Complicated regulatory decision-making following inconsistent trial results: the issue with ibrutinib for mantle cell lymphoma

Edward R Scheffer Cliff^{1

2}, Talal Hilal³, Aaron S Kesselheim^{4

5}

Affiliations

¹ Program On Regulation, Therapeutics And Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA. ecliff@bwh.harvard.edu.
² Harvard Medical School, Boston, MA, USA. ecliff@bwh.harvard.edu.
³ Division of Hematology and Medical Oncology, Mayo Clinic, Phoenix, AZ, USA.
⁴ Program On Regulation, Therapeutics And Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA.
⁵ Harvard Medical School, Boston, MA, USA.

PMID: 37735523
DOI: 10.1038/s41571-023-00821-7

Complicated regulatory decision-making following inconsistent trial results: the issue with ibrutinib for mantle cell lymphoma

Edward R Scheffer Cliff et al. Nat Rev Clin Oncol. 2024 Jan.

. 2024 Jan;21(1):1-2.

doi: 10.1038/s41571-023-00821-7.

Authors

Edward R Scheffer Cliff^{1

2}, Talal Hilal³, Aaron S Kesselheim^{4

5}

Affiliations

¹ Program On Regulation, Therapeutics And Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA. ecliff@bwh.harvard.edu.
² Harvard Medical School, Boston, MA, USA. ecliff@bwh.harvard.edu.
³ Division of Hematology and Medical Oncology, Mayo Clinic, Phoenix, AZ, USA.
⁴ Program On Regulation, Therapeutics And Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA.
⁵ Harvard Medical School, Boston, MA, USA.

PMID: 37735523
DOI: 10.1038/s41571-023-00821-7

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References

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). - DOI - PubMed
1. 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). - DOI - PubMed - PMC
1. Wang, M. L. et al. Ibrutinib plus bendamustine and rituximab in untreated mantle-cell lymphoma. N. Engl. J. Med. 386, 2482–2494 (2022). - DOI - PubMed
1. 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). - DOI
1. AbbVie. Update on IMBRUVICA® (ibrutinib) U.S. Accelerated Approvals for Mantle Cell Lymphoma and Marginal Zone Lymphoma Indications (2023).

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Complicated regulatory decision-making following inconsistent trial results: the issue with ibrutinib for mantle cell lymphoma

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Complicated regulatory decision-making following inconsistent trial results: the issue with ibrutinib for mantle cell lymphoma

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