Complicated regulatory decision-making following inconsistent trial results: the issue with ibrutinib for mantle cell lymphoma
Author:
Publisher
Springer Science and Business Media LLC
Subject
Oncology
Link
https://www.nature.com/articles/s41571-023-00821-7.pdf
Reference10 articles.
1. Gyawali, B., Ross, J. S. & Kesselheim, A. S. Fulfilling the mandate of the US Food and Drug Administration’s Accelerated Approval pathway: the need for reforms. JAMA Intern. Med. 181, 1275–1276 (2021).
2. Gyawali, B., Rome, B. N. & Kesselheim, A. S. Regulatory and clinical consequences of negative confirmatory trials of accelerated approval cancer drugs: retrospective observational study. BMJ 374, n1959 (2021).
3. Wang, M. L. et al. Ibrutinib plus bendamustine and rituximab in untreated mantle-cell lymphoma. N. Engl. J. Med. 386, 2482–2494 (2022).
4. Dreyling, M. et al. Efficacy and safety of ibrutinib combined with standard first-line treatment or as substitute for autologous stem cell transplantation in younger patients with mantle cell lymphoma: results from the randomized TRIANGLE trial by the European MCL Network. Blood 140 (Supplement 1), 1–3 (2022).
5. AbbVie. Update on IMBRUVICA® (ibrutinib) U.S. Accelerated Approvals for Mantle Cell Lymphoma and Marginal Zone Lymphoma Indications (2023).
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1. National Comprehensive Cancer Network Guideline Recommendations of Cancer Drugs With Accelerated Approval;JAMA Network Open;2023-11-14
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