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FDA Approved Treatment

Sheridan M Hoy
Tecovirimat (TPOXX® ) is an orthopoxvirus-specific antiviral drug developed by SIGA Technologies in conjunction with the US Department of Health and Human Services' Biomedical Advances Research and Development Authority. It acts by inhibiting the activity of the orthopoxvirus VP37 envelope wrapping protein, thereby preventing the formation of egress-competent enveloped virions, which are essential for dissemination of the virus in the host. In July 2018, oral tecovirimat was approved in the USA for the treatment of human smallpox disease caused by variola virus in adults and paediatric patients weighing ≥ 13 kg...
August 17, 2018: Drugs
Katherine C Pehlivan, Brynn B Duncan, Daniel W Lee
PURPOSE OF REVIEW: Genetically engineered T cells expressing a chimeric antigen receptor (CAR-T) targeting specific antigens present on acute lymphoblastic leukemia (ALL) blasts have generated promising results in children and adults with relapsed and refractory disease. We review the current evidence for CAR-T cell therapy in ALL, associated toxicities, and efforts to improve durable response to therapy. RECENT FINDINGS: CD19-directed CAR-T cells have recently been approved by the FDA for use in children and young adults with ALL and in adults with diffuse large B cell lymphoma (DLBCL) in the relapsed/refractory setting...
August 17, 2018: Current Hematologic Malignancy Reports
Jorge L Medina, Eliza A Sebastian, Andrea B Fourcaudot, Rossella Dorati, Kai P Leung
An inflammatory response is the normal response to a burn-induced injury. The burn-associated inflammation can lead to further tissue damage as the tissue tries to repair the damage. Prolonged or excessive inflammation is associated with increased fibrosis of burn wounds and the development of hypertrophic scars. The high incidence of hypertrophic scar formation is one of the many challenges to treating deep partial-thickness burns. Prophylactic treatment to improve burn-induced hypertrophic scarring is lacking...
August 17, 2018: Inflammation
Peter N Tsambarlis, Raymond Yong, Laurence A Levine
Collagenase clostridium histolyticum (CCH) was approved for the treatment of Peyronie's disease (PD) in December of 2013. Recently, further research has supported its use. The aim of this study was to objectively evaluate the effects of CCH on penile curvature associated with Peyronie's disease at our high volume institution. Since the approval of CCH for PD, 45 men have undergone between 1 and 4 treatment cycles (mean 3.13, standard deviation (SD) = 0.87) at our institution. Primary as well as secondary curvature, if any, was measured before beginning therapy and after each cycle of therapy...
August 17, 2018: International Journal of Impotence Research
Lola Fashoyin-Aje, Martha Donoghue, Huanyu Chen, Kun He, Janaki Veeraraghavan, Kirsten B Goldberg, Patricia Keegan, Amy E McKee, Richard Pazdur
On September 22, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval for pembrolizumab (Keytruda, Merck & Co., Inc., Whitehouse Station, NJ) for the treatment of patients with recurrent, locally advanced or metastatic, gastric or gastroesophageal junction (GEJ) adenocarcinoma with disease progression on or after two or more systemic therapies, including fluoropyrimidine- and platinum-containing chemotherapy and, if appropriate, HER2/neu-targeted therapy, and whose tumors express programmed death-ligand 1 (PD-L1), as determined by an FDA-approved test...
August 17, 2018: Oncologist
Patricia A Oneal, Virginia Kwitkowski, Lola Luo, Yuan Li Shen, Sriram Subramaniam, Stacy Shord, Kirsten B Goldberg, Amy E McKee, Edvardas Kaminskas, Ann Farrell, Richard Pazdur
On November 6, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to vemurafenib for the treatment of adult patients with Erdheim-Chester disease (ECD) with BRAF V600 mutation. ECD is a type of histiocytosis, a rare disorder characterized by an abnormal accumulation and behavior of cells of the mononuclear phagocytic system, which includes antigen-processing cells, dendritic cells, monocytes, or macrophages. Recently published data confirm a frequency of 54% of BRAF V600E mutations in patients with ECD...
August 17, 2018: Oncologist
Irene Ferrer, Álvaro Quintanal-Villalonga, Sonia Molina-Pinelo, Jose Manuel Garcia-Heredia, Marco Perez, Rocío Suárez, Santiago Ponce-Aix, Luis Paz-Ares, Amancio Carnero
BACKGROUND: The high incidence and mortality of lung tumours is a major health problem. Therefore, the identification both of biomarkers predicting efficacy for therapies in use and of novel efficacious therapeutic agents is crucial to increase patient survival. MAP17 (PDZK1IP1) is a small membrane-bound protein whose upregulation is reported as a common feature in tumours from diverse histological origins. Furthermore, MAP17 is correlated with tumour progression. METHODS: We assessed the expression of MAP17 in preclinical models, including cell lines and patient-derived xenografts (PDXs), assessing its correlation with sensitivity to different standard-of-care drugs in lung adenocarcinoma, as well as novel drugs...
August 17, 2018: Journal of Experimental & Clinical Cancer Research: CR
Icro Meattini, Isacco Desideri, Vieri Scotti, Gabriele Simontacchi, Lorenzo Livi
Ribociclib is a CDK4-6 inhibitor recently approved by the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) as first-line treatment for metastatic breast cancer (MBC). The pivotal trial showed a significant improvement in progression-free survival when compared to endocrine therapy alone. However, having a challenging toxicity profile in comparison with exclusive endocrine therapy, safety may be a concern when combined to radiotherapy (RT) with palliative approach. There are no available published data regarding the combination of ribociclib and palliative RT...
August 9, 2018: Breast: Official Journal of the European Society of Mastology
Robert Roskoski
The Ras-Raf-MEK-ERK signal transduction cascade is arguably the most important oncogenic pathway in human cancers. Ras-GTP promotes the formation of active homodimers or heterodimers of A-Raf, B-Raf, and C-Raf by an intricate process. These enzymes are protein-serine/threonine kinases that catalyze the phosphorylation and activation of MEK1 and MEK2 which, in turn, catalyze the phosphorylation and activation of ERK1 and ERK2. The latter catalyze the regulatory phosphorylation of dozens of cytosolic and nuclear proteins...
August 14, 2018: Pharmacological Research: the Official Journal of the Italian Pharmacological Society
Anna Berekmeri, Farrouq Mahmood, Miriam Wittmann, Philip Helliwell
Psoriasis and psoriatic arthritis (PsA) are inflammatory immune mediated conditions which can cause considerable disability and reduced quality of life. Management can be complex as clinical heterogeneity may lead to different treatment pathways. Tofacitinib is a novel, oral janus kinase (JAK) inhibitor with proven efficacy in rheumatoid arthritis. Areas covered: This review analyses recent studies of tofacitinib in psoriatic disease treatment. The relevant literature was identified using, PubMed and Google Scholar...
August 17, 2018: Expert Review of Clinical Immunology
Dan Le, Karen A Gelmon
Introduction Germline BRCA mutations (gBRCAm) are diagnosed in approximately 5% of unselected breast cancer patients. Olaparib is a new treatment option for patients with a gBRCAm who have metastatic HER2-negative breast cancer. Areas Covered Olaparib is an oral poly (ADP-ribose) polymerase inhibitor that has been shown in phase I-III clinical trials to have single-agent efficacy in breast cancer patients with gBRCAm. The recent phase III OlympiAD study demonstrated a statistically significant progression free survival benefit compared to the chemotherapy control arm, although an overall survival benefit has not been demonstrated...
August 17, 2018: Expert Review of Clinical Pharmacology
Daniel R McHugh, Calvin Utley Cotton, Fraser J Moss, Megan Vitko, Dana M Valerio, Thomas J Kelley, Shuyu Hao, Anjum Jafri, Mitchell L Drumm, Walter F Boron, Robert C Stern, Kimberly McBennett, Craig A Hodges
Gastrointestinal dysfunction in Cystic Fibrosis (CF) is a prominent source of pain among patients with CF. Linaclotide, a Guanylate Cyclase C (GCC) receptor agonist, is an FDA-approved drug prescribed for chronic constipation, but has not been widely utilized in CF, as the cystic fibrosis transmembrane conductance regulator (CFTR) is the main mechanism of action. However, anecdotal clinical evidence suggests that linaclotide may be effective for treating some gastrointestinal symptoms in CF. The goal of this study was to determine the effectiveness and mechanism of linaclotide in treating CF gastrointestinal disorders utilizing CF mouse models...
August 17, 2018: American Journal of Physiology. Gastrointestinal and Liver Physiology
Matt Shirley
Encorafenib (Braftovi™), a BRAF inhibitor, and binimetinib (Mektovi® ), a MEK inhibitor, are two orally bioavailable drugs developed by Array BioPharma. In June 2018 they each received their first global approval, in the USA, for use in combination, for patients with unresectable or metastatic melanoma with a BRAFV600E or -V600K mutation as detected by an FDA-approved test. Registration applications for encorafenib and binimetinib for use in combination in the treatment of BRAF-mutation-positive advanced melanoma have also been submitted in the EU, Australia, Switzerland and Japan, with the EMA Committee for Medicinal Products for Human Use adopting a positive opinion in July 2018 towards granting the drugs marketing authorizations in the EU...
August 16, 2018: Drugs
Ian A Jones, Ryan C Togashi, C Thomas Vangsness
PURPOSE OF REVIEW: This review provides an update on the current status of platelet-rich plasma (PRP). Topics covered include the current regulatory environment, economic outlook, and current clinical evidence. RECENT FINDINGS: The global PRP market is expected to grow to between 380 million and 4.5 billion (USD) over the next 5-10 years. The cost of a single treatment, which is not covered by most insurance, is roughly $500-$2500, with patients often returning for additional treatments...
August 16, 2018: Current Reviews in Musculoskeletal Medicine
Christie Hancock, Linda Green, Timothy Lestingi, Jacob Bitran Md
Objective We wanted to examine the incremental cost-effective ratio (ICER) for a variety of Food and Drug Administration (FDA) approved oncology drugs in the adjuvant or curative setting to determine the value provided. Design We examined the annualized incremental drug costs of a variety of FDA approved chemotherapeutic drugs used in an adjuvant or curative setting based on National Comprehensive Cancer Network (NCCN) category 1 practice guidelines for melanoma, Her2/neu over-expressive breast cancer, renal cell carcinoma, stage IIIA non-small cell lung cancer, myeloma, B cell lymphoma, and Hodgkin lymphoma...
June 14, 2018: Curēus
Kelly E McCann, Sara A Hurvitz
Poly-ADP-ribose polymerase 1 (PARP-1) and PARP-2 are DNA damage sensors that are most active during S-phase of the cell cycle and that have wider-reaching roles in DNA repair than originally described. BRCA1 and BRCA2 (Breast Cancer) proteins are involved in homologous recombination repair (HRR), which requires a homologous chromosome or sister chromatid as a template to faithfully repair DNA double-strand breaks. The small-molecule NAD+ mimetics, olaparib, niraparib, rucaparib, veliparib, and talazoparib, inhibit the catalytic activity of PARP-1 and PARP-2 and are currently being studied in later-stage clinical trials...
2018: Drugs in Context
Sigfred Ian R Alpajaro, Jerad A K Harris, Christopher P Evans
BACKGROUND: Non-metastatic castration resistant prostate cancer (M0CRPC) is a heterogenous disease state affecting an estimated 100,000 men in the United States. Development of more sensitive modalities for detection of metastasis has altered the landscape of advanced prostate cancer, but M0CRPC has remained a condition that previously lacked FDA-approved treatment. The emerging data on new generation Androgen Receptor (AR) pathway inhibitors should address this gap in the management of such patients...
August 16, 2018: Prostate Cancer and Prostatic Diseases
Michael P Saddoris, Kayla A Siletti, Katherine J Stansfield, Maria Florencia Bercum
Despite decades of research, investigations into effective neural and pharmacological therapies for many drugs of abuse, such as cocaine, have produced no FDA-approved approaches. This difficulty derives from the complexity of substance use disorders, which encompass a variety of behavioral, psychological, and neural circuit-based changes that occur as a result of repeated experience with the drug. Dopamine signaling has been demonstrated to play a key role in several aspects of drug abuse-from mediating its reinforcing properties and drug-seeking to triggering relapse-while also mediating a number of important aspects of normal (nondrug related) motivated behaviors and actions...
September 2018: Learning & Memory
Yvette L Kasamon, Chia-Wen Ko, Sriram Subramaniam, Lian Ma, Yuching Yang, Lei Nie, Stacy Shord, Donna Przepiorka, Ann T Farrell, Amy E McKee, Richard Pazdur
In April 2017, the U.S. Food and Drug Administration granted regular approval to midostaurin for the treatment of adult patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia (MCL). Approval was based on results from CPKC412D2201, a single-arm trial of midostaurin (100 mg orally twice daily) in previously treated or untreated patients. For the patients with ASM and SM-AHN, efficacy was established on the basis of confirmed complete remission (CR) plus incomplete remission (ICR) by modified Valent criteria with six cycles of midostaurin...
August 16, 2018: Oncologist
Deepti Chopra, Bharti Bhandari
Chronic hepatitis C remains a major public health concern with a prevalence of more than 1% worldwide. Of late, with the discovery of newer drugs, chronic HCV treatment has touched new dimensions. The treatment has progressed from Interferons to pegylated interferon (Peg IFN) based therapy, with or without ribavirin to treatment with orally active direct acting antivirals (DAA) with Peg IFN and ribavirin and eventually to various combinations of DAA, without IFN. Introduction of newer DAAs has transfigured the treatment of chronic HCV...
August 15, 2018: Infectious Disorders Drug Targets
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