The Emerging Role of Ofatumumab in the Treatment of Chronic Lymphocytic Leukemia

Nabhan, Chadi; Kay, Neil E.

doi:10.4137/cmo.s4087

Cited by 9 publications

(4 citation statements)

References 75 publications

(127 reference statements)

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“…This was part of the impetus to develop newer anti-CD20 targeted antibodies with a goal to improve such characteristics as binding affinity, specificity and effector function, and efficacy [44]. Ofatumumab (ofa), a fully human monoclonal IgG1 binds to a unique epitope [45], induces considerably higher complement dependent cytotoxicity (CDC) than rituximab [46] and shows activity in rituxan-refractory B cell lymphoma [47].…”

Section: Mabs Approved For Clinical Usementioning

confidence: 99%

Therapeutic Antibodies Against Cancer

Adler¹,

Dimitrov²

2012

Hematology/Oncology Clinics of North America

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Antibody-based therapeutics against cancer are highly successful in clinic and currently enjoy unprecedented recognition of their potential; 13 monoclonal antibodies (mAbs) have been approved for clinical use in the European Union and in the United States (one, mylotarg, was withdrawn from market in 2010). Three of the mAbs (bevacizumab, rituximab, trastuzumab) are in the top six selling protein therapeutics with sales in 2010 of more than $5 bln each. Hundreds of mAbs including bispecific mAbs and multispecific fusion proteins, mAbs conjugated with small molecule drugs and mAbs with optimized pharmacokinetics are in clinical trials. However, challenges remain and it appears that deeper understanding of mechanisms is needed to overcome major problems including resistance to therapy, access to targets, complexity of biological systems and individual variations.

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Section: Mabs Approved For Clinical Usementioning

confidence: 99%

Therapeutic Antibodies Against Cancer

Adler¹,

Dimitrov²

2012

Hematology/Oncology Clinics of North America

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“…Since the introduction of rituximab in 1997, only 2 more "naked" (nonconjugated) antibodies have been approved for the treatment of lymphoma: (i) alemtuzumab, an anti-CD52 antibody approved in 2001 for the treatment of CLL (17); and (ii) ofatumumab, a second-generation anti-CD20 antibody displaying increased complement-dependent cytotoxicity compared with rituximab, that was approved in 2009 for relapse/refractory CLL patients who failed fludarabine and alemtuzumab (18). In addition to these 2 naked antibodies, 2 murine anti-CD20 radionuclide conjugates were approved for consolidation treatment in 2002 ( 90 Y-ibritumomab) and 2003 ( 131 I-tositumomab; refs.…”

Section: Monoclonal Antibodies Beyond Rituximab For Treating B-cell Mmentioning

confidence: 99%

SAR3419: An Anti-CD19-Maytansinoid Immunoconjugate for the Treatment of B-Cell Malignancies

Blanc

Bousseau

Caron

et al. 2011

Clinical Cancer Research

151

119

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SAR3419 is a novel anti-CD19 humanized monoclonal antibody conjugated to a maytansine derivate through a cleavable linker for the treatment of B-cell malignancies. SAR3419 combines the strengths of a high-potency tubulin inhibitor and the exquisite B-cell selectivity of an anti-CD19 antibody. The internalization and processing of SAR3419, following its binding at the surface of CD19-positive human lymphoma cell lines and xenograft models, release active metabolites that trigger cell-cycle arrest and apoptosis, leading to cell death and tumor regression. SAR3419 has also been shown to be active in different lymphoma xenograft models, including aggressive diffuse large B-cell lymphoma, resulting in complete regressions and tumor-free survival. In these models, the activity of SAR3419 compared favorably with rituximab and lymphoma standard of care chemotherapy. Two phase I trials with 2 different schedules of SAR3419 as a single agent were conducted in refractory/relapsed B-cell non-Hodgkin lymphoma. Activity was reported in both schedules, in heavily pretreated patients of both follicular and diffuse large B-cell lymphoma subtypes, with a notable lack of significant hematological toxicity, validating SAR3419 as an effective antibody-drug conjugate and opening opportunities in the future. Numerous B-cell-specific anti-CD19 biologics are available to treat B-cell non-Hodgkin lymphoma, and early phase I results obtained with SAR3419 suggest that it is a promising candidate for further development in this disease. In addition, thanks to the broad expression of CD19, SAR3419 may provide treatment options for B-cell leukemias that are often CD20-negative.

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“…The largest category of biotech drugs consumed in Italy between 2004 and 2011 was anticancer drugs followed by antidiabetics, anti-infectives, drugs used against haematological diseases and hormonal preparations. A great number of monoclonal antibodies are used as anticancer agents in monotherapy or in association with traditional chemotherapy, representing a new therapeutic strategy to improve patient survival and quality of life 27 28. Another remarkable example is represented by the vaccines against human papillomavirus, a valuable tool in cervical cancer prevention.…”

Section: Discussionmentioning

confidence: 99%

The impact of innovation for biotech drugs: an Italian analysis of products licensed in Europe between 2004 and 2011

Andria

Auriemma²,

Attanasio

et al. 2013

Eur J Hosp Pharm

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Objective Biotechnology has promoted the discovery and development of new types of therapeutical agents for use in humans: biotech drugs offer innovative, targeted therapies with enormous potential to address unmet medical needs of patients with cancer, AIDS and other serious diseases. However, the therapeutic application of these novel therapies poses serious problems concerning the connection between cost sustainability and innovative value. The aims of the present study are to assess the level of therapeutic innovation of biotech drugs approved by the European Medicines Agency between 2004 and 2011, to make a comparison with the trend of biotech drugs approved between 1995–2003, as previously reported, and to evaluate their economic impact on the Italian healthcare system. Methods The data source used was the European Public Assessment Report (EPAR) of human medicines available on European Medicines Agency (EMA) website. The scores for therapeutic innovation were assigned according to the algorithm created by Motola et al. Drug expenditure data was obtained from Information Management System–Health Italy database. The list of drugs under analysis was downloaded from European Medicines Agency website and information on approved drugs were retrieved from the European Public Assessment Reports as well as from PubMed databank. Results From 2004 to 2011, the European Medicines Agency approved 47 biotech drugs: 43 biopharmaceutical innovators and 4 vaccines. Our analysis involved 33 of the 47 biotech drugs approved: 18 products resulted in important therapeutic innovations, 6 in moderate and 5 in modest therapeutic innovations, 2 in pharmacological innovations and finally, 2 involved only technological innovations. We also evaluated the influence of biotech drugs and their different scores for innovation with regard to expenditure as well as consumption. In 2010 and in 2011, the major part of expenditure and consumption concerned biotech drugs classified as important therapeutic innovations, while moderate, modest, pharmacological and technological innovators revealed very reduced contributions in this regard. Conclusions Our study revealed that 50% of biotech drugs approved between 2004–2011 represented an important or moderate therapeutic innovation. The remaining biotech drugs did not add any extra value in the decision-making process concerning the application of economic strategies in the healthcare field. These considerations suggest decision-makers should optimise application of health technology assessment strategies aimed at evaluating new technologies and sustainable costs in clinical practice.

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The Emerging Role of Ofatumumab in the Treatment of Chronic Lymphocytic Leukemia

Cited by 9 publications

References 75 publications

Therapeutic Antibodies Against Cancer

Therapeutic Antibodies Against Cancer

SAR3419: An Anti-CD19-Maytansinoid Immunoconjugate for the Treatment of B-Cell Malignancies

The impact of innovation for biotech drugs: an Italian analysis of products licensed in Europe between 2004 and 2011

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