, a proposed trastuzumab biosimilar, and the trastuzumab reference product (TRZ) in terms of the breast pathologic complete response rate after neoadjuvant therapy in patients with early or locally advanced human epidermal growth factor receptor 2-positive breast cancer was demonstrated in the previous report. Here, we report the final safety, immunogenicity and survival results after neoadjuvant-adjuvant treatment.

Efficacy and safety of biosimilar insulins compared to their reference products: A systematic review.

For nearly a century, no generic form of insulin has been available in the United States. However, the first biosimilar insulin, Basaglar, was approved by the U.S. Food and Drug Administration in 2015, and subsequently Admelog and Lusduna in 2017.

Great efficacy of bevacizumab plus erlotinib for leptomeningeal metastases from non-small cell lung cancer with initially positive EGFR mutation: a case report.

Leptomeningeal metastases (LMs) were devastating metastatic complications of non-small cell lung cancer (NSCLC). Management of LMs relied on conventional therapy but with poor survival, lacking effective treatment strategies. We present the case of a 52-year-old female non-smoker with advanced lung adenocarcinoma and initially positive EGFR-mutation, who failed to the treatment of standard first-line chemotherapy (pemetrexed plus cisplatin) and bevacizumab (BEV), and maintenance therapy with pemetrexed plus...

Randomized phase 2 trial of pemetrexed, pemetrexed/bevacizumab, and pemetrexed/carboplatin/bevacizumab in patients with stage IIIB/IV non-small cell lung cancer and an Eastern Cooperative Oncology Group performance status of 2.

The best treatment for patients with advanced non-small cell lung cancer (NSCLC) and a poor performance status is not well defined. In this phase 2 trial, patients were randomized to receive treatment with either single-agent pemetrexed or 1 of 2 combination regimens.

The cost-effectiveness of bevacizumab, ranibizumab and aflibercept for the treatment of age-related macular degeneration-A cost-effectiveness analysis from a societal perspective.

The discussion on the use of bevacizumab is still ongoing and often doctors are deterred from using bevacizumab due to legal or political issues. Bevacizumab is an effective, safe and inexpensive treatment option for neovascular age-related macular degeneration (AMD), albeit unregistered for the disease. Therefore, in some countries ophthalmologists use the equally effective but expensive drugs ranibizumab and aflibercept. We describe the economic consequences of this dilemma surrounding AMD treatment from ...

Bevacizumab in Cervical Cancer: 5 Years After.

Over the past 5 years, addition of bevacizumab to combination chemotherapy for advanced, recurrent, and persistent cervical cancer has offered prolonged overall and progression-free survival. Since the original press release announcing the survival benefits of this antiangiogenesis therapy, there has been further study of bevacizumab related to quality of life, combination with other agents, use of imaging to evaluate likelihood of response, and development of biosimilars. This review summarizes publication...

Bevacizumab may improve quality of life, but not overall survival in glioblastoma: an epidemiological study.

The vascular endothelial growth factor antibody bevacizumab (Avastin®), received approval for the treatment of recurrent glioblastoma in many countries including the US and Switzerland, but not the European Union, in 2009. Here we explored the hypothesis that the approval of bevacizumab improved outcome with glioblastoma on a population level.

Estimating Medicare and patient savings from the use of bevacizumab for the treatment of exudative age-related macular degeneration.

The Medicare cost savings from the use of bevacizumab in the United States for the treatment of exudative age-related macular degeneration (AMD) were estimated by replacing the use of bevacizumab with ranibizumab and aflibercept.

Biosimilar switching and related medical liability.

Unlike generics, biosimilars are similar, but not equivalent, to the reference biological medicinal product. Therefore, if a patient experiences an adverse event, or a loss of efficacy, when transitioned to a biosimilar, the distribution of medical liability will be different from the case of both the originator and generics. Moreover, the case of naïve patients is different from that of non-naïve patients. In the case of naïve patients, physicians make their choice from a range of medicinal products tha...

Cumulative dose of bevacizumab associates with albuminuria rather than podocyturia in cancer patients.

Angiogenesis inhibition with bevacizumab, a monoclonal antibody against vascular endothelial growth factor A (VEGF-A), is an anticancer treatment associated with hypertension and renal glomerular toxicity referred to as a preeclampsia-like syndrome. In preeclampsia, podocyturia predates proteinuria and clinical features of preeclampsia, and is regarded as a biomarker of ongoing glomerular injury. Using a quantitative polymerase chain reaction of the podocyte-specific molecules nephrin, podocin, and VEGF-A i...

Real world study of regimen containing bevacizumab as first-line therapy in Chinese patients with advanced non-small cell lung cancer.

Large scale randomized controlled trials have demonstrated that the use of bevacizumab in addition to chemotherapy in patients with advanced non-small cell lung cancer (NSCLC) conveys significant survival benefits. We explored the clinical impact of a first-line regimen containing bevacizumab (B+) versus a non-bevacizumab regimen (non-B) in advanced non-squamous NSCLC (NS-NSCLC) patients in a real world setting.


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