Dr. Rosenthal on FDA Approval of Ibrutinib in Marginal Zone Lymphoma

Allison C. Rosenthal, DO
Published: Thursday, Jan 19, 2017



Allison C. Rosenthal, DO, hematology consultant, Mayo Clinic, discusses the accelerated FDA approval of ibrutinib (Imbruvica) as a treatment for patients with advanced marginal zone lymphoma (MZL).

The approval for ibrutinib in MZL was based on findings from an open-label phase II study. The objective response rates with ibrutinib was 46%, with a complete response rate of 3.2%, according to findings presented at the 2016 ASH Annual Meeting. The median progression-free survival was 14.2 months with ibrutinib (95% CI, 8.3-NR) and the median overall survival was not yet reached at a median follow-up of 19.4 months.

The accelerated approval for MZL is contingent upon findings from a larger confirmatory study and helps to fill an unmet medical need for patients with MZL. Further studies will continue to assess the safety and efficacy of the BTK inhibitor for patients with MZL.


Allison C. Rosenthal, DO, hematology consultant, Mayo Clinic, discusses the accelerated FDA approval of ibrutinib (Imbruvica) as a treatment for patients with advanced marginal zone lymphoma (MZL).

The approval for ibrutinib in MZL was based on findings from an open-label phase II study. The objective response rates with ibrutinib was 46%, with a complete response rate of 3.2%, according to findings presented at the 2016 ASH Annual Meeting. The median progression-free survival was 14.2 months with ibrutinib (95% CI, 8.3-NR) and the median overall survival was not yet reached at a median follow-up of 19.4 months.

The accelerated approval for MZL is contingent upon findings from a larger confirmatory study and helps to fill an unmet medical need for patients with MZL. Further studies will continue to assess the safety and efficacy of the BTK inhibitor for patients with MZL.



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