Breast cancer drug approvals by the US FDA from 1949 to 2018

Leo, Chandra P.; Leo, Cornelia; Szucs, Thomas D.

doi:10.1038/d41573-019-00201-w

Cited by 29 publications

(24 citation statements)

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“…We showed that over this 70-year period, breast cancer accounted for the highest number of FDA drug approvals among all solid tumor entities. Furthermore, we found that the rate of new drug approvals for breast cancer has dramatically increased over the last 30 years, compared to earlier decades, in part driven by the development of targeted therapeutics [3]. This trend matches the acceleration of new drug approvals seen across the field of oncology as a whole [4,5], which results from the impressive progress in translational cancer research and from the evolving regulatory environment [6,7].…”

Section: Introductionmentioning

confidence: 53%

“…As shown in our earlier study, breast cancer was the solid tumor entity with the highest number of newly FDA-approved drugs during the 70-year period from 1949 (the year of the first-ever approval of an oncology drug, mechlorethamine) to 2018 [3]. If one includes the field of hematologic oncology, breast cancer resides in third place, behind leukemias and lymphomas.…”

Section: Discussionmentioning

confidence: 74%

“…In a previous study, we analyzed all United States Food and Drug Administration (FDA) approvals of new breast cancer drugs between 1949 and 2018 [3]. We showed that over this 70-year period, breast cancer accounted for the highest number of FDA drug approvals among all solid tumor entities.…”

Section: Introductionmentioning

confidence: 99%

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FDA and EMA Approvals of New Breast Cancer Drugs—A Comparative Regulatory Analysis

Leo¹,

Hentschel²,

Szucs

et al. 2020

Cancers

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Breast cancer is the most common cancer in women worldwide and the solid tumor type for which the highest number of drugs have been approved to date. This study examines new drug approvals for breast cancer by the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA), based on an analysis of regulatory documents from both agencies for the period from 1995 to 2018. Of the 29 breast cancer drugs approved over this time span, 17 received positive decisions from both the FDA and EMA, including all drugs licensed after 2008. Nineteen of the 25 FDA-approved drugs, but none of the EMA approvals, benefited from special regulatory pathways (such as fast track, breakthrough therapy, or priority review). In the U.S.A., four accelerated approvals were granted (of which one, for bevacizumab, was later revoked), while only two drugs received provisional approvals following EMA review. New breast cancer drugs were approved approximately twelve months earlier in the United States than in Europe. These results suggest that a broader use of special regulatory pathways by EMA could help to accelerate access to novel drugs for European breast cancer patients.

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Section: Introductionmentioning

confidence: 53%

Section: Discussionmentioning

confidence: 74%

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FDA and EMA Approvals of New Breast Cancer Drugs—A Comparative Regulatory Analysis

Leo¹,

Hentschel²,

Szucs

et al. 2020

Cancers

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“…Breast cancer is the most common malignancy in women [ 22 ]. The treatment of breast cancer in early stages involves a multitude of approaches, all following an inhibition of the proliferation, and invasion of cancer cells.…”

Section: Discussionmentioning

confidence: 99%

Antipsychotics drug aripiprazole as a lead against breast cancer cell line (MCF-7) in vitro

et al. 2020

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Breast cancer is the second leading cause of death among women globally. The existing treatment options for breast cancer are largely associated with severe toxicities, and lower efficacies. Therefore, there is an urgent need for the development of non-toxic effective drugs against breast cancer. For this purpose, drug repositioning strategy was used to evaluate the anti-cancer potential of a library of heterocyclic drugs. The major advantage of drug repurposing is that the pharmacokinetic, pharmacodynamic, and toxicity profiles of drugs are well documented. In the current study, we screened 97 drugs of different chemical classes, and among them aripiprazole, an antipsychotic drug, was found to be sufficiently active against breast cancer cell line MCF-7. Aripiprazole showed a cytotoxicity (IC 50 = 12.1 ± 0.40 μM) to MCF-7 cells, comparable to the standard anticancer drug doxorubicin (IC 50 = 1.25 ± 0.34 μM). Aripiprazole was also found to be active against other cancer cell lines, including MDA-MB-231 (IC 50 = 19.83 ± 0.27 μM), AU565 (IC 50 = 18.02 ± 0.44 μM), and BT-474 (IC 50 = 36.42 ± 0.12 μM). Aripiprazole significantly inhibited the cell cycle progression at subG 0 G 1 phase, and enhanced apoptosis in MCF-7 breast cancer cells. The drug was also able to significantly increase the nuclear condensation, and modulated the expression of certain genes involved in breast cancer, such as caspases 3, and 9, BAK-1, C-MYC, BCL2L1, BCL-10, and BCL-2. Further studies are needed to explore the effect of aripiprazole on intrinsic and extrinsic pathways of apoptosis in cancer cells.

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“…To date, there are 34 drugs approved for BC treatment [88,89], a relatively high number, compared to other solid tumors. However, only 5% of molecules that show anticancer activity in preclinical studies are approved upon demonstration of sufficient efficacy in phase III clinical trials [90].…”

Section: Breast Cancermentioning

confidence: 99%

Alzheimer’s Disease, and Breast and Prostate Cancer Research: Translational Failures and the Importance to Monitor Outputs and Impact of Funded Research

Herrmann

Bernasconi

McCarthy

et al. 2020

Animals

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Dementia and cancer are becoming increasingly prevalent in Western countries. In the last two decades, research focused on Alzheimer’s disease (AD) and cancer, in particular, breast cancer (BC) and prostate cancer (PC), has been substantially funded both in Europe and worldwide. While scientific research outcomes have contributed to increase our understanding of the disease etiopathology, still the prevalence of these chronic degenerative conditions remains very high across the globe. By definition, no model is perfect. In particular, animal models of AD, BC, and PC have been and still are traditionally used in basic/fundamental, translational, and preclinical research to study human disease mechanisms, identify new therapeutic targets, and develop new drugs. However, animals do not adequately model some essential features of human disease; therefore, they are often unable to pave the way to the development of drugs effective in human patients. The rise of new technological tools and models in life science, and the increasing need for multidisciplinary approaches have encouraged many interdisciplinary research initiatives. With considerable funds being invested in biomedical research, it is becoming pivotal to define and apply indicators to monitor the contribution to innovation and impact of funded research. Here, we discuss some of the issues underlying translational failure in AD, BC, and PC research, and describe how indicators could be applied to retrospectively measure outputs and impact of funded biomedical research.

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Breast cancer drug approvals by the US FDA from 1949 to 2018

Cited by 29 publications

References 0 publications

FDA and EMA Approvals of New Breast Cancer Drugs—A Comparative Regulatory Analysis

FDA and EMA Approvals of New Breast Cancer Drugs—A Comparative Regulatory Analysis

Antipsychotics drug aripiprazole as a lead against breast cancer cell line (MCF-7) in vitro

Alzheimer’s Disease, and Breast and Prostate Cancer Research: Translational Failures and the Importance to Monitor Outputs and Impact of Funded Research

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