Bevacizumab for Advanced Breast Cancer: Hope, Hype, and Hundreds of Headlines

Fralick, Michael; Ray, Monali; Fung, Christina; Booth, Christopher M.; Mallick, Ranjeeta; Clemons, Mark

doi:10.1634/theoncologist.2013-0160

Cited by 7 publications

(9 citation statements)

References 24 publications

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“…A study of 359 articles published in North American newspapers about bevacizumab and breast cancer before, during and after the FDA approval period showed that, prior to the FDA approval, the reports tended to present bevacizumab positively: 82 % of articles noted efficacy and only 23 and 24 % reported the lack of efficacy or side effects respectively [ 35 ]. The proportions of positive headline tone (36 % before approval, 18 % during approval, 9 % after approval, p = 0.0002) and positive article tone (42 %, 19 %, 15 %, p < 0.0001) declined with each study period.…”

Section: Resultsmentioning

confidence: 99%

“…Media reports may be informed by sensational statements or press releases issued by researchers, their institutions and the pharmaceutical industry which all stand to benefit in terms of reputation and profits [ 54 ]. The study of newspaper reports on bevacizumab and breast cancer [ 35 ] showed that bevacizumab was presented very positively prior to the FDA approval and this may have heartened perceptions among the public of the high therapeutic value of this medicine.…”

Section: Discussionmentioning

confidence: 99%

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Regulatory withdrawal of medicines marketed with uncertain benefits: the bevacizumab case study

Vitry

Nguyen

Entwistle

et al. 2015

J of Pharm Policy and Pract

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BackgroundWithdrawal of conditional regulatory approval or subsidization of new medicines when subsequent evidence does not confirm early trial results may not be well understood or accepted by the public. ObjectivesWe present a case study of the US Food and Drug Administration (FDA)’s decision to withdraw the indication of bevacizumab for the treatment of advanced breast cancer and include an analysis of the reactions of stakeholders with a view to identifying opportunities for improving risk management for new medicines with conditional approval or funding.MethodsWe drew on a range of information sources, including FDA documents, medical journals and media reports, to describe the evidentiary basis of the FDA decisions. We analysed the reactions and perspectives of the stakeholders.ResultsIn 2008 bevacizumab was granted conditional approval for treatment of advanced breast cancer by the FDA pending submission of supplementary satisfactory evidence. In 2011 the FDA decision to withdraw the indication was met with a hostile reaction from many clinicians and cancer survivors. There were different interpretations of the therapeutic value of bevacizumab with strong beliefs among cancer survivors that the medicine was effective and potential harm was manageable. High expectations of the public may have been encouraged by overly positive media reports and limited understanding by the public of the complexity of the scientific evaluation of new medicines and of the regulatory processes.ConclusionsImproving understanding and acceptance of approval or coverage schemes conditional to evidence development may require the development of risk management plans by regulatory and funding institutions. They may include a range of strategies such as requirements for formal patient acknowledgment of the conditional availability of the medicine, ‘black-triangle’ equivalent labels that identify full approval is based on pending evidence, and ongoing communication with the media, public and health professionals.

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Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Regulatory withdrawal of medicines marketed with uncertain benefits: the bevacizumab case study

Vitry

Nguyen

Entwistle

et al. 2015

J of Pharm Policy and Pract

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“…After the accelerated approval of bevacizumab for breast cancer, the drug’s sponsoring pharmaceutical company completed two additional clinical trials and submitted the data from those studies to the FDA. These data showed a very modest effect on cancer without evidence of improved survival or improvement in quality of life compared with taking standard chemotherapy alone—thus the FDA revoked the approval in 2011 ( 103 ).…”

Section: Considerations For Trials That Target Either Health Span or mentioning

confidence: 99%

Strategies and Challenges in Clinical Trials Targeting Human Aging

Newman

Milman

Hashmi

et al. 2016

GERONA

125

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Interventions that target fundamental aging processes have the potential to transform human health and health care. A variety of candidate drugs have emerged from basic and translational research that may target aging processes. Some of these drugs are already in clinical use for other purposes, such as metformin and rapamycin. However, designing clinical trials to test interventions that target the aging process poses a unique set of challenges. This paper summarizes the outcomes of an international meeting co-ordinated by the NIH-funded Geroscience Network to further the goal of developing a translational pipeline to move candidate compounds through clinical trials and ultimately into use. We review the evidence that some drugs already in clinical use may target fundamental aging processes. We discuss the design principles of clinical trials to test such interventions in humans, including study populations, interventions, and outcomes. As examples, we offer several scenarios for potential clinical trials centered on the concepts of health span (delayed multimorbidity and functional decline) and resilience (response to or recovery from an acute health stress). Finally, we describe how this discussion helped inform the design of the proposed Targeting Aging with Metformin study.

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“…Although bevacizumab has been approved by the European Medicines Agency for the first‐line treatment of metastatic breast cancer in 2007, there are still many controversies in utilizing bevacizumab for breast cancer treatment due to its adverse effects of hypertension, bleeding events, proteinuria and sensory neuropathy . Owing to the failure in demonstrating the clinical benefits of bevacizumab in combined therapy with other chemical agents, in 2011, the FDA banned the use of this drug for metastatic breast cancer treatment after its first approval in 2008 . Fortunately, the latest research has verified the usefulness of bevacizumab in first‐line standard chemotherapy for metastatic breast cancer treatment …”

Section: Targeted Biopharmaceuticals For Breast Cancer Treatmentmentioning

confidence: 99%

Cell‐specific biomarkers and targeted biopharmaceuticals for breast cancer treatment

Liu

Yang

et al. 2016

Cell Proliferation

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Breast cancer is the second leading cause of cancer death among women, and its related treatment has been attracting significant attention over the past decades. Among the various treatments, targeted therapy has shown great promise as a precision treatment, by binding to cancer cell-specific biomarkers. So far, great achievements have been made in targeted therapy of breast cancer. In this review, we first discuss cell-specific biomarkers, which are not only useful for classification of breast cancer subtyping but also can be utilized as goals for targeted therapy. Then, the innovative and generic-targeted biopharmaceuticals for breast cancer, including monoclonal antibodies, non-antibody proteins and small molecule drugs, are reviewed. Finally, we provide our outlook on future developments of biopharmaceuticals, and provide solutions to problems in this field.

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Bevacizumab for Advanced Breast Cancer: Hope, Hype, and Hundreds of Headlines

Abstract: Learning Objectives Summarize findings regarding the media's portrayal of bevacizumab with each phase of therapeutic development. Identify media sources of information about bevacizumab in each phase of therapeutic development.

Cited by 7 publications

References 24 publications

Regulatory withdrawal of medicines marketed with uncertain benefits: the bevacizumab case study

Regulatory withdrawal of medicines marketed with uncertain benefits: the bevacizumab case study

Strategies and Challenges in Clinical Trials Targeting Human Aging

Cell‐specific biomarkers and targeted biopharmaceuticals for breast cancer treatment

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