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Literature DB >> 31550019

Association Between FDA Label Restriction and Immunotherapy and Chemotherapy Use in Bladder Cancer.

Ravi B Parikh¹, Blythe J S Adamson², Sean Khozin³, Matthew D Galsky⁴, Shrujal S Baxi², Aaron Cohen², Ronac Mamtani¹.

Abstract

Entities: Disease

Mesh：

Substances：

Year: 2019 PMID： 31550019 PMCID： PMC6763996 DOI： 10.1001/jama.2019.10650

Source DB: PubMed Journal: JAMA ISSN： 0098-7484 Impact factor: 56.272

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6 in total

1. Fulfillment of Postmarketing Requirements to the FDA for Therapies Granted Oncology Indications Between 2011 and 2016.

Authors: Marjorie Zettler; Chadi Nabhan
Journal: JAMA Oncol Date: 2018-07-01 Impact factor: 31.777

Review 2. A 25-Year Experience of US Food and Drug Administration Accelerated Approval of Malignant Hematology and Oncology Drugs and Biologics: A Review.

Authors: Julia A Beaver; Lynn J Howie; Lorraine Pelosof; Tamy Kim; Jinzhong Liu; Kirsten B Goldberg; Rajeshwari Sridhara; Gideon M Blumenthal; Ann T Farrell; Patricia Keegan; Richard Pazdur; Paul G Kluetz
Journal: JAMA Oncol Date: 2018-06-01 Impact factor: 31.777

3. Speed of Adoption of Immune Checkpoint Inhibitors of Programmed Cell Death 1 Protein and Comparison of Patient Ages in Clinical Practice vs Pivotal Clinical Trials.

Authors: Jeremy M O'Connor; Kristen L Fessele; Jean Steiner; Kathi Seidl-Rathkopf; Kenneth R Carson; Nathan C Nussbaum; Emily S Yin; Kerin B Adelson; Carolyn J Presley; Anne C Chiang; Joseph S Ross; Amy P Abernethy; Cary P Gross
Journal: JAMA Oncol Date: 2018-08-09 Impact factor: 31.777

4. Atezolizumab as first-line treatment in cisplatin-ineligible patients with locally advanced and metastatic urothelial carcinoma: a single-arm, multicentre, phase 2 trial.

Authors: Arjun V Balar; Matthew D Galsky; Jonathan E Rosenberg; Thomas Powles; Daniel P Petrylak; Joaquim Bellmunt; Yohann Loriot; Andrea Necchi; Jean Hoffman-Censits; Jose Luis Perez-Gracia; Nancy A Dawson; Michiel S van der Heijden; Robert Dreicer; Sandy Srinivas; Margitta M Retz; Richard W Joseph; Alexandra Drakaki; Ulka N Vaishampayan; Srikala S Sridhar; David I Quinn; Ignacio Durán; David R Shaffer; Bernhard J Eigl; Petros D Grivas; Evan Y Yu; Shi Li; Edward E Kadel; Zachary Boyd; Richard Bourgon; Priti S Hegde; Sanjeev Mariathasan; AnnChristine Thåström; Oyewale O Abidoye; Gregg D Fine; Dean F Bajorin
Journal: Lancet Date: 2016-12-08 Impact factor: 79.321

5. First-line pembrolizumab in cisplatin-ineligible patients with locally advanced and unresectable or metastatic urothelial cancer (KEYNOTE-052): a multicentre, single-arm, phase 2 study.

Authors: Arjun V Balar; Daniel Castellano; Peter H O'Donnell; Petros Grivas; Jacqueline Vuky; Thomas Powles; Elizabeth R Plimack; Noah M Hahn; Ronald de Wit; Lei Pang; Mary J Savage; Rodolfo F Perini; Stephen M Keefe; Dean Bajorin; Joaquim Bellmunt
Journal: Lancet Oncol Date: 2017-09-26 Impact factor: 41.316

6. Development and Validation of a High-Quality Composite Real-World Mortality Endpoint.

Authors: Melissa D Curtis; Sandra D Griffith; Melisa Tucker; Michael D Taylor; William B Capra; Gillis Carrigan; Ben Holzman; Aracelis Z Torres; Paul You; Brandon Arnieri; Amy P Abernethy
Journal: Health Serv Res Date: 2018-05-14 Impact factor: 3.402

6 in total

8 in total

1. Homologous Recombination Related Signatures Predict Prognosis and Immunotherapy Response in Metastatic Urothelial Carcinoma.

Authors: Pan Li; Chaohu Chen; Jianpeng Li; Li Yang; Yuhan Wang; Zhilong Dong; Jun Mi; Yunxin Zhang; Juan Wang; Hanzhang Wang; Ronald Rodriguez; Junqiang Tian; Zhiping Wang
Journal: Front Genet Date: 2022-04-26 Impact factor: 4.772

2. Identification of a novel immune microenvironment signature predicting survival and therapeutic options for bladder cancer.

Authors: Yilin Yan; Zhengnan Huang; Jinming Cai; Pengfei Tang; Fang Zhang; Mingyue Tan; Bing Shen
Journal: Aging (Albany NY) Date: 2020-12-19 Impact factor: 5.682

Association Between FDA Label Restriction and Immunotherapy and Chemotherapy Use in Bladder Cancer.

1. Fulfillment of Postmarketing Requirements to the FDA for Therapies Granted Oncology Indications Between 2011 and 2016.

Review 2. A 25-Year Experience of US Food and Drug Administration Accelerated Approval of Malignant Hematology and Oncology Drugs and Biologics: A Review.

3. Speed of Adoption of Immune Checkpoint Inhibitors of Programmed Cell Death 1 Protein and Comparison of Patient Ages in Clinical Practice vs Pivotal Clinical Trials.

4. Atezolizumab as first-line treatment in cisplatin-ineligible patients with locally advanced and metastatic urothelial carcinoma: a single-arm, multicentre, phase 2 trial.

5. First-line pembrolizumab in cisplatin-ineligible patients with locally advanced and unresectable or metastatic urothelial cancer (KEYNOTE-052): a multicentre, single-arm, phase 2 study.

6. Development and Validation of a High-Quality Composite Real-World Mortality Endpoint.

1. Homologous Recombination Related Signatures Predict Prognosis and Immunotherapy Response in Metastatic Urothelial Carcinoma.

2. Identification of a novel immune microenvironment signature predicting survival and therapeutic options for bladder cancer.

3. Correlations between glycolysis with clinical traits and immune function in bladder urothelial carcinoma.

4. Immune Checkpoint Inhibitor Uptake in Real-World Patients With Malignant Pleural Mesothelioma.

5. MCM7 supports the stemness of bladder cancer stem-like cells by enhancing autophagic flux.

6. Impact of Label Restriction on Checkpoint-Inhibitor Use in Bladder Cancer and Changes in Mortality.

Review 7. Immune status for monitoring and treatment of bladder cancer.

8. DNA Repair Gene Mutations as Predictors of Immune Checkpoint Inhibitor Response beyond Tumor Mutation Burden.