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Related Experiment Video

Updated: May 3, 2026

Scaled-Up Preparation of an Intermediate of Upatinib, ACT051-3

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Published on: April 7, 2023

Ibrutinib: first global approval.

Fiona Cameron¹, Mark Sanford

¹Adis R & D Insight, 41 Centorian Drive, Private Bag 65901, Mairangi Bay, North Shore, 0754, Auckland, New Zealand, dru@adis.com.

|January 28, 2014

Summary

Ibrutinib is a novel oral medication targeting Bruton's tyrosine kinase, approved for mantle cell lymphoma. It shows promise in treating various B-cell malignancies by inhibiting malignant cell growth.

Area of Science:

Oncology
Pharmacology
Hematology

Background:

Ibrutinib is a first-in-class, orally available Bruton's tyrosine kinase inhibitor.
It targets B-cell malignancies, including chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL).

Purpose of the Study:

To summarize the development milestones of ibrutinib.
To highlight its first regulatory approval in MCL.

Main Methods:

Review of preclinical and clinical development data.
Analysis of regulatory submission and approval pathways.

Main Results:

Ibrutinib approved in the USA for previously treated MCL based on Phase Ib/II study.
Regulatory applications filed in the USA and EU for CLL/SLL.

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Ongoing Phase III trials for CLL/SLL, DLBCL, and MCL; Phase II for WM, FL, and MM.

Conclusions:

Ibrutinib represents a significant advancement in B-cell malignancy treatment.
Its development pathway highlights the FDA's Breakthrough Therapy Designation.