Please use this identifier to cite or link to this item:
https://observatorio.fm.usp.br/handle/OPI/36255
Full metadata record
DC Field | Value | Language |
---|---|---|
dc.contributor | Sistema FMUSP-HC: Faculdade de Medicina da Universidade de São Paulo (FMUSP) e Hospital das Clínicas da FMUSP | |
dc.contributor.author | RIBEIRO, Tatiane Bomfim | |
dc.contributor.author | RIBEIRO, Adalton | |
dc.contributor.author | RODRIGUES, Luiza de Oliveira | |
dc.contributor.author | HARADA, Guilherme | |
dc.contributor.author | NOBRE, Moacyr Roberto Cuce | |
dc.date.accessioned | 2020-06-01T15:01:36Z | - |
dc.date.available | 2020-06-01T15:01:36Z | - |
dc.date.issued | 2020 | |
dc.identifier.citation | INTERNATIONAL JOURNAL OF TECHNOLOGY ASSESSMENT IN HEALTH CARE, v.36, n.1, p.20-28, 2020 | |
dc.identifier.issn | 0266-4623 | |
dc.identifier.uri | https://observatorio.fm.usp.br/handle/OPI/36255 | - |
dc.description.abstract | Objective This paper aims to describe the clinical and regulatory aspects of new drugs and indications that were approved for lung, breast, prostate, and colorectal cancer, from 2016 to 2018, in order to provide health technology assessment trends in oncology. Methods Data were collected from the US Food and Drug Administration (FDA) online database for new medications and indications approved for the above-mentioned types of cancer. Data regarding clinical study characteristics and regulatory information were collected. Results From 2016 to 2018, 53 percent of the FDA approvals of new drugs and indications for the most incident cancers were for oral protein kinase inhibitor monotherapy for advanced lung cancer. Since 2018, four drugs were approved as tumor-agnostic therapies. A biomarker was included in 72 percent of indications, and 58 percent of approvals were for targeted therapies, potentially heralding an end to research into conventional cytotoxic agents. A special designation for faster approval was granted in 78 percent of new approvals. The majority of the studies were open label randomized controlled trials (RCTs) (44 percent), followed by blind RCTs, single-arm clinical trials, and cohort studies. Only 14 percent of studies used overall survival as the primary end point; the vast majority used surrogate end points, and did not use patient-important outcomes. Three biosimilars were approved in the period. Conclusion Advanced lung cancer therapy, mainly targeted drugs, accounted for 53 percent of approvals. Special designations for faster approval were used in 78 percent of FDA approvals, and four drugs were approved for tumor-agnostic treatment-a new form of approval. | eng |
dc.language.iso | eng | |
dc.publisher | CAMBRIDGE UNIV PRESS | eng |
dc.relation.ispartof | International Journal of Technology Assessment in Health Care | |
dc.rights | restrictedAccess | eng |
dc.subject | FDA | eng |
dc.subject | United States Food and Drug Administration | eng |
dc.subject | Drug approval | eng |
dc.subject | Cancer | eng |
dc.subject | Lung cancer | eng |
dc.subject | Breast cancer | eng |
dc.subject | Prostate cancer | eng |
dc.subject | Colorectal cancer | eng |
dc.subject.other | surrogate end-points | eng |
dc.subject.other | strength | eng |
dc.subject.other | oncology | eng |
dc.subject.other | association | eng |
dc.subject.other | survival | eng |
dc.title | US Food and Drug Administration anticancer drug approval trends from 2016 to 2018 for lung, colorectal, breast, and prostate cancer | eng |
dc.type | article | eng |
dc.rights.holder | Copyright CAMBRIDGE UNIV PRESS | eng |
dc.identifier.doi | 10.1017/S0266462319000813 | |
dc.identifier.pmid | 31775939 | |
dc.subject.wos | Health Care Sciences & Services | eng |
dc.subject.wos | Public, Environmental & Occupational Health | eng |
dc.subject.wos | Medical Informatics | eng |
dc.type.category | editorial material | eng |
dc.type.version | publishedVersion | eng |
hcfmusp.author.external | RIBEIRO, Adalton:Sao Paulo Hlth Dept, Sao Paulo, Brazil | |
hcfmusp.author.external | RODRIGUES, Luiza de Oliveira:UNIMED Belo Horizonte, Belo Horizonte, MG, Brazil | |
hcfmusp.description.articlenumber | PII S0266462319000813 | |
hcfmusp.description.beginpage | 20 | |
hcfmusp.description.endpage | 28 | |
hcfmusp.description.issue | 1 | |
hcfmusp.description.volume | 36 | |
hcfmusp.origem | WOS | |
hcfmusp.origem.id | WOS:000524943100005 | |
hcfmusp.origem.id | 2-s2.0-85082659089 | |
hcfmusp.publisher.city | NEW YORK | eng |
hcfmusp.publisher.country | USA | eng |
hcfmusp.relation.reference | Barlesi F, 2016, LANCET, V387, P1415, DOI 10.1016/S0140-6736(16)00004-0 | eng |
hcfmusp.relation.reference | Blumenthal GM, 2019, NAT REV CLIN ONCOL, V16, P139, DOI 10.1038/s41571-019-0170-z | eng |
hcfmusp.relation.reference | Bray F, 2018, CA-CANCER J CLIN, V68, P394, DOI 10.3322/caac.21492 | eng |
hcfmusp.relation.reference | CDER, 2014, CTR DRUG EV RES ADV | eng |
hcfmusp.relation.reference | Cornes P, 2012, TARGET ONCOL, V7, pS57, DOI 10.1007/s11523-011-0196-3 | eng |
hcfmusp.relation.reference | Davis C, 2017, BMJ-BRIT MED J, V359, DOI 10.1136/bmj.j4530 | eng |
hcfmusp.relation.reference | Dillon A, 2018, JAMA-J AM MED ASSOC, V319, P767, DOI 10.1001/jama.2017.20552 | eng |
hcfmusp.relation.reference | Eisenhauer EA, 2009, EUR J CANCER, V45, P228, DOI 10.1016/j.ejca.2008.10.026 | eng |
hcfmusp.relation.reference | FDA. Food and Drud Administration, 2018, CTR DRUG EV RES FRAM | eng |
hcfmusp.relation.reference | FDA. Food and Drug Administration, 2014, CTR DRUG EV RES GUID | eng |
hcfmusp.relation.reference | Global Oncology Trends, 2018, IQVIA I HUM DAT SCI | eng |
hcfmusp.relation.reference | Goring S, 2019, BMJ OPEN, V9, DOI 10.1136/bmjopen-2018-024895 | eng |
hcfmusp.relation.reference | Gyawali B, 2019, JAMA INTERN MED, V179, P906, DOI 10.1001/jamainternmed.2019.0462 | eng |
hcfmusp.relation.reference | Haslam A, 2019, EUR J CANCER, V106, P196, DOI 10.1016/j.ejca.2018.11.012 | eng |
hcfmusp.relation.reference | Jardim DL, 2016, ONCOTARGET, V7, P53037, DOI 10.18632/oncotarget.10588 | eng |
hcfmusp.relation.reference | Johnson JR, 2011, J NATL CANCER I, V103, P636, DOI 10.1093/jnci/djr062 | eng |
hcfmusp.relation.reference | Kim C, 2016, MAYO CLIN PROC, V91, P713, DOI 10.1016/j.mayocp.2016.02.012 | eng |
hcfmusp.relation.reference | Kinch MS, 2014, DRUG DISCOV TODAY, V19, P1831, DOI 10.1016/j.drudis.2014.08.007 | eng |
hcfmusp.relation.reference | Ladanie A, 2019, J CLIN EPIDEMIOL, V114, P49, DOI 10.1016/j.jclinepi.2019.05.033 | eng |
hcfmusp.relation.reference | Lemery S, 2017, NEW ENGL J MED, V377, P1409, DOI 10.1056/NEJMp1709968 | eng |
hcfmusp.relation.reference | Nabhan C, 2019, JAMA ONCOL, V5, P781, DOI 10.1001/jamaoncol.2019.0450 | eng |
hcfmusp.relation.reference | Prasad V, 2015, JAMA INTERN MED, V175, P1389, DOI 10.1001/jamainternmed.2015.2829 | eng |
hcfmusp.relation.reference | Salas-Vega S, 2017, JAMA ONCOL, V3, P382, DOI 10.1001/jamaoncol.2016.4166 | eng |
hcfmusp.relation.reference | Schleicher SM, 2017, JAMA ONCOL, V3, P989, DOI 10.1001/jamaoncol.2016.6789 | eng |
hcfmusp.relation.reference | Shen C, 2014, EXPERT REV PHARM OUT, V14, P45, DOI 10.1586/14737167.2014.868310 | eng |
hcfmusp.relation.reference | Siegel RL, 2017, CA-CANCER J CLIN, V67, P7, DOI 10.3322/caac.21387 | eng |
hcfmusp.relation.reference | Sun JC, 2017, BMC SYST BIOL, V11, P27, DOI 10.1186/s12918-017-0464-7 | eng |
hcfmusp.relation.reference | WHO, 2018, PRIC CANC MED ITS IM | eng |
dc.description.index | MEDLINE | eng |
dc.identifier.eissn | 1471-6348 | |
hcfmusp.citation.scopus | 13 | - |
hcfmusp.scopus.lastupdate | 2024-03-29 | - |
Appears in Collections: | Artigos e Materiais de Revistas Científicas - HC/ICESP Artigos e Materiais de Revistas Científicas - HC/InCor Artigos e Materiais de Revistas Científicas - ODS/03 |
Files in This Item:
File | Description | Size | Format | |
---|---|---|---|---|
art_RIBEIRO_US_Food_and_Drug_Administration_anticancer_drug_approval_2020.PDF Restricted Access | publishedVersion (English) | 194.63 kB | Adobe PDF | View/Open Request a copy |
Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.