Updated
November 25th, 2019

FDA Grants Accelerated Approval For Treat Mantle Cell Lymphoma Treatment

BeiGene Ltd BRUKINSA is a BTK inhibitor that was designed to maximize target occupancy and minimize off-target binding

celebrating the fda approval

A Chinese company announced that BRUKINSA™ (zanubrutinib) has received accelerated approval from the United States Food and Drug Administration (FDA) as a treatment for mantle cell lymphoma (MCL) in adult patients, who have received at least one prior therapy.

This is an important FDA approval since Mantle Cell lymphoma is typically an aggressive, rare, form of non-Hodgkin lymphoma (NHL) that arises from cells originating in the “mantle zone.” MCL accounts for about 6 percent of all NHL cases in the United States.

Lymphoma is a diverse group of cancers that originate from B-, T- or NK- cells says the Lymphoma Research Association.

BeiGene, Ltd.’s BRUKINSA was approved to treat adult patients with MCL who have received at least one prior therapy on November 14, 2019.

BRUKINSA is not approved for use outside the United States.

This FDA accelerated approval is based on the overall response rate (ORR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial.

“BRUKINSA is a BTK inhibitor that was designed to maximize target occupancy and minimize off-target binding. It entered the clinic in 2014 and since that time our broad development program has enrolled more than 1,600 patients globally,” said Jane Huang, M.D., Chief Medical Officer, Hematology at BeiGene, in a November 14, 2019, press release.

“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, M.D., Professor, Department of Lymphoma and Myeloma, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center, and clinical trial investigator.

“The approval of BRUKINSA as a second-line therapy represents an important advancement for the treatment of mantle cell lymphoma,” said Meghan Gutierrez, Chief Executive Officer for the Lymphoma Research Foundation. “Expanded treatment options can transform the patient experience and provide hope to people living with a mantle cell diagnosis," continued Dr. Wang.

The FDA’s approval of BRUKINSA is based on efficacy results from two single-arm clinical trials, with independent review committee (IRC)-assessed ORR per 2014 Lugano Classification as the primary endpoint. Across both trials, BRUKINSA achieved an ORR, which is the sum of complete responses and partial responses of 84 percent.

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In the multicenter Phase 2 trial of zanubrutinib in patients with relapsed or refractory (R/R) MCL BGB-3111-206, the ORR was 84% (95% CI: 74%, 91%), including 59% complete response (FDG-PET scan required) and 24% partial response. 

In this study, the median duration of response (DOR) was 19.5 months (95%CI: 16.6, NE) and median follow-up time on study was 18.4 months. In the global Phase 1/2 trial BGB-3111-AU-003, the ORR was 84% (95% CI: 67%, 95%), including 22% complete response (FDG-PET scan not required) and 62% partial response. 

In this study, the median DOR was 18.5 months1 (95% CI:12.6, NE) and median follow-up time on study was 18.8 months.

The most common adverse reactions (> 10%) with BRUKINSA were decreased neutrophil count, decreased platelet count, upper respiratory tract infection, decreased white blood cell count, decreased hemoglobin, rash, bruising, diarrhea, cough, musculoskeletal pain, pneumonia, urinary tract infection, blood in the urine (hematuria), fatigue, constipation, and hemorrhage. 

The most frequent serious adverse reactions were pneumonia (11%) and hemorrhage (5%).

The recommended dose of BRUKINSA is 320 mg, taken orally 160 mg twice daily or 320 mg once daily with or without food. The dose may be adjusted for adverse reactions and reduced for patients with severe hepatic impairment and certain drug interactions.

New Drug Applications (NDAs) in China for relapsed refractory (R/R) MCL and R/R chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma have been accepted by the China National Medical Products Administration and granted priority review and are pending approval.

BeiGene is committed to ensuring that people have access to the medicine and the support needed to have the best possible outcomes and experiences. Coinciding with today’s approval, BeiGene is launching myBeiGene™ in the United States to support patients, caregivers, and healthcare providers with access to BRUKINSA.

Cancer news published by Precision Vaccinations