200 related articles for article (PubMed ID: 37962889)
1. National Comprehensive Cancer Network Guideline Recommendations of Cancer Drugs With Accelerated Approval.
Cliff ERS; Rome RS; Kesselheim AS; Rome BN
JAMA Netw Open; 2023 Nov; 6(11):e2343285. PubMed ID: 37962889
[TBL] [Abstract][Full Text] [Related]
2. Characterization of accelerated approval status, trial endpoints and results, and recommendations in guidelines for oncology drug treatments from the National Comprehensive Cancer Network: cross sectional study.
Mooghali M; Mitchell AP; Skydel JJ; Ross JS; Wallach JD; Ramachandran R
BMJ Med; 2024; 3(1):e000802. PubMed ID: 38596814
[TBL] [Abstract][Full Text] [Related]
3. Regulatory and clinical consequences of negative confirmatory trials of accelerated approval cancer drugs: retrospective observational study.
Gyawali B; Rome BN; Kesselheim AS
BMJ; 2021 Sep; 374():n1959. PubMed ID: 34497044
[TBL] [Abstract][Full Text] [Related]
4. Frequency and level of evidence used in recommendations by the National Comprehensive Cancer Network guidelines beyond approvals of the US Food and Drug Administration: retrospective observational study.
Wagner J; Marquart J; Ruby J; Lammers A; Mailankody S; Kaestner V; Prasad V
BMJ; 2018 Mar; 360():k668. PubMed ID: 29514787
[TBL] [Abstract][Full Text] [Related]
5. Assessment of Coverage in England of Cancer Drugs Qualifying for US Food and Drug Administration Accelerated Approval.
Cherla A; Naci H; Kesselheim AS; Gyawali B; Mossialos E
JAMA Intern Med; 2021 Apr; 181(4):490-498. PubMed ID: 33616607
[TBL] [Abstract][Full Text] [Related]
6. National comprehensive cancer network recommendations for drugs without US food and drug administration approval in metastatic breast cancer: A cross-sectional study.
Etan T; Amir E; Tibau A; Yerushalmi R; Moore A; Shepshelovich D; Goldvaser H
Cancer Treat Rev; 2020 Dec; 91():102113. PubMed ID: 33128993
[TBL] [Abstract][Full Text] [Related]
7. Clinical Benefit and Regulatory Outcomes of Cancer Drugs Receiving Accelerated Approval.
Liu ITT; Kesselheim AS; Cliff ERS
JAMA; 2024 May; 331(17):1471-1479. PubMed ID: 38583175
[TBL] [Abstract][Full Text] [Related]
8. Level of evidence used in recommendations by the National Comprehensive Cancer Network (NCCN) guidelines beyond Food and Drug Administration approvals.
Kurzrock R; Gurski LA; Carlson RW; Ettinger DS; Horwitz SM; Kumar SK; Million L; von Mehren M; Benson AB
Ann Oncol; 2019 Oct; 30(10):1647-1652. PubMed ID: 31373348
[TBL] [Abstract][Full Text] [Related]
9. US Food and Drug Administration Accelerated Approval Program for Nononcology Drug Indications Between 1992 and 2018.
Omae K; Onishi A; Sahker E; Furukawa TA
JAMA Netw Open; 2022 Sep; 5(9):e2230973. PubMed ID: 36083581
[TBL] [Abstract][Full Text] [Related]
10. An Overview of Cancer Drugs Approved by the US Food and Drug Administration Based on the Surrogate End Point of Response Rate.
Chen EY; Raghunathan V; Prasad V
JAMA Intern Med; 2019 Jul; 179(7):915-921. PubMed ID: 31135822
[TBL] [Abstract][Full Text] [Related]
11. Approval of Cancer Drugs With Uncertain Therapeutic Value: A Comparison of Regulatory Decisions in Europe and the United States.
Salcher-Konrad M; Naci H; Davis C
Milbank Q; 2020 Dec; 98(4):1219-1256. PubMed ID: 33021339
[TBL] [Abstract][Full Text] [Related]
12. Spending by the Centers for Medicare & Medicaid Services Before and After Confirmation of Benefit for Drugs Granted US Food and Drug Administration Accelerated Approval, 2012 to 2017.
Skydel JJ; Egilman AC; Wallach JD; Ramachandran R; Gupta R; Ross JS
JAMA Health Forum; 2022 May; 3(5):e221158. PubMed ID: 35977252
[TBL] [Abstract][Full Text] [Related]
13. Increasing FDA-accelerated approval of single-arm trials in oncology (1992 to 2020).
Ribeiro TB; Bennett CL; Colunga-Lozano LE; Araujo APV; Hozo I; Djulbegovic B
J Clin Epidemiol; 2023 Jul; 159():151-158. PubMed ID: 37037322
[TBL] [Abstract][Full Text] [Related]
14. Therapeutic Value of Drugs Granted Accelerated Approval or Conditional Marketing Authorization in the US and Europe From 2007 to 2021.
Vokinger KN; Kesselheim AS; Glaus CEG; Hwang TJ
JAMA Health Forum; 2022 Aug; 3(8):e222685. PubMed ID: 36200635
[TBL] [Abstract][Full Text] [Related]
15. Assessment of the Clinical Benefit of Cancer Drugs Receiving Accelerated Approval.
Gyawali B; Hey SP; Kesselheim AS
JAMA Intern Med; 2019 Jul; 179(7):906-913. PubMed ID: 31135808
[TBL] [Abstract][Full Text] [Related]
16. Initial and supplementary indication approval of new targeted cancer drugs by the FDA, EMA, Health Canada, and TGA.
Michaeli DT; Mills M; Michaeli T; Miracolo A; Kanavos P
Invest New Drugs; 2022 Aug; 40(4):798-809. PubMed ID: 35389145
[TBL] [Abstract][Full Text] [Related]
17. Characteristics of Preapproval and Postapproval Studies for Drugs Granted Accelerated Approval by the US Food and Drug Administration.
Naci H; Smalley KR; Kesselheim AS
JAMA; 2017 Aug; 318(7):626-636. PubMed ID: 28810023
[TBL] [Abstract][Full Text] [Related]
18. Clinical Trial Evidence Supporting US Food and Drug Administration Approval of Novel Cancer Therapies Between 2000 and 2016.
Ladanie A; Schmitt AM; Speich B; Naudet F; Agarwal A; Pereira TV; Sclafani F; Herbrand AK; Briel M; Martin-Liberal J; Schmid T; Ewald H; Ioannidis JPA; Bucher HC; Kasenda B; Hemkens LG
JAMA Netw Open; 2020 Nov; 3(11):e2024406. PubMed ID: 33170262
[TBL] [Abstract][Full Text] [Related]
19. An estimate of rate of deviation from NCCN guideline recommendations for central nervous system imaging in trials forming basis for drug approval in first line advanced non-small cell lung cancer (NSCLC).
Sharp J; Prasad V
BMC Cancer; 2022 Jan; 22(1):70. PubMed ID: 35034621
[TBL] [Abstract][Full Text] [Related]
20. Cancer Drug Approvals That Displaced Existing Standard-of-Care Therapies, 2016-2021.
Benjamin DJ; Xu A; Lythgoe MP; Prasad V
JAMA Netw Open; 2022 Mar; 5(3):e222265. PubMed ID: 35289858
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]
