Trastuzumab (Herceptin®) and Ado‐Trastuzumab Emtansine (Kadcyla®): Treatments for HER2‐Positive Breast Cancer

Chowdhury, R; Ellis, Paul

doi:10.1002/9783527682423.ch72

Cited by 2 publications

(2 citation statements)

References 68 publications

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“…62 This same targeting method is used in another 94,95 and the more recently approved antibody drug conjugate version (Kadcyla). 96,97 Other systems use bi-specific antibodies to target delivery of mRNA therapeutics (TargomiRs).…”

Section: Targeted Delivery Systemsmentioning

confidence: 99%

“…A HER‐2 targeted PEGylated liposomal doxorubicin (MM‐302) for treatment of breast cancer is also being developed . This builds on the success of FDA‐approved and HER‐2 targeted monoclonal antibody Herceptin (trastuzumab) and the more recently approved antibody drug conjugate version (Kadcyla) . Other systems use bi‐specific antibodies to target delivery of mRNA therapeutics (TargomiRs).…”

Section: Current Nanoparticle/microparticle Clinical Trialsmentioning

confidence: 99%

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Nanoparticles in the clinic

Anselmo

Mitragotri

2016

Bioengineering & Transla Med

1,044

603

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Nanoparticle/microparticle‐based drug delivery systems for systemic (i.e., intravenous) applications have significant advantages over their nonformulated and free drug counterparts. For example, nanoparticle systems are capable of delivering therapeutics and treating areas of the body that other delivery systems cannot reach. As such, nanoparticle drug delivery and imaging systems are one of the most investigated systems in preclinical and clinical settings. Here, we will highlight the diversity of nanoparticle types, the key advantages these systems have over their free drug counterparts, and discuss their overall potential in influencing clinical care. In particular, we will focus on current clinical trials for nanoparticle formulations that have yet to be clinically approved. Additional emphasis will be on clinically approved nanoparticle systems, both for their currently approved indications and their use in active clinical trials. Finally, we will discuss many of the often overlooked biological, technological, and study design challenges that impact the clinical success of nanoparticle delivery systems.

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Section: Targeted Delivery Systemsmentioning

confidence: 99%

Section: Current Nanoparticle/microparticle Clinical Trialsmentioning

confidence: 99%

Nanoparticles in the clinic

Anselmo

Mitragotri

2016

Bioengineering & Transla Med

1,044

603

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Next Generation Biopharmaceuticals: Product Development

Mathaes

Mahler

2018

New Bioprocessing Strategies: Development and Manufacturing of Recombinant Antibodies and Proteins

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Therapeutic proteins show a rapid market growth. The relatively young biotech industry already represents 20 % of the total global pharma market. The biotech industry environment has traditionally been fast-pasted and intellectually stimulated. Nowadays the top ten best selling drugs are dominated by monoclonal antibodies (mABs).Despite mABs being the biggest medical breakthrough in the last 25 years, technical innovation does not stand still.The goal remains to preserve the benefits of a conventional mAB (serum half-life and specificity) whilst further improving efficacy and safety and to open new and better avenues for treating patients, e.g., improving the potency of molecules, target binding, tissue penetration, tailored pharmacokinetics, and reduced adverse effects or immunogenicity.The next generation of biopharmaceuticals can pose specific chemistry, manufacturing, and control (CMC) challenges. In contrast to conventional proteins, next-generation biopharmaceuticals often require lyophilization of the final drug product to ensure storage stability over shelf-life time. In addition, next-generation biopharmaceuticals require analytical methods that cover different ways of possible degradation patterns and pathways, and product development is a long way from being straight forward. The element of "prior knowledge" does not exist equally for most novel formats compared to antibodies, and thus the assessment of critical quality attributes (CQAs) and the definition of CQA assessment criteria and specifications is difficult, especially in early-stage development.

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Trastuzumab (Herceptin®) and Ado‐Trastuzumab Emtansine (Kadcyla®): Treatments for HER2‐Positive Breast Cancer

Cited by 2 publications

References 68 publications

Nanoparticles in the clinic

Nanoparticles in the clinic

Next Generation Biopharmaceuticals: Product Development

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