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Kinase Inhibitor Screening In Self-assembled Human Protein Microarrays
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Zanubrutinib: First Approval.

Yahiya Y Syed1

  • 1Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. dru@adis.com.

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|January 15, 2020
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Summary
This summary is machine-generated.

Zanubrutinib, a Bruton tyrosine kinase (BTK) inhibitor, has gained accelerated US approval for treating mantle cell lymphoma (MCL). This oral medication offers a new option for adult patients with relapsed or refractory MCL.

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Area of Science:

  • Oncology
  • Pharmacology
  • Hematology

Background:

  • Zanubrutinib is an oral Bruton tyrosine kinase (BTK) inhibitor developed by BeiGene.
  • BTK inhibitors are a key class of drugs for treating B-cell malignancies.
  • Mantle cell lymphoma (MCL) is an aggressive B-cell non-Hodgkin lymphoma.

Purpose of the Study:

  • To summarize the development milestones of zanubrutinib.
  • To highlight the clinical data leading to its approval for MCL treatment.

Main Methods:

  • Review of clinical trial data (Phase II and I/II) for zanubrutinib in MCL.
  • Analysis of overall response rate (ORR) as the primary endpoint.

Main Results:

  • Zanubrutinib demonstrated significant overall response rates (ORR) in Phase II and I/II trials for MCL.
  • These results supported the accelerated approval.

Conclusions:

  • Zanubrutinib's development has led to a new therapeutic option for MCL patients.
  • The drug's efficacy, based on ORR, facilitated its expedited regulatory review and approval.