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

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

doi:10.3390/cancers12020437

Cited by 22 publications

(15 citation statements)

References 23 publications

(33 reference statements)

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“…After approval of the first liposomal formulation with drug doxorubicin, Doxil ® by FDA and EMA, the market has seen the launch of many anticancer regimes (Barenholz, 2012;Leo et al, 2020). Sufficing the emerging need, the paradigm of approval has also come across inclination for theranostics including recently approved Novartis radiopharmaceuticals, Lutathera ® ([ 177 Lu]Lu-DOTA-TATE) for treatment of neuroendocrine tumor (Hennrich and Kopka, 2019) and many are being explored in the clinic (Table 2).…”

Section: Preclinical and Clinical Outcomementioning

confidence: 99%

Designing and Immunomodulating Multiresponsive Nanomaterial for Cancer Theranostics

Khan

Dias²,

Neekhra

et al. 2021

Front. Chem.

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Cancer has been widely investigated yet limited in its manifestation. Cancer treatment holds innovative and futuristic strategies considering high disease heterogeneity. Chemotherapy, radiotherapy and surgery are the most explored pillars; however optimal therapeutic window and patient compliance recruit constraints. Recently evolved immunotherapy demonstrates a vital role of the host immune system to prevent metastasis recurrence, still undesirable clinical response and autoimmune adverse effects remain unresolved. Overcoming these challenges, tunable biomaterials could effectively control the co-delivery of anticancer drugs and immunomodulators. Current status demands a potentially new approach for minimally invasive, synergistic, and combinatorial nano-biomaterial assisted targeted immune-based treatment including therapeutics, diagnosis and imaging. This review discusses the latest findings of engineering biomaterial with immunomodulating properties and implementing novel developments in designing versatile nanosystems for cancer theranostics. We explore the functionalization of nanoparticle for delivering antitumor therapeutic and diagnostic agents promoting immune response. Through understanding the efficacy of delivery system, we have enlightened the applicability of nanomaterials as immunomodulatory nanomedicine further advancing to preclinical and clinical trials. Future and present ongoing improvements in engineering biomaterial could result in generating better insight to deal with cancer through easily accessible immunological interventions.

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Section: Preclinical and Clinical Outcomementioning

confidence: 99%

Designing and Immunomodulating Multiresponsive Nanomaterial for Cancer Theranostics

Khan

Dias²,

Neekhra

et al. 2021

Front. Chem.

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“…They are biocompatible, of low immunogenicity, and they increase the solubility of a wide range of chemotherapeutics [187]. Several liposomal formulations, namely Doxil ® /Caelyx™ (pegylated liposomal doxorubicin), Myocet ® (non-pegylated liposomal doxorubicin), DaunoXome ® (liposomal daunorubicin), Marqibo ® (liposomal vincristine), Mepact ® (liposomal mifamurtide), and Onivyde ® (pegylated liposomal irinotecan) have already been EMA and/or FDA-approved for the treatment of various cancer types, including BC [164,188].…”

Section: Liposomesmentioning

confidence: 99%

Epigenetics in Breast Cancer Therapy—New Strategies and Future Nanomedicine Perspectives

Buociková

Ríos-Mondragón

Pilalis

et al. 2020

Cancers

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Epigenetic dysregulation has been recognized as a critical factor contributing to the development of resistance against standard chemotherapy and to breast cancer progression via epithelial-to-mesenchymal transition. Although the efficacy of the first-generation epigenetic drugs (epi-drugs) in solid tumor management has been disappointing, there is an increasing body of evidence showing that epigenome modulation, in synergy with other therapeutic approaches, could play an important role in cancer treatment, reversing acquired therapy resistance. However, the epigenetic therapy of solid malignancies is not straightforward. The emergence of nanotechnologies applied to medicine has brought new opportunities to advance the targeted delivery of epi-drugs while improving their stability and solubility, and minimizing off-target effects. Furthermore, the omics technologies, as powerful molecular epidemiology screening tools, enable new diagnostic and prognostic epigenetic biomarker identification, allowing for patient stratification and tailored management. In combination with new-generation epi-drugs, nanomedicine can help to overcome low therapeutic efficacy in treatment-resistant tumors. This review provides an overview of ongoing clinical trials focusing on combination therapies employing epi-drugs for breast cancer treatment and summarizes the latest nano-based targeted delivery approaches for epi-drugs. Moreover, it highlights the current limitations and obstacles associated with applying these experimental strategies in the clinics.

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“…The European Medicines Agency validated the use of neratinib only in HER2-positive early BC with hormone-receptor-positive disease, since the benefit was essentially restricted to this population [ 43 ]. Yet, due to the small magnitude of the clinical advantage and thereby to an unequal reimbursement across the different countries, its routine use remains limited [ 44 ]. In addition, neratinib was evaluated vs. trastuzumab in the I-SPY2 trial in combination with chemotherapy in the neoadjuvant treatment of HER2-positive early BC (NCT01042379) [ 45 ].…”

Section: Novel Anti-her2 Antibodiesmentioning

confidence: 99%

New Therapeutics in HER2-Positive Advanced Breast Cancer: Towards a Change in Clinical Practices?

Mezni

Vicier

Guérin

et al. 2020

Cancers

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Over the last few decades, improved knowledge of oncogenic activation mechanisms of HER2 protein has led to the development of HER2 targeted therapies that are currently commonly used in HER2-positive advanced breast cancer, such as trastuzumab, lapatinib, pertuzumab, and ado-trastuzumab emtansine. The management of this breast cancer subgroup has thus been revolutionized and its prognosis has changed dramatically. Nevertheless, HER2-positive advanced breast cancer remains an incurable disease and resistance to conventional anti-HER2 drugs is almost unavoidable. Nowadays, biochemical and pharmaceutical advances are meeting the challenge of developing increasingly sophisticated therapies directed against HER2, including novel anti HER2 antibodies with increased affinity. New antibody-drug conjugates (ADC) with more advanced pharmacological properties, and dual targeting of epitopes via bispecific monoclonal antibodies are also emerging. In addition, more potent and more specific HER2 tyrosine kinase inhibitors have shown interesting outcomes and are under development. Finally, researchers’ interest in tumor microenvironment, particularly tumor-infiltrating lymphocytes, and the major role that signaling pathways, such as the PI3K/AKT/mTOR pathway, play in the development of resistance to anti-HER2 therapies have spurred the development of clinical trials evaluating innovative combinations of anti-HER2 with PD-1/PDL-1, CDK4/6 and PI3K inhibitors. However, several questions remain unresolved, like the optimal management of HER2-positive/HR-positive advanced breast cancer and the identification of predictive biomarkers to better define populations that can benefit most from these new therapies and approaches.

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

Cited by 22 publications

References 23 publications

Designing and Immunomodulating Multiresponsive Nanomaterial for Cancer Theranostics

Designing and Immunomodulating Multiresponsive Nanomaterial for Cancer Theranostics

Epigenetics in Breast Cancer Therapy—New Strategies and Future Nanomedicine Perspectives

New Therapeutics in HER2-Positive Advanced Breast Cancer: Towards a Change in Clinical Practices?

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