Abemaciclib: First Global Approval

<div><br></div><div><i>Funding:</i> The preparation of this review was not supported by any external funding.</div><div><i><br></i></div><div><i>Conflicts of interest:</i> During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. Esther Kim is a salaried employee of Adis/Springer, is responsible for the article content and declares no relevant conflicts of interest.</div><div><br></div><div>Additional information about this Adis Drug Review can be found at <b><a href="http://www.springer.com/gp/adis/products-services/adis-journals-newsletters/adis-drug-reviews">here</a>.</b></div><div><br></div><div>Abstract</div><div><br></div><div>Abemaciclib (Verzenio™) is an orally administered inhibitor of cyclin-dependent kinases 4 and 6 that is being developed by Eli Lilly and Company. Abemaciclib has been approved in the USA for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, in combination with fulvestrant in women with disease progression following endocrine therapy, and as monotherapy in adult patients with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting. In addition, abemaciclib is in various stages of development internationally for HR-positive breast cancer, non-small lung cancer and a variety of other cancers. This article summarizes the milestones in the development of abemaciclib leading to this first approval for the treatment of patients with HR-positive, HER2-negative advanced or metastatic breast cancer. Access to the full article can be found <b><a href="https://link.springer.com/article/10.1007/s40265-017-0840-z">here</a>.</b></div><div><br></div><div>© Springer International Publishing AG, part of Springer Nature 2017</div

Tivozanib: First Global Approval

<div>Compliance with Ethical Standards</div><div><i><br></i></div><div><i>Funding:</i> The preparation of this review was not supported by any external funding.</div><div><i><br></i></div><div><i>Conflicts of interest</i>: During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the author on the basis of scientific completeness and accuracy. Esther Kim is a salaried employee of Adis/Springer, is responsible for the article content and declares no relevant conflicts of interest.</div><div><br></div><div>Additional information about this Adis Drug Review can be found <b><a href="http://www.springer.com/gp/adis/products-services/adis-journals-newsletters/adis-drug-reviews">here</a>.</b></div><div><br></div><div>Abstract</div><div><br></div><div>Tivozanib (Fotivda®) is an oral, potent and highly selective vascular endothelial growth factor receptor (VEGFR) inhibitor that has been approved in the EU, Iceland and Norway for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC) and for adult patients who are VEGFR and mammalian target of rapamycin (mTOR) pathway inhibitor-naive following disease progression after one prior treatment with cytokine therapy for advanced RCC. Tivozanib is at various stages of development in other countries for advanced RCC and advanced solid tumours. This article summarizes the milestones in the development of tivozanib leading to this first global approval in Europe for the treatment of adults with advanced RCC. Access to the full article can be found <b><a href="http://dx.doi.org/10.1007/s40265-017-0825-y">here</a>.</b></div><div><br></div><div>© Springer International Publishing AG, part of Springer Nature 2017</div><div><br></div

Valbenazine: First Global Approval

<div><i>Disclosure:</i> The preparation of this review was not supported by any external funding. During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. E. S. Kim is a salaried employee of Adis, Springer SBM.</div><div><br></div><div>Additional information about this Adis Drug Review can be found<b> <a href="http://www.springer.com/gp/adis/products-services/adis-journals-newsletters/adis-drug-reviews">here</a>.</b></div><div><br></div><div>Abstract</div><div><br></div><div>Valbenazine (Ingrezza™) is an orally bioavailable, selective, vesicular monoamine transporter 2 (VMAT2) inhibitor being developed by Neurocrine Biosciences for the treatment of various central nervous system disorders. Valbenazine has been approved in the USA for the treatment of adults with tardive dyskinesia (TD), is at various stages of development in other countries for TD and is in phase 2 development in the USA for Tourette syndrome. This article summarizes the milestones in the development of valbenazine leading to its first global approval in the USA for the treatment of adults with TD.</div><div>Access to the full article can be found <b><a href="http://dx.doi.org/10.1007/s40265-017-0770-9">here</a>.</b></div><div><br></div><div>© Springer International Publishing AG, part of Springer Nature 2017</div><div><br></div

Additional file 1: Figure S1. of Cross-sectional association of volume, blood pressures, and aortic stiffness with left ventricular mass in incident hemodialysis patients: the Predictors of Arrhythmic and Cardiovascular Risk in End-Stage Renal Disease (PACE) study

Boxplot of left ventricular mass index (LVMI) and quartiles of systolic or diastolic blood pressures measured as predialysis 3-month average BP measurement stratified by ethnicity. Figure S2: Boxplot of left ventricular mass index (LVMI) and quartiles of systolic or diastolic blood pressures measured as prior to clinic BP measurement stratified by ethnicity. Figure S3: Boxplot of left ventricular mass index (LVMI) and quartiles of systolic or diastolic blood pressures measured as non-dialysis supine BP measurement stratified by ethnicity. Table S1: Independent associations of predialysis blood pressure, arterial, and volume measures with LVMI by linear regression among incident hemodialysis participants. Table S2: Independent associations of blood pressure prior to study visit, arterial, and volume measures withLVMI by linear regression among incident hemodialysis participants. Table S3: Independent associations of mean arterial pressure, arterial, and volume measures with LVMI by linear regression among incident hemodialysis participants. Table S4: Independent associations of pulse pressures, arterial, and volume measures with LVMI by linear regression among incident hemodialysis participants. Table S5: Association of preload and afterload measures with LVMI by linear regression among incident hemodialysis participants stratified by ethnicity. Table S6: Association of preload and afterload measures with LVMI by linear regression among incidenthemodialysis participants stratified by 3 month average IDWG groups. Table S7: Association of preload and afterload measures with LVMI by linear regression among incident hemodialysis participants stratified by β-blocker medication. Table S8: Association of preload and afterload measures with LVMI by linear regression among incident hemodialysis participants stratified by renin-angiotensin-aldosterone system (RAAS) blockade use. Table S9: Association of preload and afterload measures with LVMI by linear regression among incident hemodialysis participants stratified by history of congestive heart failure. Table S10: Association of hemoglobin with LVMI by linear regression among incident hemodialysis participants. (DOCX 97 kb