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FDA Approved Treatment

Vardhman Kumar, Shyni Varghese
The emergence of immunotherapies and recent FDA approval of several of them makes them a promising therapeutic strategy for cancer. While these advancements underscore the potential of engaging the immune system to target tumors, this approach has so far been efficient only for certain cancers. Extending immunotherapy as a widely acceptable treatment for various cancers requires a deeper understanding of the interactions of tumor cells within the tumor microenvironment (TME). The immune cells are a key component of the TME, which also includes other stromal cells, soluble factors, and extracellular matrix-based cues...
December 5, 2018: Advanced Healthcare Materials
Ali Mahdi, Behrad Darvishi, Keivan Majidzadeh-A, Malihe Salehi, Leila Farahmand
It is now fully recognized that along with multiple physiological functions, angiogenesis is also involved in the fundamental process and pathobiology of several disorders including cancer. Recent studies have fully established the role of angiogenesis in cancer progression as well as invasion and metastasis. Consequently, many therapeutic agents such as monoclonal antibodies targeting angiogenesis pathway have been introduced in clinic with the hope for improving the outcomes of cancer therapy. Bevacizumab (Avastin®) was the first anti-vascular endothelial growth factor (VEGF) targeting monoclonal antibody developed with this purpose and soon received its accelerated US Food and Drug Administration (FDA) approval for treatment of patients with metastatic breast cancer in 2008...
December 4, 2018: Journal of Cellular Physiology
Ryan P Werntz, Brittany Adamic, Gary D Steinberg
PURPOSE: BCG is the gold standard in management of high-risk non-muscle invasive bladder cancer (HRNMIBC). However, in patients who fail BCG, there are few effective intrasvesical options. This review aims to explore standard and emerging therapies in HRNMIBC. METHODS: A non-systematic literature review was performed using Medline and PubMed. Literature focused on HRNMIBC and BCG failure studies, with particular attention to Phase II and III clinical trials. RESULTS: The only FDA approved therapy for BCG failure patients in Valrubicin...
December 4, 2018: World Journal of Urology
Eric Nadler, Seongjung Joo, Marley Boyd, Jenny Black-Shinn, Diana Chirovsky
AIM: Cetuximab was approved in 2008 for treating recurrent/metastatic (R/M) head-and-neck squamous-cell carcinoma (HNSCC), and this study assessed the utilization of cetuximab for R/M-HNSCC in a real-world setting. MATERIALS & METHODS: Adult patients with R/M-HNSCC, who initiated systemic therapy between 1 September 2011 and  31 December 2014 and followed through 31 December 2015, were identified from iKnowMed electronic-health-records database (McKesson Specialty Health) supplemented with manual chart-abstraction...
December 4, 2018: Future Oncology
Lucas Gutierrez, Miran Jang, Tian Zhang, Mojtaba Akhtari, Houda Alachkar
Acute myeloid leukemia (AML) is a heterogeneous hematological malignancy in which the only curative approach is allogeneic stem cell transplant (Allo-HSCT). The recognition and elimination of leukemic clones by donor T-cells contribute significantly to Allo-HSCT success. FLT3-ITD, a common mutation in AML, is associated with poor prognosis. Recently, midostaurin became the first FDA approved FLT3-inhibitor for pre-transplant patients with FLT3-ITD in combination with standard therapy. In addition to their multikinase activity which may affect T-cell signaling, FLT3-inhibitors induce apoptosis of malignant cells which may also enhance antigen presentation to activate T-cells...
December 3, 2018: Scientific Reports
Robert Roskoski
Cyclins and cyclin-dependent protein kinases (CDKs) are important proteins that are required for the regulation and expression of the large number of components necessary for the passage through the cell cycle. The concentrations of the CDKs are generally constant, but their activities are controlled by the oscillation of the cyclin levels during each cell cycle. Additional CDK family members play significant roles in a wide range of activities including gene transcription, metabolism, and neuronal function...
November 30, 2018: Pharmacological Research: the Official Journal of the Italian Pharmacological Society
Shane Smith, John White, Kerollos Nashat Wanis, Andrew Beckett, Vivian C McAlister, Richard Hilsden
BACKGROUND: Junctional tourniquets have been incorporated into tactical combat casualty care for junctional vascular trauma. They apply external compression to stop blood flow in the groin and axilla. OBJECTIVES: The primary outcome was effectiveness in achieving arterial occlusion. Secondary outcomes included time to application and pain scores. DATA SOURCES: Medline and EMBASE databases were searched. STUDY APPRAISAL AND SYNTHESIS METHODS: A random effects meta-analysis was conducted to estimate the average effectiveness and time to effective application for each device...
November 30, 2018: Journal of Trauma and Acute Care Surgery
Matt Shirley
Dacomitinib (Vizimpro® ) is an orally administered, small-molecule irreversible inhibitor of HER1 (EGFR), HER2 and HER4 that was developed by Pfizer Inc. for the treatment of solid tumours. In September 2018, dacomitinib received its first global approval, in the USA, for use in the first-line treatment of patients with metastatic NSCLC with EGFR exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test. Registration applications for the use of dacomitinib as first-line treatment for patients with EGFR-mutation-positive metastatic NSCLC have also been submitted in the EU and Japan...
November 30, 2018: Drugs
Sheridan M Hoy
Talazoparib (TALZENNA™) is an oral inhibitor of the polyadenosine 5'-diphosphoribose polymerase (PARP) enzymes, which play a critical role in repairing DNA single-strand breaks. It has been developed by Pfizer and was recently approved in the USA for the treatment of adults with deleterious or suspected deleterious germline BRCA-mutated, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer (as detected by a US FDA-approved assay). A regulatory assessment for talazoparib in this patient population is underway in the EU, with talazoparib also undergoing development for use in metastatic castration-resistant prostate cancer and various solid tumours, and as neoadjuvant therapy in early triple negative breast cancer...
November 30, 2018: Drugs
Daichi Fujimoto, Daisuke Yamashita, Junya Fukuoka, Yuka Kitamura, Kazutaka Hosoya, Hayato Kawachi, Yuki Sato, Kazuma Nagata, Atsushi Nakagawa, Ryo Tachikawa, Naoki Date, Ichiro Sakanoue, Hiroshi Hamakawa, Yutaka Takahashi, Keisuke Tomii
BACKGROUND/AIM: While the PD-L1 22C3 pharmDx assay is an FDA-approved diagnostic assay for pembrolizumab use, not every pathology laboratory has the Dako Autostainer to use this assay. Since Ventana BenchMark platforms are more common, the Ventana SP263 assay can be used to inform treatment decisions involving nivolumab and pembrolizumab in non-small cell lung cancer (NSCLC). However, some studies have shown discordant results between the two assays. This study aimed was to compare PD-L1 expression using these two assays...
December 2018: Anticancer Research
Alex F Herrera
Genetic alterations of the PD-L1 / PD-L2 locus on chromosome 9p24.1 are a defining biological feature of classical Hodgkin lymphoma (HL). The resulting programmed death-ligand 1 (PD-L1) expression on Hodgkin Reed-Sternberg cells as well as the PD-L1 expressed in the HL microenvironment result in an ineffective host antitumor immune response and make HL a ripe target for programmed cell death-1 (PD-1) blockade. Anti-PD-1 antibody monotherapy has been effective and well tolerated in patients with relapsed or refractory (rel/ref) HL, with the majority of patients experiencing an objective response (approximately two-thirds of patients) and a median duration of response of 16...
November 30, 2018: Hematology—the Education Program of the American Society of Hematology
Scott C Brimley, Faysal A Yafi, Jacob Greenberg, Wayne J G Hellstrom, Hoang Minh Tue Nguyen, Georgios Hatzichristodoulou
INTRODUCTION: Peyronie's disease (PD) is a fibrotic disorder that leads to plaque formation in ∼3-9% of adult men. Connective tissue buildup results in plaque formation, penile curvature and shortening, and in some cases, pain. In the active phase of PD, penile pain is a common symptom, often accompanied by progression in curvature. Treatment options for PD include oral drugs, topical cream, intralesional injections, traction, and shock wave therapy. This article reviews the different treatment options for active-phase PD...
November 29, 2018: Sexual Medicine Reviews
Barbara Namer, Diana Schmidt, Esther Eberhardt, Michele Maroni, Eva Dorfmeister, Inge Petter Kleggetveit, Luisa Kaluza, Jannis Meents, Aaron Gerlach, Zhixin Lin, Andreas Winterpacht, Elena Dragicevic, Zacharias Kohl, Jürgen Schüttler, Ingo Kurth, Torhild Warncke, Ellen Jorum, Beate Winner, Angelika Lampert
BACKGROUND: Small fiber neuropathy (SFN) is a severe and disabling chronic pain syndrome with no causal and limited symptomatic treatment options. Mechanistically based individual treatment is not available. We report an in-vitro predicted individualized treatment success in one therapy-refractory Caucasian patient suffering from SFN for over ten years. METHODS: Intrinsic excitability of human induced pluripotent stem cell (iPSC) derived nociceptors from this patient and respective controls were recorded on multi-electrode (MEA) arrays, in the presence and absence of lacosamide...
November 28, 2018: EBioMedicine
Elizabeth M Sharis, Nicolas W Shammas, Gail A Shammas, Susan Jones-Miller
BACKGROUND: The WIRION EPS filter was recently approved by the Food and Drug Administration (FDA) to be used in conjunction with all atherectomy devices when treating infrainguinal peripheral arterial disease. The safety of this filter with Jetstream atherectomy (JA) in a real world setting remains unclear. METHODS: Consecutive patients from the practice of one operator who underwent JA under WIRION EPS when treating femoropopliteal arteries were enrolled in this retrospective analysis...
November 16, 2018: Cardiovascular Revascularization Medicine: Including Molecular Interventions
Masataka Majima, Yoshiya Ito, Kanako Hosono, Hideki Amano
Migraine is a severe neurological disorder in which calcitonin gene-related peptide (CGRP) is a key molecule in pathophysiology. Neuronal system-derived CGRP enhances neovascularization in several important pathological conditions and sends a cue to the vascular system. In 2018, the FDA approved erenumab and fremanezumab, antibodies against CGRP receptor and CGRP, as the first new class of drugs for migraine. Treatment of migraine with these antibodies requires great care because neovascularization-related adverse effects may be induced in some patients...
November 28, 2018: Trends in Pharmacological Sciences
Ning Wang, Panpan Qiu, Wei Cui, Bin Zhang, Xiaojun Yan, Shan He
Since the last century, when scientists proposed the lock-and-key model, the discovery of drugs has focused on the development of drugs acting on single target. However, single-target drug therapies are not effective to complex diseases with multi-factorial pathogenesis. Moreover, the combination of single-target drugs readily causes drug resistance and side effects. In recent years, multi-target drugs have increasingly been represented among FDA-approved drugs. Alzheimer's disease (AD) is a complex and multi-factorial disease for which the precise molecular mechanisms are still not fully understood...
December 3, 2018: Current Medicinal Chemistry
Robert Roskoski
The EGFR family is among the most investigated receptor protein-tyrosine kinase groups owing to its general role in signal transduction and in oncogenesis. This family consists of four members that belong to the ErbB lineage of proteins (ErbB1-4). The ErbB proteins function as homo and heterodimers. These receptors contain an extracellular domain that consists of four parts: domains I and III are leucine-rich segments that participate in growth factor binding (except for ErbB2) and domains II and IV contain multiple disulfide bonds...
November 27, 2018: Pharmacological Research: the Official Journal of the Italian Pharmacological Society
John Zhang, Zaher Merhi
Some of the common side effects of the injectable gonadotropins, used during fertility treatments, are pain at the injection site, skin erythema, muscle pain, and rarely vasovagal reflex. These side effects cause inconvenience and lower patient's tolerance for fertility treatments.The purpose of this study was to evaluate the safety and efficacy of an FDA-approved dose of nasal human menopausal gonadotropins (Menopur) in women undergoing fertility treatment. Healthy regularly cycling reproductive-aged women (n=4) with infertility were enrolled...
November 30, 2018: JBRA Assisted Reproduction
Jeffrey As Ritsema, Hessel van der Weide, Yvonne M Te Welscher, Wil Hf Goessens, Cornelus F van Nostrum, Gert Storm, Irma Ajm Bakker-Woudenberg, John P Hays
Respiratory tract infections are one of the most frequent infections worldwide, with an increasing number being associated with (multiple) antibiotic-resistant pathogens. Improved treatment requires the development of new therapeutic strategies, including the possible development of antibiotic-nanomedicines. Antibiotic-nanomedicines comprise antibiotic molecules coupled to nanocarriers via surface adsorption, surface attachment, entrapment or conjugation and can be administered via aerosolization. The efficacy and tolerability of this approach has been shown in clinical studies, with amikacin liposome inhalation suspension being the first inhalatory antibiotic-nanomedicine approved by the US FDA...
November 30, 2018: Future Microbiology
Samy Metyas, Christopher Tomassian, Ramy Messiah, Tina Gettas, Christina Chen, Anne Quismorio
Psoriasis is a chronic immune-mediated inflammatory dermatologic condition that is often associated with psoriatic arthritis. There are multiple regimens for the treatment of psoriasis including disease modifying anti rheumatics drugs, biologic agents, phototherapy, topical retinoid and steroids creams, as well as apremilast. Apremilast is an oral phosphodiesterase inhibitor that was approved by the FDA in March 2014 for the treatment of psoriatic arthritis and September 2014 for the treatment of moderate to severe plaque psoriasis...
November 29, 2018: Current Rheumatology Reviews
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