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Brukinsa FDA Approval History

Reviewed by J.Stewart BPharm. Last updated on Nov 19, 2019.

FDA Approved: Yes (First approved November 14, 2019)
Brand name: Brukinsa
Generic name: zanubrutinib
Dosage form: Capsules
Company: BeiGene, Ltd.
Treatment for: Mantle Cell Lymphoma

Brukinsa (zanubrutinib) is a Bruton’s tyrosine kinase (BTK) inhibitor indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.

  • Brukinsa was granted accelerated approval from the FDA based on overall response rate (ORR), and further clinical trials may be required to describe and verify the clinical benefits.
  • The approval of Brukinsa was based on efficacy results from two single-arm clinical trials, with ORR as the primary endpoint. Across both trials, 84% of patients treated with Brukinsa achieved complete or partial shrinkage of their tumors.
  • Brukinsa capsules are taken orally at a dosage of 160 mg twice daily, or 320 mg once daily. The capsules should be swallowed whole with water and can be taken with or without food.
  • Patients taking Brukinsa should be monitored for signs of hemorrhage, infections, cytopenias, second primary malignancies including skin cancers, and cardiac arrhythmias. Brukinsa can cause harm to a developing fetus, and women of childbearing potential should use effective contraception.
  • Common adverse reactions include decreased neutrophil count, decreased platelet count, upper respiratory tract infection, decreased white blood cell count, decreased hemoglobin, rash, bruising, diarrhea, and cough.

Development Timeline for Brukinsa

Nov 14, 2019ApprovalFDA Approves Brukinsa (zanubrutinib) for the Treatment of Mantle Cell Lymphoma
Aug 21, 2019BeiGene Announces U.S. FDA Acceptance and Grant of Priority Review for its New Drug Application of Zanubrutinib in Patients with Relapsed/Refractory Mantle Cell Lymphoma
Dec  1, 2018BeiGene Announces Clinical Results of Zanubrutinib in Mantle Cell Lymphoma From Two Presentations at the 60th American Society of Hematology Annual Meeting

Further information

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