Clinical experience with ramucirumab: outcomes in breast cancer

Coyne, Geraldine Helen O'Sullivan; Burotto, Mauricio

doi:10.1517/14712598.2014.939069

Cited by 5 publications

(2 citation statements)

References 39 publications

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“…In December 2014, the FDA approved its use in the treatment of NSCLC. However, ramucirumab failed to achieve the primary end point in a breast cancer study [41].…”

Section: Monoclonal Antibodiesmentioning

confidence: 99%

Orphan drug approvals of 2014: Europe and the United States

Norman¹

2015

Expert Opinion on Orphan Drugs

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Introduction: The development of orphan drugs for the treatment of rare diseases has attracted increasing interest from the pharmaceutical industry. The year 2014 saw an increased level of orphan drug approvals, possibly reflecting the increased attention given to rare diseases. Areas covered: The review discusses all the orphan drug approvals of 2014. It first considers the 12 European approvals, which includes eight novel chemical entities (NCEs). It then considers the 44 US approvals, which includes 17 NCEs. The discrepancies in approval timings between these markets are then discussed. Expert opinion: The increase in the number of orphan drug approvals appears attributable both to an increased awareness of rare diseases and to the FDA's efforts to expedite the approval of drugs to treat rare diseases and serious conditions. Europe's failure to follow suit appears to be one factor in the delays between US and European approvals of orphan drugs.

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“…In December 2014, the FDA approved its use in the treatment of NSCLC. However, ramucirumab failed to achieve the primary end point in a breast cancer study [41].…”

Section: Monoclonal Antibodiesmentioning

confidence: 99%

Orphan drug approvals of 2014: Europe and the United States

Norman¹

2015

Expert Opinion on Orphan Drugs

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“… 35 For these reasons, targeting the VEGFR-2 is a promising therapeutic approach in MBC patients, and ramucirumab is the only recombinant human monoclonal antibody that prevents the binding of the VEGF ligand to VEGFR-2 to be tested in MBC patients. 40 …”

Section: Ramucirumab In Metastatic Breast Cancer: a Stinging Setbackmentioning

confidence: 99%

Ramucirumab: preclinical research and clinical development

Aprile

Rijavec

Fontanella

et al. 2014

OTT

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Ramucirumab (IMC-1121B, LY3009806), a fully humanized monoclonal antibody directed against the extracellular domain of vascular endothelial growth factor receptor 2 (VEGFR-2), is a new therapeutic option that selectively inhibits the human VEGFR-2 with a much greater affinity than its natural ligands. Based on the promising results of both preclinical and early clinical studies, ramucirumab has been tested in different tumor types either alone or in combination with chemotherapy. While it has recently been granted its first US Food and Drug Administration approval for use as a single agent in patients with advanced or metastatic gastric cancer or gastroesophageal junction carcinoma, its role for metastatic breast cancer or advanced non-small-cell lung cancer is still debated. The aims of this review are to recall and discuss the most significant preclinical and clinical studies that led to the development of ramucirumab and to present the results of the randomized clinical trials that have tested its efficacy in different malignancies, including gastric and lung cancer.

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