364 related articles for article (PubMed ID: 26502403)
1. Cancer Drugs Approved on the Basis of a Surrogate End Point and Subsequent Overall Survival: An Analysis of 5 Years of US Food and Drug Administration Approvals.
Kim C; Prasad V
JAMA Intern Med; 2015 Dec; 175(12):1992-4. PubMed ID: 26502403
[No Abstract] [Full Text] [Related]
2. End points and United States Food and Drug Administration approval of oncology drugs.
Johnson JR; Williams G; Pazdur R
J Clin Oncol; 2003 Apr; 21(7):1404-11. PubMed ID: 12663734
[TBL] [Abstract][Full Text] [Related]
3. Ultimate fate of oncology drugs approved by the us food and drug administration without a randomized Trial.
Tsimberidou AM; Braiteh F; Stewart DJ; Kurzrock R
J Clin Oncol; 2009 Dec; 27(36):6243-50. PubMed ID: 19826112
[TBL] [Abstract][Full Text] [Related]
4. Assessing tumor-related signs and symptoms to support cancer drug approval.
Williams G; Pazdur R; Temple R
J Biopharm Stat; 2004 Feb; 14(1):5-21. PubMed ID: 15027497
[TBL] [Abstract][Full Text] [Related]
5. U.S. Food and Drug Administration anticancer drug approval trends from 2016 to 2018 for lung, colorectal, breast, and prostate cancer.
Ribeiro TB; Ribeiro A; Rodrigues LO; Harada G; Nobre MRC
Int J Technol Assess Health Care; 2020; 36(1):20-28. PubMed ID: 31775939
[TBL] [Abstract][Full Text] [Related]
6. Characteristics of clinical trials to support approval of orphan vs nonorphan drugs for cancer.
Kesselheim AS; Myers JA; Avorn J
JAMA; 2011 Jun; 305(22):2320-6. PubMed ID: 21642684
[TBL] [Abstract][Full Text] [Related]
7. Magnitude of Clinical Benefit of Cancer Drugs Approved by the US Food and Drug Administration Based on Single-Arm Trials.
Tibau A; Molto C; Borrell M; Del Paggio JC; Barnadas A; Booth CM; Amir E
JAMA Oncol; 2018 Nov; 4(11):1610-1611. PubMed ID: 30267037
[TBL] [Abstract][Full Text] [Related]
8. Meaningful endpoints for therapies approved for hematologic malignancies.
Smith BD; DeZern AE; Bastian AW; Durie BGM
Cancer; 2017 May; 123(10):1689-1694. PubMed ID: 28222220
[TBL] [Abstract][Full Text] [Related]
9. Clinically relevant end points and new drug approvals for myeloma.
Anderson KC; Kyle RA; Rajkumar SV; Stewart AK; Weber D; Richardson P;
Leukemia; 2008 Feb; 22(2):231-9. PubMed ID: 17972944
[TBL] [Abstract][Full Text] [Related]
10. Comparison of FDA accelerated vs regular pathway approvals for lung cancer treatments between 2006 and 2018.
Ribeiro TB; Buss L; Wayant C; Nobre MRC
PLoS One; 2020; 15(7):e0236345. PubMed ID: 32706800
[TBL] [Abstract][Full Text] [Related]
11. The US Food and Drug Administration's use of regular approval for cancer drugs based on single-arm studies: implications for subsequent evidence generation.
DeLoughery EP; Prasad V
Ann Oncol; 2018 Mar; 29(3):527-529. PubMed ID: 29346605
[No Abstract] [Full Text] [Related]
12. Anticancer Drugs Approved by the US Food and Drug Administration From 2009 to 2020 According to Their Mechanism of Action.
Olivier T; Haslam A; Prasad V
JAMA Netw Open; 2021 Dec; 4(12):e2138793. PubMed ID: 34905002
[TBL] [Abstract][Full Text] [Related]
13. A note on breast cancer trials with pCR-based accelerated approval.
Xia Y; Cui L; Yang B
J Biopharm Stat; 2014; 24(5):1102-14. PubMed ID: 24926729
[TBL] [Abstract][Full Text] [Related]
14. Response Rate as an Approval End Point in Oncology: Back to the Future.
Blumenthal GM; Pazdur R
JAMA Oncol; 2016 Jun; 2(6):780-1. PubMed ID: 26913938
[No Abstract] [Full Text] [Related]
15. Use of surrogate outcomes in US FDA drug approvals, 2003-2012: a survey.
Yu T; Hsu YJ; Fain KM; Boyd CM; Holbrook JT; Puhan MA
BMJ Open; 2015 Nov; 5(11):e007960. PubMed ID: 26614616
[TBL] [Abstract][Full Text] [Related]
16. Hurry up and wait: is accelerated approval of new cancer drugs in the best interests of cancer patients?
Schilsky RL
J Clin Oncol; 2003 Oct; 21(20):3718-20. PubMed ID: 12963701
[No Abstract] [Full Text] [Related]
17. Approvals in 2018: a histology-agnostic new molecular entity, novel end points and real-time review.
Blumenthal GM; Pazdur R
Nat Rev Clin Oncol; 2019 Mar; 16(3):139-141. PubMed ID: 30670830
[No Abstract] [Full Text] [Related]
18. Time from US Food and Drug Administration approval to publication of data for cancer drugs: a comparison of first and subsequent approvals.
Lammers A; Wang R; Cetnar J; Prasad V
Blood Cancer J; 2017 Nov; 7(12):637. PubMed ID: 29187747
[No Abstract] [Full Text] [Related]
19. Accelerated approval of oncology products: a decade of experience.
Dagher R; Johnson J; Williams G; Keegan P; Pazdur R
J Natl Cancer Inst; 2004 Oct; 96(20):1500-9. PubMed ID: 15494600
[TBL] [Abstract][Full Text] [Related]
20. Suggestions for Streamlining and Optimizing Clinical End-Point Bioequivalence Studies for US Abbreviated New Drug Application Submissions.
DiLiberti CE; Bon C; D'Angelo P; Gallicano K; Potvin D
Clin Pharmacol Ther; 2019 Feb; 105(2):310-312. PubMed ID: 30430559
[No Abstract] [Full Text] [Related]
[Next] [New Search]