Medicamentos de actualidad. Drugs of today最新文献

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New product intros [ezetimibe/pitavastatin (new combination), ozoralizumab, ripasudil/brimonidine (new combination), spesolimab, valemetostat tosylate (first-in-class), valoctocogene roxaparvovec] 新产品推出[依折麦布/匹伐他汀(新组合),ozoralizumab,利帕舒地尔/溴莫那定(新组合),斯匹索利单抗,tosyate valemetostat(首创),valoccogene roxaparvovec]
Medicamentos de actualidad. Drugs of today Pub Date : 2023-01-01 DOI: 10.1358/dot.2023.59.1.3544242
{"title":"New product intros [ezetimibe/pitavastatin (new combination), ozoralizumab, ripasudil/brimonidine (new combination), spesolimab, valemetostat tosylate (first-in-class), valoctocogene roxaparvovec]","authors":"","doi":"10.1358/dot.2023.59.1.3544242","DOIUrl":"https://doi.org/10.1358/dot.2023.59.1.3544242","url":null,"abstract":"","PeriodicalId":85144,"journal":{"name":"Medicamentos de actualidad. Drugs of today","volume":"18 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"66459186","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Pamiparib for germline BRCA mutation-associated recurrent advanced ovarian, fallopian tube or primary peritoneal cancer. 种系BRCA突变相关复发性晚期卵巢癌、输卵管癌或原发性腹膜癌症的Pamiparib。
Medicamentos de actualidad. Drugs of today Pub Date : 2022-06-01 DOI: 10.1358/dot.2022.58.6.3389001
Anna Skrzypczyk-Ostaszewicz
{"title":"Pamiparib for germline BRCA mutation-associated recurrent advanced ovarian, fallopian tube or primary peritoneal cancer.","authors":"Anna Skrzypczyk-Ostaszewicz","doi":"10.1358/dot.2022.58.6.3389001","DOIUrl":"https://doi.org/10.1358/dot.2022.58.6.3389001","url":null,"abstract":"Epithelial ovarian cancers are gynecological malignancies with the poorest prognosis. Intensive research over the past few years has demonstrated ovarian cancer is a type of cancer in which new molecularly targeted drugs significantly affect patients' fate and prognosis. These drugs are poly [ADP-ribose] polymerase (PARP) inhibitors, which are used for maintenance treatment. These molecules continue to be intensively studied--their combination with other targeted therapies is carefully evaluated as more of them are discovered. Four PARP inhibitors have been approved by the U.S. Food and Drug Administration (FDA) so far. Olaparib, rucaparib and niraparib are approved for various indications in epithelial ovarian cancer, fallopian tube or primary peritoneal cancer, while the PARP inhibitors for the treatment of breast cancer are olaparib and talazoparib. Olaparib is also approved for the treatment of pancreatic cancer as well as prostate cancer, and rucaparib is also approved for prostate cancer. Pamiparib (Partruvix) is a new, selective inhibitor of PARP-1 and PARP-2 which was discovered by BeiGene Ltd. On April 30, 2021, pamiparib obtained its first registration worldwide--it was approved in China for the treatment of women with recurrent ovarian, fallopian tube or primary peritoneal cancer with confirmed germline BRCA mutation.","PeriodicalId":85144,"journal":{"name":"Medicamentos de actualidad. Drugs of today","volume":"58 6 1","pages":"299-309"},"PeriodicalIF":0.0,"publicationDate":"2022-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48598289","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Bimekizumab for psoriasis. 比美珠单抗治疗牛皮癣。
Medicamentos de actualidad. Drugs of today Pub Date : 2022-06-01 DOI: 10.1358/dot.2022.58.6.3400572
M. Rodrigues, Egídio Freitas, T. Torres
{"title":"Bimekizumab for psoriasis.","authors":"M. Rodrigues, Egídio Freitas, T. Torres","doi":"10.1358/dot.2022.58.6.3400572","DOIUrl":"https://doi.org/10.1358/dot.2022.58.6.3400572","url":null,"abstract":"Psoriasis is a chronic, immune-mediated, inflammatory skin disease, affecting 1% to 3% of the population in Western countries. Due to advances in the understanding of psoriasis pathogenesis, in particular, the role of the interleukin-23 (IL-23)/T-helper 17 (Th17) immune axis, highly effective, targeted biologic therapies have been developed, shifting the psoriasis treatment paradigm. However, some patients do not respond or lose response to these novel therapies. Bimekizumab is a first-in-class humanized monoclonal immunoglobulin G1 (IgG1) antibody that potently and selectively inhibits both IL-17A and IL-17F, functioning as a dual inhibitor. All bimekizumab studies have shown high efficacy in psoriasis patients. Its onset of response was rapid and sustained for periods up to 60 weeks. In active-comparator trials to date, bimekizumab was superior to adalimumab (BE SURE), ustekinumab (BE VIVID) and secukinumab (BE RADIANT). It has demonstrated a consistent safety profile and high tolerability. The most common adverse events were largely restricted to mucosal candidiasis. Dual inhibition of IL-17A and IL-17F with bimekizumab showed to be a highly effective treatment for psoriasis, and the product is already approved for treatment of moderate to severe plaque psoriasis in Europe, Canada and Japan.","PeriodicalId":85144,"journal":{"name":"Medicamentos de actualidad. Drugs of today","volume":"58 6 1","pages":"273-282"},"PeriodicalIF":0.0,"publicationDate":"2022-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46628622","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 1
Asparaginase Erwinia chrysanthemi for acute lymphoblastic leukemia and lymphoblastic lymphoma. 治疗急性淋巴母细胞白血病和淋巴母细胞淋巴瘤的天冬酰胺酶。
Medicamentos de actualidad. Drugs of today Pub Date : 2022-06-01 DOI: 10.1358/dot.2022.58.6.3413459
Congying Gao, Xiang-Yu Ma, Zifan Zhang, Q. Lu, C. Ashby, Liuya Wei, Zhe S Chen
{"title":"Asparaginase Erwinia chrysanthemi for acute lymphoblastic leukemia and lymphoblastic lymphoma.","authors":"Congying Gao, Xiang-Yu Ma, Zifan Zhang, Q. Lu, C. Ashby, Liuya Wei, Zhe S Chen","doi":"10.1358/dot.2022.58.6.3413459","DOIUrl":"https://doi.org/10.1358/dot.2022.58.6.3413459","url":null,"abstract":"Acute lymphoblastic leukemia (ALL) is a neoplastic disease characterized by the malignant proliferation of lymphoid cells in the blood and bone marrow. It accounts for approximately 75% of childhood leukemia. Lymphoblastic lymphoma (LBL) is a type of non-Hodgkin's lymphoma characterized by rapid growth and highly aggressive characteristics that occurs most commonly in adolescents and young adults. Asparaginase is primarily used to treat patients with ALL or LBL. Because allergic reactions occur in patients treated with bacterial-derived asparaginase, it is important to develop an alternative asparaginase preparation for patients allergic to asparaginase. Recombinant asparaginase Erwinia chrysanthemi-rywn (JZP-458) is a recombinant Erwinia asparaginase that uses a novel Pseudomonas fluorescens expression platform in the production process. JZP-458 has the same amino acid sequence as E. chrysanthemi-derived asparaginase (ERW) and its in vitro activity is similar to that of ERW. JZP-458 is highly efficacious in patients allergic to asparaginase. Data from a phase I clinical trial indicated that following the intramuscular or intravenous administration of JZP-458 to volunteers, serum asparaginase activity ≥ 0.1 IU/mL was observed in 100% of the volunteers 72 hours after administration. In this review, we summarize the mechanism of action and the related research data obtained with JZP-458 for the treatment of ALL or LBL.","PeriodicalId":85144,"journal":{"name":"Medicamentos de actualidad. Drugs of today","volume":"58 6 1","pages":"261-271"},"PeriodicalIF":0.0,"publicationDate":"2022-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41545457","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 2
Brexucabtagene autoleucel: a breakthrough in the treatment of mantle cell lymphoma. Brexucabtagene自体甲醇:治疗套细胞淋巴瘤的突破。
Medicamentos de actualidad. Drugs of today Pub Date : 2022-06-01 DOI: 10.1358/dot.2022.58.6.3378055
Anagha Deshpande, Yucai Wang, J. Muñoz, P. Jain
{"title":"Brexucabtagene autoleucel: a breakthrough in the treatment of mantle cell lymphoma.","authors":"Anagha Deshpande, Yucai Wang, J. Muñoz, P. Jain","doi":"10.1358/dot.2022.58.6.3378055","DOIUrl":"https://doi.org/10.1358/dot.2022.58.6.3378055","url":null,"abstract":"In July 2020, the U.S. Food and Drug Administration (FDA) approved brexucabtagene autoleucel (BA), the first anti-CD19 chimeric antigen receptor (CAR) T-cell therapy for the treatment of relapsed/refractory mantle cell lymphoma (MCL). The pivotal ZUMA-2 trial led to the approval of BA in patients who experienced relapsed disease on prior therapies (chemotherapy and/or Bruton tyrosine kinase [BTK] inhibitors). The FDA approval of BA was based on excellent responses with this therapy in highly refractory patients with MCL, who conventionally had poor outcomes. Longer follow-up data from the ZUMA-2 study have been presented at recent international meetings. As is common with other CAR T-cell therapies in lymphomas, the main toxicities of BA therapy included cytokine release syndrome (CRS), infections, cytopenias and CAR-associated neurotoxicity. In this review, we provide a summary of the data in the development of BA and its impact on MCL patient survival and future directions.","PeriodicalId":85144,"journal":{"name":"Medicamentos de actualidad. Drugs of today","volume":"58 6 1","pages":"283-298"},"PeriodicalIF":0.0,"publicationDate":"2022-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47788058","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 5
Belumosudil for chronic graft-versus-host disease. 白莫硫地尔治疗慢性移植物抗宿主病。
Medicamentos de actualidad. Drugs of today Pub Date : 2022-05-01 DOI: 10.1358/dot.2022.58.5.3400705
Breanna Taylor, J. Cohen, Jennifer Tejeda, T. Wang
{"title":"Belumosudil for chronic graft-versus-host disease.","authors":"Breanna Taylor, J. Cohen, Jennifer Tejeda, T. Wang","doi":"10.1358/dot.2022.58.5.3400705","DOIUrl":"https://doi.org/10.1358/dot.2022.58.5.3400705","url":null,"abstract":"Chronic graft-versus-host disease (cGvHD) is a multisystem disease that is diagnosed in up to 70% of patients following allogeneic hematopoietic cell transplantation. In cGvHD, the donor immune cells attack the patient's cells, resulting in inflammation and fibrosis in multiple tissues. cGvHD can affect almost any organ and is the major cause of morbidity and mortality in transplant survivors. Rho-associated coiled-coil-containing protein kinase (ROCK) is a signaling pathway that modulates inflammatory response and fibrotic processes and is dysregulated in autoimmune disorders. Many inhibitors targeting the ROCK pathway have been studied, but most lack isoform selectivity resulting in dose-limiting effects. Belumosudil mesylate is a selective oral ROCK2 inhibitor that has demonstrated safety and efficacy for cGvHD. It has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult and pediatric patients 12 years and older with cGvHD after failure of at least two prior lines of systemic therapy, becoming the first and only approved therapy targeting ROCK2. This review examines the preclinical and clinical studies leading to the first approval of the novel drug belumosudil for cGvHD.","PeriodicalId":85144,"journal":{"name":"Medicamentos de actualidad. Drugs of today","volume":"58 5 1","pages":"203-212"},"PeriodicalIF":0.0,"publicationDate":"2022-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45485880","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 2
Efficacy, safety and cost of gene therapy medicinal products in the U.S. and Europe. 美国和欧洲基因治疗药物的有效性、安全性和成本。
Medicamentos de actualidad. Drugs of today Pub Date : 2022-05-01 DOI: 10.1358/dot.2022.58.5.3331005
B. Balkhi
{"title":"Efficacy, safety and cost of gene therapy medicinal products in the U.S. and Europe.","authors":"B. Balkhi","doi":"10.1358/dot.2022.58.5.3331005","DOIUrl":"https://doi.org/10.1358/dot.2022.58.5.3331005","url":null,"abstract":"Gene or advanced therapy medicinal products (ATMPs) are evolving innovative products that have recently been attracting medical and healthcare attention. ATMPs are offering advanced techniques in treating certain conditions, including rare diseases. Meanwhile, the short- and long-term safety and efficacy of these products raise concerns. In this study, a comparative analysis of gene therapy medicinal products in the U.S. and E.U. was carried out to provide an overview of their efficacy and safety. Data up until 2019 were collected from the Food and Drug Administration (FDA) and European Medicines Agency (EMA) regarding approved gene therapy products. The FDA and EMA websites and published clinical trials were searched to extract the required information. A total of eight gene therapies were identified that had been approved in the U.S. and/or E.U. These products are approved to treat various health conditions in different populations. Their efficacy and safety were evaluated on the basis of completed and ongoing pivotal clinical trials. ATMPs offer potential management for genetic disorders and rare health conditions that are untreatable. However, one of the main concerns associated with these therapies is the small sample size that is included in the pivotal clinical trials. The uncertain efficacy, incomplete trials and serious adverse events could be challenges that make some of these products a last-line therapy.","PeriodicalId":85144,"journal":{"name":"Medicamentos de actualidad. Drugs of today","volume":"58 5 1","pages":"223-240"},"PeriodicalIF":0.0,"publicationDate":"2022-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44365392","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Drug Information Association (DIA) Europe - 34th Annual Meeting (March 29-31, 2022 - Brussels, Belgium/Virtual). 欧洲药品信息协会第34届年会(2022年3月29日至31日,比利时布鲁塞尔/虚拟)。
Medicamentos de actualidad. Drugs of today Pub Date : 2022-05-01 DOI: 10.1358/dot.2022.58.5.3437189
M. Tumminello
{"title":"Drug Information Association (DIA) Europe - 34th Annual Meeting (March 29-31, 2022 - Brussels, Belgium/Virtual).","authors":"M. Tumminello","doi":"10.1358/dot.2022.58.5.3437189","DOIUrl":"https://doi.org/10.1358/dot.2022.58.5.3437189","url":null,"abstract":"The Drug Information Association (DIA) Europe held its 2022 annual meeting as a hybrid event, both as an in-person meeting in Brussels, Belgium, and as a virtual meeting. Many topics were discussed during this 3-day meeting, including the lessons learnt from the first 5 years' experience of the PRIME (PRIority MEdicine) scheme, the benefits and tools of the Clinical Trials Regulation, the roadmap of the electronic product information, the implementation of the substance, product, organization and referentials (SPOR) management services, and how real-world data, real-world evidence and digital health tools are changing the way clinical trials and research are performed.","PeriodicalId":85144,"journal":{"name":"Medicamentos de actualidad. Drugs of today","volume":"58 5 1","pages":"249-255"},"PeriodicalIF":0.0,"publicationDate":"2022-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45741130","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Tisotumab vedotin for the treatment of cervical carcinoma. 替妥单抗维多汀治疗宫颈癌。
Medicamentos de actualidad. Drugs of today Pub Date : 2022-05-01 DOI: 10.1358/dot.2022.58.5.3400745
Xin Song, Ruyi Li, Hong-wei Wang, Peng Song, Wenjing Guo, Zhe S Chen
{"title":"Tisotumab vedotin for the treatment of cervical carcinoma.","authors":"Xin Song, Ruyi Li, Hong-wei Wang, Peng Song, Wenjing Guo, Zhe S Chen","doi":"10.1358/dot.2022.58.5.3400745","DOIUrl":"https://doi.org/10.1358/dot.2022.58.5.3400745","url":null,"abstract":"Cervical cancer is one of the most common gynecological malignancies. At present, cytotoxic chemotherapeutic drugs and immunotherapy are the main therapeutic options for recurrent and metastatic cervical cancer. Tisotumab vedotin is an antibody-drug conjugate (ADC) and a potential novel treatment for cervical carcinoma. Tisotumab vedotin targets tissue factor (TF), which is highly expressed on the surface of cervical cancer cells, by delivering the cytotoxic agent monomethyl auristatin E (MMAE) directly into tumor cells. Currently, the U.S. Food and Drug Administration (FDA) has approved tisotumab vedotin for the treatment of adult female patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. This article reviews the results of preclinical studies and clinical trials of tisotumab vedotin. The findings suggest that tisotumab vedotin can induce clinically significant and long-lasting remission with controllable and tolerable safety in the difficult-to-treat group of cervical cancer patients.","PeriodicalId":85144,"journal":{"name":"Medicamentos de actualidad. Drugs of today","volume":"58 5 1","pages":"213-222"},"PeriodicalIF":0.0,"publicationDate":"2022-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44536279","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 6
Fluticasone propionate as a potential treatment for COVID-19. 丙酸氟替卡松作为COVID-19的潜在治疗方法。
Medicamentos de actualidad. Drugs of today Pub Date : 2022-05-01 DOI: 10.1358/dot.2022.58.5.3381591
M. McCarthy
{"title":"Fluticasone propionate as a potential treatment for COVID-19.","authors":"M. McCarthy","doi":"10.1358/dot.2022.58.5.3381591","DOIUrl":"https://doi.org/10.1358/dot.2022.58.5.3381591","url":null,"abstract":"Outpatient treatment options for mild to moderate COVID-19 are severely limited. While many therapeutic options have been proposed, very few have demonstrated the appropriate safety and efficacy to warrant approval by national or international regulatory bodies. Monoclonal antibodies have been shown to decrease hospitalization in high-risk patients, but use remains limited due to challenges associated with both production and administration, and other treatment options are urgently needed. The anti-inflammatory drug fluticasone propionate has recently emerged as a potential outpatient treatment option, especially for those with newly diagnosed disease. This manuscript reviews what is known about fluticasone and looks ahead to examine how the drug may be used in the future to address the COVID-19 pandemic.","PeriodicalId":85144,"journal":{"name":"Medicamentos de actualidad. Drugs of today","volume":"58 5 1","pages":"241-247"},"PeriodicalIF":0.0,"publicationDate":"2022-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45082709","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 1
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