Highlights of FDA Oncology Approvals in 2022: Tissue-Agnostic Indications, Dosage Optimization, and Diversity in Drug Development

Duke, Elizabeth S.; Fusco, Michael; DeMoss, Patrick; Dilawari, Asma; Pamuk, Gulsum E; Boehmer, Jessica; Mixter, Bronwyn D.; Goldberg, Kirsten B.; Kluetz, Paul G.; Pazdur, Richard

doi:10.1158/2159-8290.cd-22-1185

Cited by 5 publications

(2 citation statements)

References 4 publications

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“…[ 123 ] Antibodies and antibody fragments have gained widespread recognition for their ability to attach specific overexpressed receptors on cancer cells. [ 124 ] Consequently, researchers have devoted significant time and effort to developing targeting strategies using antibody‐functionalized NPs. These therapeutic systems hold great potential for enhancing therapeutic efficacy and minimizing adverse effects.…”

Section: Polymeric Nanoparticle Fabrication Strategiesmentioning

confidence: 99%

Trastuzumab‐based nanomedicines for breast cancer therapy: Recent advances and future opportunities

Selepe,

Dhlamini,

Tshweu

et al. 2024

Nano Select

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According to the World Health Organization (WHO), there are more than 2.3 million cases of breast cancer (BC) each year, with 80% of deaths occurring in low‐ and middle‐income countries (LMICs). Chemotherapeutic agents are used in the treatment of BC to kill or slow the growth of cancer cells. While they can be effective in many cases, they also have potential side effects. These include long‐term effects such as possible damage to healthy organs, limited efficacy, and resistance development. Trastuzumab (Tmab) offers superior treatment options due to low toxicity and high specificity for a target antigen. However, Tmab treatment, despite being available for the last two decades, has remained challenging and expensive to manage, and inaccessible to people in underserved communities. Therefore, it is necessary to ensure that such effective medication is within reach of those in need, regardless of social or economic class. Recent advances in nanomedicine have led to a growing number of studies that show promise in meeting these challenges through access to adequate anticancer drugs in LMICs. This review analyzes such reports while highlighting the progress of nanomedicine and anticancer drug systems and presents opportunities that have been overlooked over the years for LMICs.

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Section: Polymeric Nanoparticle Fabrication Strategiesmentioning

confidence: 99%

Trastuzumab‐based nanomedicines for breast cancer therapy: Recent advances and future opportunities

Selepe,

Dhlamini,

Tshweu

et al. 2024

Nano Select

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show abstract

“…The pivotal studies leading to these landmark approvals were remarkable for their clear demonstration of efficacy regardless of tumor type. Several additional tumor-agnostic approvals for advanced solid tumors have followed ( Duke et al 2022 , Gouda et al 2023 , Lavacchi et al 2020 , Moore & Guinigundo 2023 , Tateo et al 2023 ) ( Figure 1 ).…”

Section: Introductionmentioning

confidence: 99%

Basket Trials: Past, Present, and Future

Murciano-Goroff,

Uppal,

Chen

et al. 2024

Annual Review of Cancer Biology

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Large-scale tumor molecular profiling has revealed that diverse cancer histologies are driven by common pathways with unifying biomarkers that can be exploited therapeutically. Disease-agnostic basket trials have been increasingly utilized to test biomarker-driven therapies across cancer types. These trials have led to drug approvals and improved the lives of patients while simultaneously advancing our understanding of cancer biology. This review focuses on the practicalities of implementing basket trials, with an emphasis on molecularly targeted trials. We examine the biologic subtleties of genomic biomarker and patient selection, discuss previous successes in drug development facilitated by basket trials, describe certain novel targets and drugs, and emphasize practical considerations for participant recruitment and study design. This review also highlights strategies for aiding patient access to basket trials. As basket trials become more common, steps to ensure equitable implementation of these studies will be critical for molecularly targeted drug development. Expected final online publication date for the Annual Review of Cancer Biology, Volume 8 is April 2024. Please see http://www.annualreviews.org/page/journal/pubdates for revised estimates.

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Drug development for major chronic health conditions—aligning with growing public health needs: Proceedings from a multistakeholder think tank

Krychtiuk,

Andersson,

Bodesheim

et al. 2024

American Heart Journal

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Highlights of FDA Oncology Approvals in 2022: Tissue-Agnostic Indications, Dosage Optimization, and Diversity in Drug Development

Cited by 5 publications

References 4 publications

Trastuzumab‐based nanomedicines for breast cancer therapy: Recent advances and future opportunities

Trastuzumab‐based nanomedicines for breast cancer therapy: Recent advances and future opportunities

Basket Trials: Past, Present, and Future

Drug development for major chronic health conditions—aligning with growing public health needs: Proceedings from a multistakeholder think tank

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