FDA Approves Zanubrutinib for Mantle Cell Lymphoma

The FDA has approved zanubrutinib (Brukinsa, BeiGene) as a second-line treatment for patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.

Zanubrutinib is a small molecule inhibitor of Bruton’s tyrosine kinase, discovered by scientists at BeiGene, Ltd. Zanubrutinib and is taken as an oral capsule. 

“BTK inhibition is an established mode of treatment for patients with MCL, but many patients treated with previously-approved BTK inhibitors do not fully respond to BTK therapy or are forced to discontinue treatment early due to side effects,” said Luhua (Michael) Wang, MD, professor, Department of Lymphoma and Myeloma, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center, and clinical trial investigator, in a statement. “Today we have a new option for our adult patients who have received one prior systemic or targeted therapy and are living with MCL, an aggressive blood cancer that’s often diagnosed at a more advanced stage.”

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The recent approval is based upon efficacy results of two single-arm clinical trials with the primary endpoint being independent review committee (IRC)-assessed overall response rate (ORR) per 2013 Lugano Classification. Sum of complete responses and partial responses across both trials was 84%. 

In the Phase 2 trial of zanubrutinib in patients with relapsed or refractory MCL (NCT03206970):

• ORR: 84%

• Complete Response: 59%

• Partial Response: 24%

• Median duration of response: 19.5 months

• Median follow-up time: 18.4 months 

In the Global Phase 1/2  trial (NCT02343120):

• ORR: 84%

• Complete Response: 22%

• Partial Response: 64%

• Median duration of response: 18.5 months

• Median follow-up: 18.8 months 

Throughout the trials, 8 patients (7%) discontinued treatment due to adverse reaction development. The most common adverse reaction reported in the clinical trails included frequent cases of pneumonia. One patient reportedly experienced hepatitis B reactivation, resulting in dosage reduction, the official release says. 

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Warnings and Precautions issued with zanubrutinib’s prescribing information include: hemorrhages, infections (opportunistic), cytopenias, second primary malignancies, cardiac arrhythmias, and embryo-fetal toxicity. 

Adverse reactions reported with the use of zanubrutinib include neutrophil count decreased, platelet count decreased, upper respiratory tract infection, white blood cell count decreased, hemoglobin decreased, rash, bruising, diarrhea, and cough.

Zanubrutinib is also being evaluated in a global clinical program as a monotherapy in combination with other therapies to treat various B-cell malignancies. 

Full Prescribing Information