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https://www.readbyqxmd.com/read/28417244/ribociclib-first-global-approval
#1
Yahiya Y Syed
Ribociclib is an oral, small-molecule inhibitor of cyclin-dependent kinase (CDK) 4 and 6 that is under development by Novartis for the treatment of cancer. CDKs play an important role in cell cycle progression and cellular proliferation, and inhibition of these kinases with ribociclib results in G1 phase cell-cycle arrest. Ribociclib, in combination with an aromatase inhibitor, was recently approved in the USA for the first-line treatment of advanced breast cancer and has been submitted for approval in the EU for this indication...
April 17, 2017: Drugs
https://www.readbyqxmd.com/read/28405961/treatment-patterns-and-early-outcomes-of-alk-positive-non-small-cell-lung-cancer-patients-receiving-ceritinib-a-chart-review-study
#2
Edmond Bendaly, Anand A Dalal, Kenneth Culver, Philip Galebach, Iryna Bocharova, Rebekah Foster, Medha Sasane, Alexander R Macalalad, Annie Guérin
INTRODUCTION: This study aimed to provide the first real-world description of the characteristics, treatments, dosing patterns, and early outcomes of patients with ALK-positive non-small cell lung cancer (NSCLC) who received ceritinib in US clinical practice. METHODS: US oncologists provided data from medical charts of adult patients diagnosed with locally advanced or metastatic ALK-positive NSCLC who received ceritinib following crizotinib. Patient characteristics, treatment patterns, ceritinib dosing, early outcomes, and occurrence of gastrointestinal adverse events (AEs) by dose and instructions on food intake were assessed, and Kaplan-Meier analysis was used to describe clinician-defined progression-free survival (PFS) on ceritinib...
April 12, 2017: Advances in Therapy
https://www.readbyqxmd.com/read/28405488/multiple-intravitreal-ranibizumab-injections-for-persistant-choroidal-neovascularization-associated-with-presumed-ocular-histoplasmosis-syndrome
#3
Turgut Yılmaz, Seyhan Dikci, Oğuzhan Genç, Kayhan Mutlu
Presumed ocular histoplasmosis syndrome (POHS) is a clinical entity that is characterized by small, round, discrete, macular or mid peripheral atrophic (punched out) chorioretinal lesions (histo spots), peripapillary scarring, choroidal neovascularization (CNV), and the absence of anterior uveitis and vitritis. Diagnosis of this disorder is based upon characteristic clinical findings and a positive histoplasmin skin test or residence in an endemic region for Histoplasma capsulatum. There is no active systemic disease during diagnosis of POHS...
April 2017: Turkish Journal of Ophthalmology
https://www.readbyqxmd.com/read/28397079/secukinumab-is-efficacious-and-safe-in-hispanic-patients-with-moderate-to-severe-plaque-psoriasis-pooled-analysis-of-four-phase-3-trials
#4
Sandra Adsit, Enrique Rivas Zaldivar, Howard Sofen, Ignacio Dei-Cas, César Maldonado García, Elkin O Peñaranda, Luís Puig, Xiangyi Meng, Todd Fox, Adriana Guana
INTRODUCTION: There is little evidence available on the efficacy and safety of biologic therapies for the treatment of psoriasis in Hispanic patients. Secukinumab is demonstrated to be highly effective for clearing psoriasis. The aim of this study was to compare the efficacy and safety of secukinumab in Hispanic and non-Hispanic patients. METHODS: Data were pooled from four phase 3 studies of secukinumab in patients with moderate-to-severe plaque psoriasis. Patients who self-identified as Hispanic were included in the Hispanic subgroup...
April 10, 2017: Advances in Therapy
https://www.readbyqxmd.com/read/28394705/establishment-of-a-cohort-for-deep-phenotyping-of-the-immune-response-to-influenza-vaccination-among-elderly-individuals-recruited-from-the-general-population
#5
Manas K Akmatov, Peggy Riese, Marcus May, Leonhard Jentsch, Malik W Ahmed, Damaris Werner, Anja Rösel, Megan Tyler, Kevin Pessler, Jana Prokein, Inga Bernemann, Norman Klopp, Blair Prochnow, Stephanie Trittel, Aravind Tallam, Thomas Illig, Christoph Schindler, Carlos A Guzmán, Frank Pessler
Elderly individuals have the highest burden of disease from influenza infection but also the lowest immune response to influenza vaccination. A better understanding of the host response to influenza vaccination in the elderly is therefore urgently needed. We conducted a biphasic prospective, population-based study from Dec. 2014 to May 2015 (pilot study) and Sept. 2015 to May 2016 (main study). Individuals 65-80 y of age were randomly selected from the residents' registration office in Hannover, Germany, for the pilot (n = 34) and main study (n = 200)...
April 10, 2017: Human Vaccines & Immunotherapeutics
https://www.readbyqxmd.com/read/28384675/vascular-safety-of-ranibizumab-in-patients-with-diabetic-macular-edema-a-pooled-analysis-of-patient-level-data-from-randomized-clinical-trials
#6
Marco A Zarbin, Cornelia Dunger-Baldauf, Zdenka Haskova, Prashil Koovejee, Marie-Catherine Mousseau, Philippe Margaron, Howard Snow, Paul E Beaumont, Giovanni Staurenghi, Steven Francom
Importance: Patients with diabetic macular edema (DME) are at high risk of vascular complications, including stroke and myocardial infarction (MI). Concerns have been raised that intravitreal dosing of vascular endothelial growth factor inhibitors in DME could be associated with an increase in cardiovascular and cerebrovascular adverse events. Objective: To evaluate the cardiovascular and cerebrovascular safety of ranibizumab, 0.5 mg and 0.3 mg, compared with sham with and without laser in DME...
April 6, 2017: JAMA Ophthalmology
https://www.readbyqxmd.com/read/28379619/blood-pressure-lowering-efficacy-of-renin-inhibitors-for-primary-hypertension
#7
REVIEW
Vijaya M Musini, Kendra Ak Lawrence, Patricia M Fortin, Ken Bassett, James M Wright
BACKGROUND: Hypertension is a chronic condition associated with an increased risk of mortality and morbidity. Renin is the enzyme responsible for converting angiotensinogen to angiotensin I, which is then converted to angiotensin II. Renin inhibitors are a new class of drugs that decrease blood pressure (BP) by preventing the formation of both angiotensin I and angiotensin II. OBJECTIVES: To quantify the dose-related BP lowering efficacy of renin inhibitors compared to placebo in the treatment of primary hypertension...
April 5, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28359238/hr-her2-advanced-breast-cancer-and-cdk4-6-inhibitors-mode-of-action-clinical-activity-and-safety-profiles
#8
Sarah L Sammons, Donna L Topping, Kimberly L Blackwell
Cyclin-dependent kinase (CDK) 4/6 inhibitor-based therapies have shown great promise in improving clinical outcomes for patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer. Addition of a CDK4/6 inhibitor to endocrine therapy increases efficacy and delays disease progression. Successful use of CDK4/6 inhibitor-based therapies in the clinic requires insight into the unique side-effect profiles of this class of agents and effective patient monitoring...
March 30, 2017: Current Cancer Drug Targets
https://www.readbyqxmd.com/read/28356596/fda-approves-novartis-s-cdk4-6-inhibitor
#9
Asher Mullard
No abstract text is available yet for this article.
March 30, 2017: Nature Reviews. Drug Discovery
https://www.readbyqxmd.com/read/28345445/the-role-of-patient-financial-assistance-programs-in-reducing-costs-for-cancer-patients
#10
Leah L Zullig, Steven Wolf, Lisa Vlastelica, Veena Shankaran, S Yousuf Zafar
BACKGROUND: Limited transparency exists regarding eligibility and benefits for patient financial assistance programs (PAPs). OBJECTIVE: To describe oral anticancer medication costs, insurance coverage, and the degree of financial assistance provided by PAPs. METHODS: This was a retrospective study of prescription anticancer medication costs and PAP coverage. The study used data from an academic cancer center's specialty pharmacy. Medication, cost, and coverage data were collected from the specialty pharmacy database for prescriptions filled from January 2013 to November 2015...
April 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28330649/effect-of-sacubitril-valsartan-versus-enalapril-on-glycaemic-control-in-patients-with-heart-failure-and-diabetes-a-post-hoc-analysis-from-the-paradigm-hf-trial
#11
Jelena P Seferovic, Brian Claggett, Sara B Seidelmann, Ellen W Seely, Milton Packer, Michael R Zile, Jean L Rouleau, Karl Swedberg, Martin Lefkowitz, Victor C Shi, Akshay S Desai, John J V McMurray, Scott D Solomon
BACKGROUND: Diabetes is an independent risk factor for heart failure progression. Sacubitril/valsartan, a combination angiotensin receptor-neprilysin inhibitor, improves morbidity and mortality in patients with heart failure with reduced ejection fraction (HFrEF), compared with the angiotensin-converting enzyme inhibitor enalapril, and improves peripheral insulin sensitivity in obese hypertensive patients. We aimed to investigate the effect of sacubitril/valsartan versus enalapril on HbA1c and time to first-time initiation of insulin or oral antihyperglycaemic drugs in patients with diabetes and HFrEF...
March 17, 2017: Lancet Diabetes & Endocrinology
https://www.readbyqxmd.com/read/28314691/prevention-of-everolimus-related-stomatitis-in-women-with-hormone-receptor-positive-her2-negative-metastatic-breast-cancer-using-dexamethasone-mouthwash-swish-a-single-arm-phase-2-trial
#12
Hope S Rugo, Lasika Seneviratne, J Thaddeus Beck, John A Glaspy, Julio A Peguero, Timothy J Pluard, Navneet Dhillon, Leon Christopher Hwang, Chaitali Nangia, Ingrid A Mayer, Timothy F Meiller, Mark S Chambers, Robert W Sweetman, J Randy Sabo, Jennifer K Litton
BACKGROUND: Stomatitis is a class effect associated with the inhibition of mTOR and is associated with everolimus therapy for breast cancer. Topical steroids might reduce stomatitis incidence and severity, and the need for dose reductions and interruptions of everolimus. Anecdotal use of topical steroid oral prophylaxis has been reported in patients with breast cancer. We aimed to assess dexamethasone-based mouthwash for prevention of stomatitis in patients with breast cancer. METHODS: This US-based, multicentre, single-arm, phase 2 prevention study enrolled women aged 18 years and older with postmenopausal status who had histologically or cytologically confirmed metastatic hormone receptor-positive, HER2-negative breast cancer...
March 14, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/28287348/survival-in-idiopathic-pulmonary-fibrosis-perspectives-from-pulmonary-arterial-hypertension
#13
Toby M Maher, Fred Dejonckheere, Steven D Nathan
Maher has received grants, consulting fees, and speaker fees from GlaxoSmithKline and UCB and grants from Novartis. He has also received consulting fees and speaker fees from AstraZeneca, Bayer, Biogen Idec, Boehringer Ingelheim, Cipla, Lanthio, InterMune International AG (a wholly owned Roche subsidiary since 2014), F. Hoffmann-La Roche, Sanofi-Aventis, and Takeda. Maher is supported by a National Institute for Health Research Clinician Scientist Fellowship (NIHR Ref: CS:-2013-13-017). Dejonckheere is an employee of F...
March 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28287347/predicting-life-expectancy-for-pirfenidone-in-idiopathic-pulmonary-fibrosis
#14
Mark Fisher, Steven D Nathan, Christian Hill, Jade Marshall, Fred Dejonckheere, Per-Olof Thuresson, Toby M Maher
BACKGROUND: Conducting an adequately powered survival study in idiopathic pulmonary fibrosis (IPF) is challenging due to the rare nature of the disease and the need for extended follow-up. Consequently, registration trials of IPF treatments have not been designed to estimate long-term survival. OBJECTIVE: To predict life expectancy for patients with IPF receiving pirfenidone versus best supportive care (BSC) in a population that met the inclusion criteria of patients enrolled in the ASCEND and CAPACITY trials...
March 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28284557/binimetinib-versus-dacarbazine-in-patients-with-advanced-nras-mutant-melanoma-nemo-a-multicentre-open-label-randomised-phase-3-trial
#15
Reinhard Dummer, Dirk Schadendorf, Paolo A Ascierto, Ana Arance, Caroline Dutriaux, Anna Maria Di Giacomo, Piotr Rutkowski, Michele Del Vecchio, Ralf Gutzmer, Mario Mandala, Luc Thomas, Lev Demidov, Claus Garbe, David Hogg, Gabriella Liszkay, Paola Queirolo, Ernesto Wasserman, James Ford, Marine Weill, L Andres Sirulnik, Valentine Jehl, Viviana Bozón, Georgina V Long, Keith Flaherty
BACKGROUND: There are no established therapies specific for NRAS-mutant melanoma despite the emergence of immunotherapy. We aimed to assess the efficacy and safety of the MEK inhibitor binimetinib versus that of dacarbazine in patients with advanced NRAS-mutant melanoma. METHODS: NEMO is an ongoing, randomised, open-label phase 3 study done at 118 hospitals in 26 countries. Patients with advanced, unresectable, American Joint Committee on Cancer stage IIIC or stage IV NRAS-mutant melanoma who were previously untreated or had progressed on or after previous immunotherapy were randomised (2:1) to receive either binimetinib 45 mg orally twice daily or dacarbazine 1000 mg/m(2) intravenously every 3 weeks...
April 2017: Lancet Oncology
https://www.readbyqxmd.com/read/28273028/long-term-outcomes-of-imatinib-treatment-for-chronic-myeloid-leukemia
#16
RANDOMIZED CONTROLLED TRIAL
Andreas Hochhaus, Richard A Larson, François Guilhot, Jerald P Radich, Susan Branford, Timothy P Hughes, Michele Baccarani, Michael W Deininger, Francisco Cervantes, Satoko Fujihara, Christine-Elke Ortmann, Hans D Menssen, Hagop Kantarjian, Stephen G O'Brien, Brian J Druker
Background Imatinib, a selective BCR-ABL1 kinase inhibitor, improved the prognosis for patients with chronic myeloid leukemia (CML). We conducted efficacy and safety analyses on the basis of more than 10 years of follow-up in patients with CML who were treated with imatinib as initial therapy. Methods In this open-label, multicenter trial with crossover design, we randomly assigned patients with newly diagnosed CML in the chronic phase to receive either imatinib or interferon alfa plus cytarabine. Long-term analyses included overall survival, response to treatment, and serious adverse events...
March 9, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28268064/combination-of-dabrafenib-plus-trametinib-for-braf-and-mek-inhibitor-pretreated-patients-with-advanced-braf-v600-mutant-melanoma-an-open-label-single-arm-dual-centre-phase-2-clinical-trial
#17
Max Schreuer, Yanina Jansen, Simon Planken, Ines Chevolet, Teofila Seremet, Vibeke Kruse, Bart Neyns
BACKGROUND: Patients with BRAF(V600)-mutant melanoma benefit from treatment with the combination of BRAF and MEK inhibitors, but resistance and disease progression develops in most patients. Preclinical studies and case studies have indicated that acquired resistance to BRAF inhibition can be reversible. We aimed to assess the anti-tumour activity of rechallenge with BRAF plus MEK inhibition in a prospective clinical trial. METHODS: In this open-label, single arm, dual-centre, phase 2 academic study in Belgium, patients aged 18 years or older with BRAF(V600)-mutant melanoma who had previously progressed on BRAF inhibitors (with or without MEK inhibitors) and were off-treatment for at least 12 weeks, were treated with dabrafenib 150 mg orally twice per day plus trametinib 2 mg orally once per day...
April 2017: Lancet Oncology
https://www.readbyqxmd.com/read/28256832/allosteric-inactivation-of-polycomb-repressive-complex-2-prc2-by-inhibiting-its-adapter-protein-embryonic-ectodomain-development-eed
#18
Chao-Yie Yang, Shaomeng Wang
Aberrant PRC2 activity produces gene repressive epigenetic marks in multiple diseases and led to identification of Ezh2 as a drug target. Recent studies have shown that the epigenetic reader protein EED, associated with Ezh2 in PRC2, has an additional function to stimulate the PRC2 activity after binding to H3K27me3. Optimizing a compound known to block the H3K27me3 site in EED discovered by in-house screening, Novartis scientists have now produced a compound that shows durable tumor regression in a lymphoma xenograft model...
March 23, 2017: Journal of Medicinal Chemistry
https://www.readbyqxmd.com/read/28255254/ema401-an-old-antagonist-of-the-at2r-for-a-new-indication-in-neuropathic-pain
#19
Jan M Keppel Hesselink, Michael E Schatman
EMA401 is an old molecule, synthesized by Parke-Davis in the last century and characterized at that time as an AT2R antagonist. Professor Maree Smith and her group from the University of Queensland (Australia) patented the drug and many related derivatives and other compounds with high affinity for the AT2R for the indication neuropathic pain in 2004, an example of drug repositioning. After some years of university work, the Australian biotech company Spinifex Pharmaceuticals took over further research and development and characterized the S-enantiomer, code name EMA401, and related compounds in a variety of animal models for neuropathic and cancer pain...
2017: Journal of Pain Research
https://www.readbyqxmd.com/read/28230450/characteristics-and-medication-use-of-psoriasis-patients-who-may-or-may-not-qualify-for-randomized-controlled-trials
#20
William Malatestinic, Beth Nordstrom, Jashin J Wu, Orin Goldblum, Kathleen Solotkin, Chen-Yen Lin, Kristin Kistler, Kathy Fraeman, Joseph Johnston, Lcdr Lesley Hawley, Nicholas Sicignano, Andre Araujo
BACKGROUND: Clinical trials impose exclusion criteria that may limit the generalizability of results. OBJECTIVES: To (a) determine the percentage of real-world patients who would qualify for psoriasis randomized controlled trials; (b) ascertain differences between moderate-to-severe psoriasis patients who would be eligible, ineligible, or potentially eligible for clinical trials; and (c) compare their biologic treatment patterns. METHODS: Moderate-to-severe psoriasis patients were identified from the U...
March 2017: Journal of Managed Care & Specialty Pharmacy
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