The importance of greater speed in drug development for advanced malignancies

Stewart, Andrew; Wheatley‐Price, Paul; Batist, Gerald; Kantarjian, Hagop M.; Schiller, Joan H.; Clemons, Mark; Bradford, John Peter; Gillespie, Laurel; Kurzrock, Razelle

doi:10.1002/cam4.1454

Cited by 31 publications

(34 citation statements)

References 75 publications

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“…Such delayed regulatory decisions have real-life consequences: a recent study calculated that accelerating the approval of a single new cancer drug by one year could lead to thousands of life-years gained for patients. However, the impact for any particular drug will depend on the achievable (overall) survival benefit and the number of eligible patients [24]. Moreover, pricing and reimbursement decisions on the national level frequently cause further delays in patients' access to newly approved medicines [25,26].…”

Section: Discussionmentioning

confidence: 99%

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: Discussionmentioning

confidence: 99%

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

Leo¹,

Hentschel²,

Szucs

et al. 2020

Cancers

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“…Another way of reducing cancer medicine prices is to lower cancer drug development costs. Table outlines some strategies to increase clinical trial efficiency …”

Section: Optimizing Cancer Medicine Researchmentioning

confidence: 99%

Enhancing global access to cancer medicines

Cortés

Peréz-García

Llombart-Cussac

et al. 2020

CA A Cancer J Clinicians

153

108

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Globally, cancer is the second leading cause of death, with numbers greatly exceeding those for human immunodeficiency virus/acquired immunodeficiency syndrome, tuberculosis, and malaria combined. Limited access to timely diagnosis, to affordable, effective treatment, and to high‐quality care are just some of the factors that lead to disparities in cancer survival between countries and within countries. In this article, the authors consider various factors that prevent access to cancer medicines (particularly access to essential cancer medicines). Even if an essential cancer medicine is included on a national medicines list, cost might preclude its use, it might be prescribed or used inappropriately, weak infrastructure might prevent it being accessed by those who could benefit, or quality might not be guaranteed. Potential strategies to address the access problems are discussed, including universal health coverage for essential cancer medicines, fairer methods for pricing cancer medicines, reducing development costs, optimizing regulation, and improving reliability in the global supply chain. Optimizing schedules for cancer therapy could reduce not only costs, but also adverse events, and improve access. More and better biomarkers are required to target patients who are most likely to benefit from cancer medicines. The optimum use of cancer medicines depends on the effective delivery of several services allied to oncology (including laboratory, imaging, surgery, and radiotherapy). Investment is necessary in all aspects of cancer care, from these supportive services to technologies, and the training of health care workers and other staff.

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“…This clearly implies that a considerable amount of life-years could be saved plausibly through increased efficiency of novel drug development for advanced neoplasms. 88 Further, in the development of different oral agents against cancer, dosing options are random and limited by pills' size. Prasad et al reported that this limited dosing options frequently resulted in large dose adjustments in response to toxicity which might lead to reduced real-world clinical effectiveness of oral anticancer agents resulting in differed outcomes than those achieved in registration trials.…”

Section: Drug Development Duration and Dosing Optionsmentioning

confidence: 99%

Cancer drug development: The missing links

Kunnumakkara

Bordoloi

Sailo

et al. 2019

Exp Biol Med (Maywood)

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Although better science and technology has been linked with better health care, however, reality is much different. Although America and most of Europe are equipped with most advanced science and technology, paradoxically cancer incidence is highest in the world. This indicates that science and technology alone is not sufficient in treating diseases like cancer. It is also now well recognized that more than 95% of the drugs/compounds that kill either cancer cells in culture or regress the tumors in animals, fail in phase I clinical trials in humans, indicating that most pre-clinical models of cancer are inadequate. In addition, most of the anticancer drugs that are approved by the regulatory agencies such as FDA either has no effect on the overall survival of the cancer patient or may provide an increase in few months in overall survival. This is despite the fact that most targeted therapies that are currently available are highly expensive; thus suggesting the lack of affordability. This review is meant to focus on some of these problems in detail and then provide potential solutions since most cancers are caused by multiple genes, and thus multi-targeted therapies are needed such as natural products which are inexpensive, safe and have been used for thousands of years for both prevention and treatment of cancer. Impact statement The success rate for cancer drugs which enter into phase 1 clinical trials is utterly less. Why the vast majority of drugs fail is not understood but suggests that pre-clinical studies are not adequate for human diseases. In 1975, as per the Tufts Center for the Study of Drug Development, pharmaceutical industries expended 100 million dollars for research and development of the average FDA approved drug. By 2005, this figure had more than quadrupled, to $1.3 billion. In order to recover their high and risky investment cost, pharmaceutical companies charge more for their products. However, there exists no correlation between drug development cost and actual sale of the drug. This high drug development cost could be due to the reason that all patients might not respond to the drug. Hence, a given drug has to be tested in large number of patients to show drug benefits and obtain significant results.

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The importance of greater speed in drug development for advanced malignancies

Cited by 31 publications

References 75 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

Enhancing global access to cancer medicines

Cancer drug development: The missing links

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