Your browser doesn't support javascript.
Mostrar: 20 | 50 | 100
Resultados 1 - 20 de 27.762
Filtrar
1.
Drugs Today (Barc) ; 55(9): 537-544, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31584571

RESUMO

On March 19, 2019, the United States Food and Drug Administration (FDA) approved Zulresso (brexanolone) for intravenous use for the treatment of postpartum depression (PPD) in adult women. The decision was based on three recent clinical trials following an FDA priority review and breakthrough therapy designation. Brexanolone is now available through a restricted process called the Zulresso Risk Evaluation and Mitigation Strategy Program that requires the drug to be administered by a healthcare provider in a certified healthcare facility. Brexanolone represents an important new treatment option to address treatment-resistant depressive symptoms. In this article, we discuss the current critical need for PPD treatments, the mechanisms of brexanolone action, and the efficacy and drug safety studies that led to FDA approval. Additionally, we discuss some limitations of the current formulation, specific populations of women that might benefit from this treatment, and how new drugs on the horizon may increase the ability to treat PPD in a variety of patient populations.


Assuntos
Depressão Pós-Parto/tratamento farmacológico , Pregnanolona/uso terapêutico , beta-Ciclodextrinas/uso terapêutico , Aprovação de Drogas , Combinação de Medicamentos , Feminino , Humanos , Estados Unidos , United States Food and Drug Administration
2.
Drugs Today (Barc) ; 55(9): 545-562, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31584572

RESUMO

On November 21, 2018, the U.S. Food and Drug Administration (FDA) approved glasdegib in combination with low-dose cytarabine (LDAC), for the treatment of newly diagnosed acute myeloid leukemia (AML) in patients > 75 years old or who have comorbidities that would be prohibitive of intensive induction chemotherapy. Glasdegib is a small-molecule inhibitor of a component of the hedgehog (HH) pathway, an upregulated pathway in leukemia and leukemia stem cells that is associated with relapse, drug resistance and poor survival. Preclinical studies suggested that glasdegib could sensitize AML cells to chemotherapy. FDA approval was based on a randomized, placebo-controlled, phase II trial in elderly or infirmed adults with new AML, unable to receive intensive induction chemotherapy, in whom the addition of glasdegib to LDAC nearly doubled the median overall survival compared with LDAC alone. In this report, we examine the preclinical development of glasdegib, its pharmacology and the clinical investigation that demonstrated its safety and efficacy, resulting in its approval. Additionally, we highlight ongoing investigation and future applications of this therapy.


Assuntos
Benzimidazóis/uso terapêutico , Leucemia Mieloide Aguda/tratamento farmacológico , Síndromes Mielodisplásicas/tratamento farmacológico , Compostos de Fenilureia/uso terapêutico , Idoso , Protocolos de Quimioterapia Combinada Antineoplásica , Ensaios Clínicos Fase II como Assunto , Citarabina , Aprovação de Drogas , Humanos , Quimioterapia de Indução , Ensaios Clínicos Controlados Aleatórios como Assunto , Estados Unidos , United States Food and Drug Administration
3.
Drugs Today (Barc) ; 55(9): 563-574, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31584573

RESUMO

The fixed-dose combination (FDC) of netarsudil 0.02%/ latanoprost 0.005% was approved by the United States Food and Drug Administration (FDA) on March 12, 2019, for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) and ocular hypertension (OHT). Netarsudil is a Rho kinase (ROCK) inhibitor and latanoprost is a prostaglandin analogue (PGA). Once-daily administration of this FDC reduces IOP by enhancing aqueous outflow through both the trabecular pathways (ROCK inhibition) and uveoscleral pathways (PGA). Two phase III clinical trials, MERCURY-1 and MERCURY-2, confirmed significantly greater efficacy of the FDC than the individual components, with IOP reductions of 30% or greater observed in 59-65% of subjects treated with FDC compared with 29-37% of subjects treated with latanoprost alone and 21-29% of subjects treated with netarsudil alone. The FDC was well tolerated with mostly mild ocular side effects and limited systemic side effects. This paper will review the work leading to FDA approval and the clinical indications for the use of this combination.


Assuntos
Benzoatos/uso terapêutico , Glaucoma de Ângulo Aberto/tratamento farmacológico , Latanoprosta/uso terapêutico , Hipertensão Ocular/tratamento farmacológico , beta-Alanina/análogos & derivados , Anti-Hipertensivos/uso terapêutico , Aprovação de Drogas , Quimioterapia Combinada , Humanos , Estados Unidos , United States Food and Drug Administration , beta-Alanina/uso terapêutico
4.
Drugs Today (Barc) ; 55(9): 575-585, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31584574

RESUMO

Patients with metastatic triple-negative breast cancer (mTNBC) that has progressed on first-line therapy have a poor prognosis with limited therapeutic options. Sacituzumab govitecan (SG) is a novel antibody-drug conjugate (ADC) that has shown promising efficacy in mTNBC. SG is comprised of SN-38, the active metabolite of irinotecan, conjugated via a hydrolyzable linker to the humanized RS7 antibody targeting trophoblast cell surface antigen 2 (Trop-2), a glycoprotein that is expressed at high levels in many epithelial solid tumors. It has received breakthrough therapy status by the U.S. Food and Drug Administration (FDA) for the treatment of patients with pretreated mTNBC. In this review, we summarize available data regarding the pharmacology, pharmacokinetics, safety and efficacy of SG and describe ongoing and future clinical studies investigating this agent.


Assuntos
Anticorpos Monoclonais Humanizados/uso terapêutico , Camptotecina/análogos & derivados , Imunoconjugados/uso terapêutico , Neoplasias de Mama Triplo Negativas/tratamento farmacológico , Antígenos de Neoplasias , Camptotecina/uso terapêutico , Moléculas de Adesão Celular , Feminino , Humanos , Estados Unidos , United States Food and Drug Administration
5.
Rinsho Ketsueki ; 60(9): 1108-1119, 2019.
Artigo em Japonês | MEDLINE | ID: mdl-31597834

RESUMO

Conventional chemotherapy with cytarabine and anthracycline (often referred to as "7+3") has been used for many years in the treatment of acute myeloid leukemia (AML). Despite meaningful advances in areas of supportive care and transplantation, little progress has been made in developing new chemotherapy options. In 2018, The Food and Drug Administration (FDA) of the US approved several novel agents for AML treatment as follows: ivosidenib, an inhibitor of isocitrate dehydrogenase-1; venetoclax, a potent inhibitor of bcl2; and glasdegib, an inhibitor of hedgehog signaling pathway. Moreover, clinical trials of alvocidib (flavopiridol), an inhibitor of the CDK9, pevonedistat, an inhibitor of NEDD8, and APR-246, a reactivator of mutant p53, are in progress. These agents will either be incorporated into the conventional 7+3 regimen or combined with hypomethylating agents to improve the outcome of AML therapy, and the results will guide the next stage of precision medicine in the treatment of AML.


Assuntos
Leucemia Mieloide Aguda/tratamento farmacológico , Benzimidazóis/uso terapêutico , Compostos Bicíclicos Heterocíclicos com Pontes/uso terapêutico , Ciclopentanos/farmacologia , Aprovação de Drogas , Flavonoides/farmacologia , Glicina/análogos & derivados , Glicina/uso terapêutico , Humanos , Terapia de Alvo Molecular , Compostos de Fenilureia/uso terapêutico , Piperidinas/farmacologia , Piridinas/uso terapêutico , Pirimidinas/farmacologia , Sulfonamidas/uso terapêutico , Estados Unidos , United States Food and Drug Administration
6.
MMWR Morb Mortal Wkly Rep ; 68(39): 839-844, 2019 Oct 04.
Artigo em Inglês | MEDLINE | ID: mdl-31581163

RESUMO

The 2009 Family Smoking Prevention and Tobacco Control Act prohibits the inclusion of characterizing flavors (e.g., candy or fruit) other than tobacco and menthol in cigarettes; however, characterizing flavors are not currently prohibited in other tobacco products at the federal level.* Flavored tobacco products can appeal to youths and young adults and influence initiation and establishment of tobacco-use patterns (1). The Food and Drug Administration (FDA) and CDC analyzed data from the 2014-2018 National Youth Tobacco Surveys (NYTS) to determine prevalence of current (past 30-day) use of flavored tobacco products, including electronic cigarettes (e-cigarettes), hookah tobacco, cigars, pipe tobacco, smokeless tobacco, bidis, and menthol cigarettes among U.S. middle school (grades 6-8) and high school (grades 9-12) students. In 2018, an estimated 3.15 million (64.1%) youth tobacco product users currently used one or more flavored tobacco products, compared with 3.26 million (70.0%) in 2014. Despite this overall decrease in use of flavored tobacco products, current use of flavored e-cigarettes increased among high school students during 2014-2018; among middle school students, current use of flavored e-cigarettes increased during 2015-2018, following a decrease during 2014-2015. During 2014-2018, current use of flavored hookah tobacco decreased among middle and high school students; current use of flavored smokeless tobacco, cigars, pipe tobacco, and menthol cigarettes decreased among high school students. Full implementation of comprehensive tobacco prevention and control strategies, coupled with regulation of tobacco products by FDA, can help prevent and reduce use of tobacco products, including flavored tobacco products, among U.S. youths (2,3).


Assuntos
Aromatizantes , Estudantes/psicologia , Produtos do Tabaco/estatística & dados numéricos , Uso de Tabaco/epidemiologia , Adolescente , Criança , Sistemas Eletrônicos de Liberação de Nicotina/estatística & dados numéricos , Feminino , Inquéritos Epidemiológicos , Humanos , Masculino , Prevalência , Instituições Acadêmicas/estatística & dados numéricos , Prevenção do Hábito de Fumar/legislação & jurisprudência , Estudantes/estatística & dados numéricos , Produtos do Tabaco/legislação & jurisprudência , Uso de Tabaco/legislação & jurisprudência , Uso de Tabaco/prevenção & controle , Tabaco sem Fumaça/estatística & dados numéricos , Estados Unidos/epidemiologia , United States Food and Drug Administration
8.
BMJ ; 367: l5766, 2019 10 23.
Artigo em Inglês | MEDLINE | ID: mdl-31645328

RESUMO

OBJECTIVE: To determine the extent to which late stage development of new drugs relies on support from public funding. DESIGN: Cohort study. SETTING: All new drugs containing one or more new molecular entities approved by the US Food and Drug Administration (FDA) between January 2008 and December 2017 via the new drug application pathway. MAIN OUTCOME MEASURES: Patents or drug development histories documenting late stage research contributions by a public sector research institution or a spin-off company, as well as each drug's regulatory approval pathway and first-in-class designation. RESULTS: Over the 10 year study period, the FDA approved 248 drugs containing one or more new molecular entities. Of these drugs, 48 (19%) had origins in publicly supported research and development and 14 (6%) originated in companies spun off from a publicly supported research program. Drugs in these groups were more likely to receive expedited FDA approval (68% v 47%, P=0.005) or be designated first in class (45% v 26%, P=0.007), indicating therapeutic importance. CONCLUSIONS: A review of the patents associated with new drugs approved over the past decade indicates that publicly supported research had a major role in the late stage development of at least one in four new drugs, either through direct funding of late stage research or through spin-off companies created from public sector research institutions. These findings could have implications for policy makers in determining fair prices and revenue flows for these products.


Assuntos
Ensaios Clínicos como Assunto/economia , Aprovação de Drogas/economia , Setor Público/economia , Pesquisa Médica Translacional/economia , Ensaios Clínicos como Assunto/estatística & dados numéricos , Estudos de Coortes , Aprovação de Drogas/legislação & jurisprudência , Aprovação de Drogas/estatística & dados numéricos , Humanos , Patentes como Assunto/estatística & dados numéricos , Setor Público/estatística & dados numéricos , Pesquisa Médica Translacional/estatística & dados numéricos , Estados Unidos , United States Food and Drug Administration/legislação & jurisprudência , United States Food and Drug Administration/estatística & dados numéricos
10.
Int J Pharm Compd ; 23(5): 428-433, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31513543

RESUMO

Compounding for veterinarians is regulated by the U.S. Food and Drug Administration, but day-to-day regulation is deferred to the state authorities. Veterinarians must meet certain standards when prescribing or dispensing a compounded medication. Veterinarians are expected to maintain current knowledge of the benefit of compounded preparations and prescribe and dispense in keeping with the best evidence related to animal and human health. Whether veterinarians recognize or adhere to these standards is unknown. A self-administered survey was distributed electronically to 30,000 email addresses on record with the Veterinary International Network. The survey asked questions about the regulations and standards associated with the use of or prescription of compounded medications. Of the distributed surveys, 1,520 survey responses were received, for a 5.1% response rate. All surveys were included in the final analysis. Respondents with a higher training level in compounding had a greater perceived skill level regarding compounding of medications (r = 0.26, P<0.0001). Similarly, respondents with a higher training level had a greater knowledge of state laws and regulations (r = 0.14, P<0.0001). Those with formal training had better scores on the assessment questions than those with informal or no training (P=0.01). Approximately one-third of the respondents felt that they were not knowledgeable at all about compounding rules and regulations. The most common compounded medications used in practice by veterinarians are methimazole, metronidazole, and doxycycline. Veterinarians mostly recognized that compounding backordered, commercially available products is permitted. Formal training improves familiarity with compounding rules, regulations, and current practices. Therefore, efforts should be directed at improving veterinary knowledge of laws and regulations surrounding the practice of compounding medications.


Assuntos
Metronidazol/farmacologia , Médicos Veterinários , Animais , Composição de Medicamentos/normas , Humanos , Metronidazol/química , Estados Unidos , United States Food and Drug Administration/normas
11.
Expert Opin Drug Saf ; 18(11): 1055-1063, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31500468

RESUMO

Introduction: Ciprofloxacin, levofloxacin, and moxifloxacin belong to the fluoroquinolone class of antibiotics and are amongst the most commonly prescribed antibiotics. In 2018 and 2019, Food and Drug Administration (FDA) and the European Medicine Agency (EMA) requested that manufacturers harmonize FQ safety information related to neuropsychiatric, aortic dissection, and long-term disability. The authors hypothesize that FDA and EMA epidemiologists support a strong association between these drugs and the three toxicities. Areas covered: Studies of FQ-associated neuropsychiatric toxicity, long-term disability, and aortic ruptures/dissections. Clinical sources include FDA Advisory Committee documents, a 2014 Citizen Petition filed with the FDA requesting safety information additions to FQ labels for neuropsychiatric toxicities (partially granted in 2018), an under-review Citizen Petition under review by the FDA requesting a FQ Risk Evaluation and Mitigation Strategy, and safety notifications from the EMA. Expert opinion: FDA and the EMA report state that neuropsychiatric toxicity, long-term disability, and aortic dissections//aneurysms occur with all FQs. Disability and neuropsychiatric toxicity can occur after one dose or several months after FQs. United States' and European' regulators warn physicians not to prescribe FQs for uncomplicated acute urinary tract infection, sinusitis, or bronchitis, unless other possible choices are tried first, as risks outweigh benefits in these settings.


Assuntos
Ciprofloxacino/efeitos adversos , Levofloxacino/efeitos adversos , Moxifloxacina/efeitos adversos , Aneurisma Dissecante/induzido quimicamente , Animais , Antibacterianos/administração & dosagem , Antibacterianos/efeitos adversos , Aneurisma Aórtico/induzido quimicamente , Ruptura Aórtica/induzido quimicamente , Ciprofloxacino/administração & dosagem , Avaliação da Deficiência , União Europeia , Humanos , Levofloxacino/administração & dosagem , Moxifloxacina/administração & dosagem , Síndromes Neurotóxicas/etiologia , Estados Unidos , United States Food and Drug Administration
12.
Expert Opin Drug Saf ; 18(11): 1077-1090, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31526195

RESUMO

Introduction: A radiation countermeasure that can be used prior to radiation exposure to protect the population from the harmful effects of radiation exposure remains a major unmet medical need and is recognized as an important area for research. Despite substantial advances in the research and development for finding nontoxic, safe, and effective prophylactic countermeasures for the acute radiation syndrome (ARS), no such agent has been approved by the United States Food and Drug Administration (FDA). Area covered: Despite the progress made to improve the effectiveness of amifostine as a radioprotector for ARS, none of the strategies have resolved the issue of its toxicity/side effects. Thus, the FDA has approved amifostine for limited clinical indications, but not for non-clinical uses. This article reviews recent strategies and progress that have been made to move forward this potentially useful countermeasure for ARS. Expert opinion: Although the recent investigations have been promising for fielding safe and effective radiation countermeasures, additional work is needed to improve and advance drug design and delivery strategies to get FDA approval for broadened, non-clinical use of amifostine during a radiological/nuclear scenario.


Assuntos
Síndrome Aguda da Radiação/tratamento farmacológico , Amifostina/administração & dosagem , Protetores contra Radiação/administração & dosagem , Amifostina/efeitos adversos , Animais , Aprovação de Drogas , Desenho de Drogas , Humanos , Protetores contra Radiação/efeitos adversos , Estados Unidos , United States Food and Drug Administration
14.
J Cosmet Sci ; 70(4): 181-196, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31441772

RESUMO

In the original scientific publication evaluating sunscreen methodologies, Garzarella and Caswell showed there to be no clinically significant or statistically significant difference in the average Sun Protection Factor (SPF) of a sunscreen formulation between any of three methodologies, Food and Drug Administration (FDA) Final Monograph, Australia/New Zealand, and European Cosmetics Association (COLIPA) International, suggesting that any differences in methodology were insignificant in the resulting SPF determined. These three major older methodologies have coalesced into two methodologies, 2011 FDA-Final Rule and ISO 24444, so that current sunscreen SPF testing is mostly 2011 FDA-Final Rule and ISO 24444. Another approach to evaluating the impact of methodological differences in sunscreen testing is to compare data on a control standard or reference sunscreen. If the difference between the two SPF values of P2 is statistically significant for the two different methodologies, then this would present evidence for a clinically significant difference in the SPF value between the two methodologies. For 2011 FDA-Final Rule, the expected SPF of P2 is 16.3 ± 3.43; for ISO 24444, the expected SPF of P2 is 16.1 ± 2.42. Using least squares average and standard error on 952 observations, the 2011 FDA-Final Rule SPF of P2 is 15.4 ± 0.12; using least squares average and standard error on 1,551 observations, the ISO 24444 SPF of P2 is 15.6 ± 0.10. The data described herein indicate no clinically significant nor statistically significant difference between the SPF average of P2 using the 2011 FDA-Final Rule methodology versus that using ISO 24444 methodology. Further statistical analysis indicates that the average SPF of P2 is independent of solar simulator type, time of year (month), age of subject, gender of subject, or Fitzpatrick Skin Phototype of subject. A statistically significant negative correlation was found between a subject's SPF of P2 and the subject's unprotected minimal erythemal dose. The implications of this relationship on SPF testing are explored.


Assuntos
Cosméticos , Fator de Proteção Solar , Humanos , Luz Solar , Protetores Solares , Raios Ultravioleta , Estados Unidos , United States Food and Drug Administration
16.
Stud Health Technol Inform ; 264: 883-887, 2019 Aug 21.
Artigo em Inglês | MEDLINE | ID: mdl-31438051

RESUMO

Patient safety events (PSEs), or medical errors, are major impediments to healthcare system safety. Health information technology (HIT) is expected to promote quality of care. Nonetheless, HIT also creates unintended consequences that concern patient safety consolidating a high-quality database of HIT events is essential to understanding their nature. Previous studies demonstrated the potential to use FDA Manufacturer and User Facility Device Experience (MAUDE) database to extract HIT events. In this study, we utilized classic and CNN models to extract HIT events from MAUDE. Both individual and combined models were evaluated on the test set, where the best model identified HIT events with ~90% accuracy and achieved a ~.87 f1 score. This model was capable of identifying HIT events in an HIT-exclusive database and serving as a quality and error check tool during event reporting. Moreover, the strategy of HIT event identification may scale in developing other PSE subtype-specific databases.


Assuntos
Informática Médica , Bases de Dados Factuais , Humanos , Segurança do Paciente , Relatório de Pesquisa , Estados Unidos , United States Food and Drug Administration
17.
Orthop Clin North Am ; 50(4): 415-423, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31466658

RESUMO

There is a growing interest in cell therapy for knee osteoarthritis. This study systematically reviews the current status of cell-based therapies. The authors review treatment modalities, clinical outcomes, and the economics of cell therapy. Inclusion criteria were articles containing cellular therapy, platelet-rich plasma, and knee osteoarthritis in the title. Letters, editorial material, abstracts not published, and manuscripts with incomplete data were excluded. Forty-two articles met these inclusion criteria and were critically reviewed. Cell-based therapy holds promise as a means of restoring deficient local cartilage cell populations. There is no evidence-based information for the use of cell-based therapies in knee osteoarthritis.


Assuntos
Terapia Baseada em Transplante de Células e Tecidos/economia , Terapia Baseada em Transplante de Células e Tecidos/métodos , Osteoartrite do Joelho/terapia , Terapia Baseada em Transplante de Células e Tecidos/normas , Análise Custo-Benefício , Política de Saúde , Humanos , Plasma Rico em Plaquetas/citologia , Ensaios Clínicos Controlados Aleatórios como Assunto , Transplante de Células-Tronco , Resultado do Tratamento , Estados Unidos , United States Food and Drug Administration
18.
MMWR Morb Mortal Wkly Rep ; 68(32): 703, 2019 Aug 16.
Artigo em Inglês | MEDLINE | ID: mdl-31415492

RESUMO

Lyme disease is a tickborne zoonosis for which serologic testing is the principal means of laboratory diagnosis. In 1994, the Association of State and Territorial Public Health Laboratory Directors, CDC, the Food and Drug Administration (FDA), the National Institutes of Health (NIH), the Council of State and Territorial Epidemiologists, and the National Committee for Clinical Laboratory Standards convened the Second National Conference on Serologic Diagnosis of Lyme Disease (1).


Assuntos
Doença de Lyme/diagnóstico , Testes Sorológicos/normas , Western Blotting , Centers for Disease Control and Prevention (U.S.) , Ensaio de Imunoadsorção Enzimática , Humanos , Doença de Lyme/sangue , Testes Sorológicos/métodos , Estados Unidos , United States Food and Drug Administration
19.
J Cancer Res Clin Oncol ; 145(9): 2303-2311, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31396700

RESUMO

BACKGROUND: Since 1997, several monoclonal antibodies (mAbs) targeting the same receptor or its ligand have been approved for use in oncology. However, no studies have summarized head-to-head trials of these mAbs. METHODS: Systematic search of the biomedical literature and ClinicalTrials.gov for randomized studies comparing mAbs targeting the same receptor or its ligand that have been completed and published, completed and unpublished, or ongoing. We extracted trial characteristics including phase, indication, enrollment or target enrollment, randomization, primary endpoint and sponsor. RESULTS: Twenty-two approved cancer mAbs had at least one other approved mAb targeting the same receptor or its ligand, totaling 41 different oncology indications. These include 5 anti-CD20 mAbs, 5 anti-PD1/PDL1 mAbs, 4 anti-HER2 mAbs, 3 anti-EGFR mAbs, 3 anti-VEGF mAbs and 2 anti-IL6/IL6R mAbs. Seventeen were completed and published and 14 were unpublished or ongoing trials. The completed and published trials enrolled 11,373 patients and tested 13 mAbs (13/22, 59%). Additionally, 13 (76%) contained drugs manufactured by the same company and 13 (76%) reached conclusions felt to be favorable to the sponsor. Of the 14 ongoing/completed unpublished trials, there is a total target enrollment of 3404 patients with 9 mAbs tested. Of these, 86% (12/14) are testing mAbs manufactured by the same company and 71% (10/14) are sponsored by the company that made the drug being tested. CONCLUSIONS: Most trials test drugs manufactured or sponsored by the same company. An overview of clinical trials agenda may lead to more uniform testing, helping clinicians make better evidence-informed prescribing decisions.


Assuntos
Anticorpos Monoclonais/uso terapêutico , Antineoplásicos Imunológicos/uso terapêutico , Ensaios Clínicos como Assunto/estatística & dados numéricos , Neoplasias/tratamento farmacológico , Ensaios Clínicos como Assunto/métodos , Aprovação de Drogas , Humanos , Neoplasias/epidemiologia , Estados Unidos/epidemiologia , United States Food and Drug Administration
20.
Drugs ; 79(12): 1287-1304, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31313099

RESUMO

Apoptosis, the process of programmed cell death, occurs normally during development and aging. Members of the B-cell lymphoma 2 (BCL2) family of proteins are central regulators of apoptosis, and resistance to apoptosis is one of the hallmarks of cancer. Targeting the apoptotic pathway via BCL2 inhibitors has been considered a promising treatment strategy in the past decade. Initial efforts with small molecule BH3 mimetics such as ABT-737 and ABT-263 (navitoclax) pioneered the development of the first-in-class Food and Drug Administration (FDA)-approved oral BCL2 inhibitor, venetoclax. Venetoclax was approved for the treatment of chronic lymphocytic leukemia and acute myeloid leukemia, and is now being studied in a number of hematologic malignancies. Several other inhibitors targeting different BCL2 family members are now in early stages of development.


Assuntos
Antineoplásicos/uso terapêutico , Neoplasias Hematológicas/tratamento farmacológico , Proteínas Proto-Oncogênicas c-bcl-2/antagonistas & inibidores , Compostos de Anilina/uso terapêutico , Apoptose/efeitos dos fármacos , Compostos de Bifenilo/uso terapêutico , Compostos Bicíclicos Heterocíclicos com Pontes/uso terapêutico , Aprovação de Drogas , Humanos , Leucemia Linfocítica Crônica de Células B/tratamento farmacológico , Terapia de Alvo Molecular , Nitrofenóis/uso terapêutico , Piperazinas/uso terapêutico , Proteínas Proto-Oncogênicas c-bcl-2/metabolismo , Sulfonamidas/uso terapêutico , Estados Unidos , United States Food and Drug Administration
SELEÇÃO DE REFERÊNCIAS
DETALHE DA PESQUISA