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

16:32 EST 12th December 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+

A randomized, single-blind, single-dose study to assess the pharmacokinetic equivalence of the biosimilar ABP 215 and bevacizumab in healthy Japanese male subjects.

Analytic, pharmacokinetic (PK), and clinical similarity between the biosimilar ABP 215 and bevacizumab has previously been demonstrated in global studies. Here we present a phase 1 study in healthy adult Japanese men.


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...

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...

Laparoscopic repair of bevacizumab-induced vesicovaginal fistula in metastatic colon cancer - a video vignette.

Bevacizumab is a humanized monoclonal antibody targeting vascular endothelial growth factor (VEGF). Adding bevacizumab to a variety of first-line regimens used for metastatic colon cancer improves outcomes. Vesicovaginal fistula (VVF) is an extremely rare complication of bevacizumab, which has been reported in a few patients with metastatic cervical cancer. Here, we report a patient with metastatic colon cancer who developed VVF after bevacizumab treatment and which was successfully repaired using a laparo...

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.

Evaluation of Infliximab and Anti-infliximab LISA-TRACKER Immunoassays for the Therapeutic Drug Monitoring of SB2 Infliximab Biosimilar.

SB2, an infliximab (IFX) biosimilar to the reference infliximab (R.I.) product (Remicade), received approval in the European Union for all IFX indications. Many decision algorithms based on the measurement of IFX trough levels and antibodies to infliximab are being increasingly used to optimize IFX treatment. The aim of our study was to evaluate whether the biosimilar SB2 could be efficiently monitored using the LISA-TRACKER IFX and anti-IFX assays developed by Theradiag (Croissy Beaubourg, France).

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...

Bevacizumab in age-related macular degeneration: a randomized controlled trial on the effect of on-demand therapy every 4 or 8 weeks.

Intravitreal anti-vascular endothelial growth factor (VEGF) injections are an effective treatment for neovascular age-related macular degeneration (nARMD). Bevacizumab appears to be a cost-effective off-label anti-VEGF alternative to ranibizumab, but an optimal injection schedule has not yet been determined. In this study, we investigate whether on-demand bevacizumab treatment every 8 weeks is non-inferior to on-demand bevacizumab every 4 weeks in treating nARMD.

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...

Biosimilar Agents for Psoriasis Treatment: The Perspective of Portuguese Patients.

Biosimilars are highly similar copies of previously approved original biologic medicines. Their introduction on the market may yield cost reduction. The aim of this study was to evaluate the perspectives of psoriasis patients on biosimilar medications.

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.

Bevacizumab and Glioblastoma: Past, Present, and Future Directions.

Glioblastoma (GBM) is the most common and lethal intracranial malignancy, with few advances in treatment over the last several decades. Much excitement surrounded the initial approval for bevacizumab for recurrent GBM, given the marked radiographic responses and improvement in progression-free survival observed in early studies. However, phase III studies have failed to demonstrate an overall survival advantage with the use of this agent. An overview of the mechanism of action and activity of bevacizumab in...

Atezolizumab for First-Line Treatment of Metastatic Nonsquamous NSCLC.

Background The cancer-cell-killing property of atezolizumab may be enhanced by the blockade of vascular endothelial growth factor-mediated immunosuppression with bevacizumab. This open-label, phase 3 study evaluated atezolizumab plus bevacizumab plus chemotherapy in patients with metastatic nonsquamous non-small-cell lung cancer (NSCLC) who had not previously received chemotherapy. Methods We randomly assigned patients to receive atezolizumab plus carboplatin plus paclitaxel (ACP), bevacizumab plus carbopla...

Bevacizumab Monotherapy Reduces Radiation-induced Brain Necrosis in Nasopharyngeal Carcinoma Patients: A Randomized Controlled Trial.

Studies have shown that addition of bevacizumab to corticosteroids improves outcome against radiation-induced brain necrosis (RN). Here, we aimed to evaluate the effectiveness and safety of bevacizumab monotherapy on RN in nasopharyngeal carcinoma (NPC) patients.

Nanoparticles provide long-term stability of bevacizumab preserving its antiangiogenic activity.

Bevacizumab is one of the most common monoclonal antibodies used to treat cancer due to its antiangiogenic role. However, the frequent parenteral administrations are not attractive for the patient adhesion to the therapy. Nanoencapsulation of bevacizumab might be a useful alternative to increase administration intervals, due to controlled release properties. To achieve a long-term bevacizumab stability into PLGA nanoparticles, we developed an optimized and validated lyophilization protocol. The co-encapsula...

Adjuvant bevacizumab for melanoma patients at high risk of recurrence: survival analysis of the AVAST-M trial.

Bevacizumab is a recombinant humanised monoclonal antibody to vascular endothelial growth factor (VEGF) shown to improve survival in advanced solid cancers. We evaluated the role of adjuvant bevacizumab in melanoma patients at high risk of recurrence.

Safety and efficacy of neoadjuvant chemotherapy with bevacizumab in advanced-stage peritoneal/ovarian cancer patients.

The aim of this study was to evaluate the outcomes of neoadjuvant chemotherapy (NAC) with bevacizumab (Bev) at our institute.

Comparative safety assessments of the biosimilar APZ001 and Erbitux in pre-clinical animal models.

To evaluate the toxicity of Erbitux as well as its biosimilar APZ001 antibody (APZ001) in pre-clinical animal models including mice, rabbits and cynomolgus monkeys.

Dynamic Angiogenic Switch as Predictor of Response to Chemotherapy-Bevacizumab in Patients With Metastatic Colorectal Cancer.

Previous studies have shown that metastatic colorectal carcinoma (mCRC) patients treated with bevacizumab, experience variation in the plasma levels of angiogenesis growth factors and related cytokines, called angiogenic switch (AS). The aim of the present study was to analyze the relationship between AS and the clinical response during standard chemotherapy-bevacizumab treatment.

Switch maintenance therapy with docetaxel and bevacizumab after induction therapy with cisplatin, pemetrexed, and bevacizumab in advanced non-squamous non-small cell lung cancer: a phase II study.

Switch maintenance therapy, using alternative agents that were not administered during induction chemotherapy, is a treatment option for advanced non-squamous non-small cell lung cancer (NSCLC). Bevacizumab is known to increase the efficacy of other chemotherapeutic agents; however, switch maintenance therapy with docetaxel and bevacizumab has not been adequately studied. The goal of this study was to evaluate the efficacy and safety of switch maintenance therapy with docetaxel and bevacizumab following ind...


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