Trends in the approval of cancer therapies by the FDA in the twenty-first century

Scott, Emma C.; Baines, Andrea; Gong, Yutao; Moore, Rodney V.; Pamuk, Gülsüm Emel; Saber, Haleh; Subedee, Ashim; Thompson, Matthew D.; Xiao, Wenming; Pazdur, Richard; Rao, V. Ashutosh; Schneider, Julie A.; Beaver, Julia A.

doi:10.1038/s41573-023-00723-4

Cited by 84 publications

(37 citation statements)

References 37 publications

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“…Most drugs nowadays are orthosteric drugs. 1,2 Orthosteric agonists promote protein functions while orthosteric antagonists inhibit protein function, both by replacing the natural ligand in the orthosteric (active) site. Such direct binding mode is usually very effective.…”

Section: Introductionmentioning

confidence: 99%

Designing drugs and chemical probes with the dualsteric approach

Zha,

He,

et al. 2023

Chem. Soc. Rev.

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Section: Introductionmentioning

confidence: 99%

Designing drugs and chemical probes with the dualsteric approach

Zha,

He,

et al. 2023

Chem. Soc. Rev.

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“…Advanced Therapeutic Medicinal Products (ATMPs) provide innovative approaches for designing solutions for diagnosing and combating complex diseases 1,2 . Promising breakthroughs in cutting-edge technologies, such as chimeric antigen receptor (CAR)-T cells [3][4][5] and mRNA vaccines [6][7][8][9] , illustrate the potential of such unconventional thinking.…”

Section: Introductionmentioning

confidence: 99%

Rapid and high yield isolation of extracellular vesicles with purity by application of size exclusion fast performance liquid chromatography

Kapoor,

Harris,

Arian

et al. 2023

Preprint

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Extracellular Vesicles (EVs) have emerged as potential biomarkers for diagnosing a range of diseases without invasive procedures. Extracellular vesicles also offer an advantage compared to synthetic vesicles, for delivery of various drugs. However, limitations in segregating EVs from soluble proteins have led to inconsistent EV retrieval rates with low levels of purity. Here, we report a new high-yield (>95%) and rapid (<20 min) EV isolation method called Size Exclusion Fast Performance Liquid Chromatography (SE FPLC). We show SE FPLC can effectively isolate EVs from multiple sources including EVs derived from human and mouse cells and serum. The results indicate that SE FPLC can successfully remove highly abundant protein contaminants such as albumin and lipoprotein complexes, which can represent a major hurdle in large scale isolation of EVs for clinical translation. Additionally, the high-yield nature of SE FPLC allows for easy industrial upscaling of extracellular vesicles production for various clinical utilities. Moreover, SE FPLC enables analysis of very small volumes of blood for use in point-of-care diagnostics in the clinic. Collectively, SE FPLC offers many advantages over current EV isolation methods and offers rapid clinical utility potential.

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“…For example, cell therapy has emerged as a novel cancer treatment approach, with 12 approvals of chimeric antigen receptor (CAR)-T cell therapies since 2017, including 4 in 2022. 3 Likewise, the number of new antibody-drug conjugates reaching the clinical trial stage increased by nearly 5-fold in the last 5 years, with 21 currently in latestage development. 4 Whereas there were only a handful of new bispecific antibody (bsAb) clinical candidates per year in the first decade of this century, recent years have seen a remarkable growth for this modality class, with more than 50 bsAbs reaching clinical trials in 2021.…”

mentioning

confidence: 99%

Novel Therapeutic Modalities: The Future is Now

Choi,

Vinks,

van der Graaf

2023

Clin Pharma and Therapeutics

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Trends in the approval of cancer therapies by the FDA in the twenty-first century

Cited by 84 publications

References 37 publications

Designing drugs and chemical probes with the dualsteric approach

Designing drugs and chemical probes with the dualsteric approach

Rapid and high yield isolation of extracellular vesicles with purity by application of size exclusion fast performance liquid chromatography

Novel Therapeutic Modalities: The Future is Now

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