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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 surv …
IMPORTANCE: The US Food and Drug Administration's (FDA's) accelerated approval pathway allows investigati …
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 su …
The Food and Drug Administration uses expedited approval of drugs to speed the development and assessment of …
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 acce …
IMPORTANCE: Numerous cancer drugs have received accelerated approval from the US Food and Drug Adm …
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 …
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 …
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.
However, single-arm trials that use surrogate endpoints (e.g., objective response rate or duration of response) to evaluate clinical benefit have become the basis for accelerated or breakthrough regulatory approval of precision oncology drugs fo …
However, single-arm trials that use surrogate endpoints (e.g., objective response rate or duration of response) to evaluate clinical …
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. Ladanie A, et al. JAMA Netw Open. 2020 Nov 2;3(11):e2024406. doi: 10.1001/jamanetworkopen.2020.24406. JAMA Netw Open. 2020. PMID: 33170262 Free PMC article.
IMPORTANCE: Clinical trial evidence used to support drug approval is typically the only information on benefits and harms that patients and clinicians can use for decision-making when novel cancer therapies become available. ...OBJECTIVE: To des …
IMPORTANCE: Clinical trial evidence used to support drug approval is typically the only information on benefits …
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. ...In fact, among ALK TKIs available, crizotinib was the first to receive FDA accelerate approval for ALK rearranged NSCLC patients. ...
Lung cancer still represents the leading cause of cancer-related mortality. ...In fact, among ALK TKIs available, crizotinib w …
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.
BACKGROUND: Most cancer drugs enter the US market first. US Food and Drug Administration (FDA) approvals of new cancer drugs may influence regulatory decisions in other settings. ...METHODS: All new FDA-approved cancer dr …
BACKGROUND: Most cancer drugs enter the US market first. US Food and Drug Administration (FDA) approvals of new …
FDA Approval Summary: Atezolizumab or Pembrolizumab for the Treatment of Patients with Advanced Urothelial Carcinoma Ineligible for Cisplatin-Containing Chemotherapy.
Suzman DL, Agrawal S, Ning YM, Maher VE, Fernandes LL, Karuri S, Tang S, Sridhara R, Schroeder J, Goldberg KB, Ibrahim A, McKee AE, Pazdur R, Beaver JA. Suzman DL, et al. Oncologist. 2019 Apr;24(4):563-569. doi: 10.1634/theoncologist.2018-0084. Epub 2018 Dec 12. Oncologist. 2019. PMID: 30541754 Free PMC article. Clinical Trial.
The U.S. Food and Drug Administration (FDA) granted accelerated approval to atezolizumab and pembrolizumab in April and May 2017, respectively, for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible …
The U.S. Food and Drug Administration (FDA) granted accelerated approval to atezolizumab and pembrolizumab in Ap …
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