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Assessment of the Clinical Benefit of Cancer Drugs Receiving Accelerated Approval.
Gyawali B, Hey SP, Kesselheim AS. Gyawali B, et al. JAMA Intern Med. 2019 Jul 1;179(7):906-913. doi: 10.1001/jamainternmed.2019.0462. JAMA Intern Med. 2019. PMID: 31135808 Free PMC article. Review.
IMPORTANCE: The US Food and Drug Administration's (FDA's) accelerated approval pathway allows investigational cancer drugs to be approved by demonstrating a beneficial effect on a surrogate measure (eg, progression-free survival) that is expecte …
IMPORTANCE: The US Food and Drug Administration's (FDA's) accelerated approval pathway allows investigational cancer …
Accelerated Approval Of Cancer Drugs: No Economic Reward For Drug Makers That Conduct Confirmatory Trials.
Frank RG, Shahzad M, Emanuel EJ. Frank RG, et al. Health Aff (Millwood). 2022 Sep;41(9):1273-1280. doi: 10.1377/hlthaff.2022.00119. Epub 2022 Aug 17. Health Aff (Millwood). 2022. PMID: 35977352
The Food and Drug Administration uses expedited approval of drugs to speed the development and assessment of drugs that address unmet needs related to serious or life-threatening conditions. Drugs approved via this route rely on surrogate …
The Food and Drug Administration uses expedited approval of drugs to speed the development and assessment of drugs …
Cancer drug indication approvals in China and the United States: a comparison of approval times and clinical benefit, 2001-2020.
Wei Y, Zhang Y, Xu Z, Wang G, Zhou Y, Li H, Shi L, Naci H, Wagner AK, Guan X. Wei Y, et al. Lancet Reg Health West Pac. 2024 Apr 2;45:101055. doi: 10.1016/j.lanwpc.2024.101055. eCollection 2024 Apr. Lancet Reg Health West Pac. 2024. PMID: 38590780 Free PMC article.
BACKGROUND: Perceived delays in cancer drug approvals have been a major concern for policymakers in China. Policies have been implemented to accelerate the launch of new cancer drugs and indications. This study aimed to assess similaritie …
BACKGROUND: Perceived delays in cancer drug approvals have been a major concern for policymakers in China. Policies have been …
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. Cherla A, et al. JAMA Intern Med. 2021 Apr 1;181(4):490-498. doi: 10.1001/jamainternmed.2020.8441. JAMA Intern Med. 2021. PMID: 33616607 Free PMC article.
IMPORTANCE: Numerous cancer drugs have received accelerated approval from the US Food and Drug Administration (FDA) based on clinical trial outcomes that are otherwise not acceptable for traditional FDA approval; the accelerated …
IMPORTANCE: Numerous cancer drugs have received accelerated approval from the US Food and Drug Administra …
ACCELERATE - Five years accelerating cancer drug development for children and adolescents.
Pearson ADJ, Weiner SL, Adamson PC, Karres D, Reaman G, Rousseau R, Blanc P, Norga K, Skolnik J, Kearns P, Scobie N, Barry E, Marshall LV, Knox L, Caron H, Wariabharaj D, Pappo A, DuBois SG, Gore L, Kieran M, Weigel B, Fox E, Nysom K, de Rojas T, Vassal G. Pearson ADJ, et al. Eur J Cancer. 2022 May;166:145-164. doi: 10.1016/j.ejca.2022.01.033. Epub 2022 Mar 12. Eur J Cancer. 2022. PMID: 35290915 Free article. Review.
Rapid evaluation and subsequent regulatory approval of new drugs are critical to improving survival and reducing long-term side-effects for children and adolescents with cancer. The international multi-stakeholder organisation ACCELERATE was created to …
Rapid evaluation and subsequent regulatory approval of new drugs are critical to improving survival and reducing long-term sid …
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. Chen EY, et al. JAMA Intern Med. 2019 Jul 1;179(7):915-921. doi: 10.1001/jamainternmed.2019.0583. JAMA Intern Med. 2019. PMID: 31135822 Free PMC article. Review.
MAIN OUTCOMES AND MEASURES: The primary outcome was the RR used as the basis for FDA approval. The secondary outcome was rate of complete response. RESULTS: Eighty-five indications for 59 cancer drugs were identified, 32 (38%) received regular appro …
MAIN OUTCOMES AND MEASURES: The primary outcome was the RR used as the basis for FDA approval. The secondary outcome was rate of comp …
Application of Real-World Data to External Control Groups in Oncology Clinical Trial Drug Development.
Yap TA, Jacobs I, Baumfeld Andre E, Lee LJ, Beaupre D, Azoulay L. Yap TA, et al. Front Oncol. 2022 Jan 6;11:695936. doi: 10.3389/fonc.2021.695936. eCollection 2021. Front Oncol. 2022. PMID: 35070951 Free PMC article. Review.
Randomized controlled trials (RCTs) that assess overall survival are considered the "gold standard" when evaluating the efficacy and safety of a new oncology intervention. However, single-arm trials that use surrogate endpoints (e.g., objective response rate or duration of …
Randomized controlled trials (RCTs) that assess overall survival are considered the "gold standard" when evaluating the efficacy and …
Marketing authorisation and pricing of FDA-approved cancer drugs in Brazil: a retrospective analysis.
Ivama-Brummell AM, Marciniuk FL, Wagner AK, Osorio-de-Castro CGS, Vogler S, Mossialos E, Tavares-de-Andrade CL, Naci H. Ivama-Brummell AM, et al. Lancet Reg Health Am. 2023 May 17;22:100506. doi: 10.1016/j.lana.2023.100506. eCollection 2023 Jun. Lancet Reg Health Am. 2023. PMID: 37235087 Free PMC article.
METHODS: All new FDA-approved cancer drugs from 2010 to 2019 were matched to drugs with MA and prices approved in Brazil by December 2020. ...INTERPRETATION: High-quality clinical evidence accelerated the availability of cancer …
METHODS: All new FDA-approved cancer drugs from 2010 to 2019 were matched to drugs with MA and prices approve …
Anaplastic lymphoma kinase tyrosine kinase inhibitors in non-small cell lung cancer.
Vavalà T, Mariniello A, Novello S. Vavalà T, et al. Transl Cancer Res. 2019 Jan;8(Suppl 1):S48-S54. doi: 10.21037/tcr.2018.10.23. Transl Cancer Res. 2019. PMID: 35117063 Free PMC article. Review.
Lung cancer still represents the leading cause of cancer-related mortality. However, the recent advent of tyrosine kinase inhibitors (TKI), pioneering drugs against targetable mutations, have dramatically improved prognosis of advanced non-small cell lung …
Lung cancer still represents the leading cause of cancer-related mortality. However, the recent advent of tyrosine kinase inhi …
Overall Survival in Phase 3 Clinical Trials and the Surveillance, Epidemiology, and End Results Database in Patients With Metastatic Colorectal Cancer, 1986-2016: A Systematic Review.
Shen C, Tannenbaum D, Horn R, Rogers J, Eng C, Zhou S, Johnson B, Kopetz S, Morris V, Overman M, Parseghian C, Chang GJ, Lopez-Olivo MA, Kanwal R, Ellis LM, Dasari A. Shen C, et al. JAMA Netw Open. 2022 May 2;5(5):e2213588. doi: 10.1001/jamanetworkopen.2022.13588. JAMA Netw Open. 2022. PMID: 35608860 Free PMC article.
Kaplan-Meier curves and log-rank tests were used to assess OS. FINDINGS: The literature search identified 150 phase III clinical trials with 77 494 total enrollments, and 67 126 patients with mCRC were identified from the SEER database. ...CONCLUSIONS AND RELEVANCE: …
Kaplan-Meier curves and log-rank tests were used to assess OS. FINDINGS: The literature search identified 150 phase III clinical …
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