April 14, 2024

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Canada approved Brukinsa® (Zanubrutinib) for the treatment of  Fahrenheit’s macroglobulinemia

Canada approved Brukinsa® (Zanubrutinib) for the treatment of  Fahrenheit’s macroglobulinemia


Canada approved Brukinsa® (Zanubrutinib) for the treatment of  Fahrenheit’s macroglobulinemia.   

Approved based on the results of the ASPEN Phase 3 clinical trial of Brukinsa® (Zanubrutinib) vs. Ibrutinib.


Canada approved Brukinsa® (Zanubrutinib) for Fahrenheit's macroglobulinemia



Marks Brukinsa® (Zanubrutinib)for the treatment of Fahrenheit’s macroglobulinemia and BeiGene’s first listing in Canada was approved.


On March 2, 2021, BeiGene (Nasdaq: BGNE; Hong Kong Stock Exchange: 06160) is a biotechnology company in the commercial stage, focusing on the development and commercialization of innovative drugs on a global scale.

The company announced today that the Canadian Drug Administration has approved a new drug application for the treatment of Wahrenheit Macroglobulinemia (WM) patients with Brukinsa® (Zanubrutinib).


Mr. Josh Neiman, Chief Commercial Officer of BeiGene North America and Europe, said: “Brukinsa® (Zanubrutinib) is a highly selective BTK inhibitor designed to bring deep and lasting relief to patients with hematological malignancies, and at the same time Reduce the frequency of certain side effects.


We look forward to this approval to bring Brukinsa® (Zanubrutinib), a potentially best-in-class BTK inhibitor, to WM patients in Canada.

We will continue to work hard to ensure the accessibility of Brukinsa® (Zanubrutinib) in Canada and provide this innovative drug to patients in more markets around the world. “


Christine Chen, MD, associate professor at the University of Toronto and clinical researcher at Princess Margaret Cancer Center, said: “WM is a rare but very serious disease.

Although BTK inhibitors have improved the overall treatment of WM, not all patients can This is alleviated, and intolerance caused by side effects is still a problem, especially for elderly patients.

The clinical trial results of ASPEN prove that Brukinsa® (Zanubrutinib) is expected to bring clinical benefits and safety to WM patients. Advantages have brought new hope to this patient group.”


Mr. Paul Kitchen, Chairman of the Wahrenheit Macroglobulinemia Foundation (WMFC) of Canada, commented: “WMFC is excited about the approval by the Canadian Drug Administration as a therapy for WM. It will further bring a variety of high-quality treatment options to the Canadian WM patient population. Just like the results of the ASPEN clinical trial, Brukinsa® (Zanubrutinib)is expected to improve the treatment effect for Canadian patients.”


In September 2020, the Canadian Drug Administration included the new drug marketing application of Brukinsa® (Zanubrutinib)for the treatment of WM patients into the priority review.

This approval is based on the effective results of the ASPEN clinical trial.

The ASPEN clinical trial is a randomized, open, multi-center phase 3 clinical trial (NCT03053440) to evaluate the use of Brukinsa® (Zanubrutinib) versus ibrutinib for the treatment of relapsed/refractory patients carrying MYD88 gene mutations (MYD88MUT) ( R/R) or naive (TN) WM patients.


In this trial, Brukinsa® (Zanubrutinib) produced a higher rate of very good partial remission (VGPR) in patients compared with ibrutinib and was more advantageous in terms of safety, although the results of this clinical study were not The primary endpoint can be reached, that is, a statistically significant superiority in the deep remission rate (VGPR or better) [i].


After the independent review committee (IRC) updated the remission standard assessment according to the 6th International Waldenstrom’s Macroglobulinemia Symposium (IWWM), the complete remission (CR) + VGPR of Brukinsa® (Zanubrutinib) in the overall intention-to-treat (ITT) population The combined rate was 28.4% (95% CI: 20, 38), and ibrutinib was 19.2% (95% CI: 12, 28) [i].


In the ASPEN clinical trial of 101 WM patients who were randomized to receive Brukinsa® (Zanubrutinib) treatment, 4% of the patients discontinued treatment due to adverse events, including cardiac enlargement, neutropenia, plasma cell myeloma and dura mater Bleeding.

14% of patients reduced the dose due to adverse events, the most common of which were neutropenia (3.0%) and diarrhea (2.0%) [i].


The overall safety data of Brukinsa® (Zanubrutinib) comes from 779 patients with B-cell malignant tumors who have been treated by Brukinsa® (Zanubrutinib) in multiple clinical trials.

The most common adverse reactions (≥10%) are neutropenia, Thrombocytopenia, upper respiratory tract infection, anemia, skin rash, musculoskeletal pain, diarrhea, cough, contusion, pneumonia (group term), urinary tract infection, bleeding (group term), and hematuria. The most common serious adverse reactions (≥2%) were pneumonia (10.0%) and bleeding (2.1%) [i].


The recommended total daily dose of Brukinsa® (Zanubrutinib) is 320mg. Brukinsa® (Zanubrutinib) is expected to be launched in Canada in the next few weeks.




About Fahrenheit Macroglobulinemia

Waldenstrom’s macroglobulinemia (WM) is a rare indolent B-cell lymphoma that occurs in less than 2% of patients with non-Hodgkin’s lymphoma (NHL).

The disease usually occurs in older patients and is mainly found in the bone marrow, but it may also involve the lymph nodes and spleen [ii].

In Canada and the United States, the incidence of WM is approximately five cases per million people per year [iii].


About ASPEN clinical trials

This randomized, open, multi-center ASPEN Phase 3 clinical trial (clinicaltrials.gov registration number: NCT03053440) was used to evaluate the treatment of Relapsed/Refractory (R/R) and initial treatment ( TN) Patients with Waldenstrom’s macroglobulinemia (WM).

The main purpose of the trial is to evaluate the complete remission (CR) or very good partial remission (VGPR) to confirm the superiority of Brukinsa® (Zanubrutinib)compared with Ibrutinib.

The secondary endpoints of the trial include the primary remission rate, duration of remission, progression-free survival, and safety (determined by the incidence, time, and severity of adverse events during treatment).

The trial’s pre-determined analysis patient population includes all patients (n=201) and R/R patients (n=164). The exploratory end point of the trial included a quality of life measurement.


The trial included two cohorts, one was a random cohort (cohort 1), which enrolled 201 patients with MYD88 gene mutations, and the other was a non-random cohort (cohort 2), which enrolled 28 patients with MYD88 wild genotype (MYD88WT). ) All patients were treated with Zebutinib. Such patients have poor efficacy after receiving ibrutinib in historical studies.


Random cohort 1 enrolled 102 patients in the Zebutinib trial arm, of which 83 were relapsed or refractory (R/R) patients and 19 were naive (TN) patients; in Ibrutinib 99 patients were enrolled in the test arm, of which 81 were R/R patients and 18 were TN patients.

Patients enrolled in the trial arm of Zebutinib received a dose of 160 mg twice a day (BID) of Zebutinib; patients enrolled in the trial arm of Ibrutinib received a dose of 420 per time Milligrams, once a day (QD) Ibrutinib treatment.


The results of cohort 2 were previously announced at the 24th European Hematology Association (EHA) annual meeting, which showed an overall response rate (ORR) of 80.8%, a major response rate (MRR; including partial response or better) rate It was 53.8%, and the VGPR rate was 23.1%.



About Brukinsa® (Zanubrutinib)

Brukinsa® (Zanubrutinib) is a small molecule inhibitor of Bruton’s tyrosine kinase (BTK) independently developed by BeiGene scientists. It is currently undergoing a wide range of key clinical trials worldwide. Monotherapy and combination therapy with other therapies treat a variety of B-cell malignancies.


Brukinsa® (Zanubrutinib) has been approved in the following indications and regions:

  • In November 2019, Brukinsa® (Zanubrutinib)was approved in the United States for the treatment of mantle cell lymphoma (MCL) patients who have received at least one therapy in the past*
  • In June 2020, Brukinsa® (Zanubrutinib) was approved in China for the treatment of adult mantle cell lymphoma (MCL) patients who have received at least one treatment in the past**
  • In June 2020, Brukinsa® (Zanubrutinib) was approved in China for the treatment of adult chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) patients who have received at least one treatment in the past
  • In February 2021, Brukinsa® (Zanubrutinib) was approved in the United Arab Emirates for the treatment of patients with relapsed or refractory MCL
  • In March 2021, Brukinsa® (Zanubrutinib) was approved in Canada for the treatment of adult patients with Waldenstrom’s macroglobulinemia (WM)
  • In Canada, an application for marketing authorization for Brukinsa® (Zanubrutinib) as a treatment plan for MCL patients who have received at least one therapy in the past has been accepted and is under review. In addition, another 20 related listing applications of Brukinsa® (Zanubrutinib) have been submitted in 40 countries and regions, including the United States, China and the European Union.







Canada approved Brukinsa® (Zanubrutinib) for the treatment of  Fahrenheit’s macroglobulinemia

(source:internet, reference only)

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