Literature DB >> 33882220

"Dangling" Accelerated Approvals in Oncology.

Julia A Beaver1, Richard Pazdur1.   

Abstract

Year:  2021        PMID： 33882220     DOI： 10.1056/NEJMp2104846

Source DB:  PubMed          Journal:  N Engl J Med        ISSN： 0028-4793            Impact factor:   91.245


× No keyword cloud information.
  11 in total

1.  Epigenetic modifiers synergize with immune-checkpoint blockade to enhance long-lasting antitumor efficacy.

Authors:  Marina Baretti; Mark Yarchoan
Journal:  J Clin Invest       Date:  2021-08-16       Impact factor: 19.456

2.  Identification of threshold for large (dramatic) effects that would obviate randomized trials is not possible.

Authors:  Iztok Hozo; Benjamin Djulbegovic; Austin J Parish; John P A Ioannidis
Journal:  J Clin Epidemiol       Date:  2022-01-25       Impact factor: 7.407

Review 3.  U.S. FDA Drug Approvals for Breast Cancer: A Decade in Review.

Authors:  Shaily Arora; Preeti Narayan; Christy L Osgood; Suparna Wedam; Tatiana M Prowell; Jennifer J Gao; Mirat Shah; Danielle Krol; Sakar Wahby; Melanie Royce; Soma Ghosh; Reena Philip; Gwynn Ison; Tara Berman; Christina Brus; Erik W Bloomquist; Mallorie H Fiero; Shenghui Tang; Richard Pazdur; Amna Ibrahim; Laleh Amiri-Kordestani; Julia A Beaver
Journal:  Clin Cancer Res       Date:  2022-03-15       Impact factor: 13.801

4.  Evidence generation and reproducibility in cell and gene therapy research: A call to action.

Authors:  Mohamed Abou-El-Enein; Aris Angelis; Frederick R Appelbaum; Nancy C Andrews; Susan E Bates; Arlene S Bierman; Malcolm K Brenner; Marina Cavazzana; Michael A Caligiuri; Hans Clevers; Emer Cooke; George Q Daley; Victor J Dzau; Lee M Ellis; Harvey V Fineberg; Lawrence S B Goldstein; Stephen Gottschalk; Margaret A Hamburg; Donald E Ingber; Donald B Kohn; Adrian R Krainer; Marcela V Maus; Peter Marks; Christine L Mummery; Roderic I Pettigrew; Joni L Rutter; Sarah A Teichmann; Andre Terzic; Fyodor D Urnov; David A Williams; Jedd D Wolchok; Mark Lawler; Cameron J Turtle; Gerhard Bauer; John P A Ioannidis
Journal:  Mol Ther Methods Clin Dev       Date:  2021-07-21       Impact factor: 6.698

5.  FDA Accelerated Approval for Malignant Hematology and Oncology Indications in the Canadian Environment.

Authors:  Cheryl Ho; Howard J Lim; Dean A Regier
Journal:  Curr Oncol       Date:  2022-01-18       Impact factor: 3.677

6.  Small Cell Lung Cancer Transformation following Treatment in EGFR-Mutated Non-Small Cell Lung Cancer.

Authors:  Isa Mambetsariev; Leonidas Arvanitis; Jeremy Fricke; Rebecca Pharaon; Angel R Baroz; Michelle Afkhami; Marianna Koczywas; Erminia Massarelli; Ravi Salgia
Journal:  J Clin Med       Date:  2022-03-05       Impact factor: 4.241

7.  The Importance of and Challenges with Adopting Life-Cycle Regulation and Reimbursement in Canada.

Authors:  Melanie McPhail; Christopher McCabe; Dean A Regier; Tania Bubela
Journal:  Healthc Policy       Date:  2022-02

8.  Conditional Drug Approval as a Path to Market for Oncology Drugs in Canada: Challenges and Recommendations for Assessing Eligibility and Regulatory Responsiveness.

Authors:  Melanie McPhail; Emma Weiss; Tania Bubela
Journal:  Front Med (Lausanne)       Date:  2022-02-03

9.  Chemotherapy-induced COX-2 upregulation by cancer cells defines their inflammatory properties and limits the efficacy of chemoimmunotherapy combinations.

Authors:  Victoria S Pelly; Agrin Moeini; Shih-Chieh Chiang; Charlotte R Bell; Eimear Flanagan; Christian P Bromley; Christopher Clark; Charles H Earnshaw; Maria A Koufaki; Eduardo Bonavita; Santiago Zelenay
Journal:  Nat Commun       Date:  2022-04-19       Impact factor: 17.694

Review 10.  Analysis of FDA's Accelerated Approval Program Performance December 1992-December 2021.

Authors:  Ginny Beakes-Read; Madison Neisser; Patrick Frey; Mara Guarducci
Journal:  Ther Innov Regul Sci       Date:  2022-07-28       Impact factor: 1.337
View more

北京卡尤迪生物科技股份有限公司 © 2022-2023.