{"id":760714,"date":"2023-05-30T07:03:54","date_gmt":"2023-05-30T11:03:54","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/brukinsa-approved-in-canada-for-the-treatment-of-chronic-lymphocytic-leukemia\/"},"modified":"2023-05-30T07:03:54","modified_gmt":"2023-05-30T11:03:54","slug":"brukinsa-approved-in-canada-for-the-treatment-of-chronic-lymphocytic-leukemia","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/brukinsa-approved-in-canada-for-the-treatment-of-chronic-lymphocytic-leukemia\/","title":{"rendered":"BRUKINSA\u00ae Approved in Canada for the Treatment of Chronic Lymphocytic Leukemia"},"content":{"rendered":"

<\/p>\n

BRUKINSA\u00ae<\/sup> Approved in Canada for the Treatment of Chronic Lymphocytic Leukemia<\/b><\/p>\n

BeiGene\u2019s BTKi is approved in more than 65 markets globally<\/i><\/p>\n

BASEL, Switzerland & BEIJING & CAMBRIDGE, Mass.–(BUSINESS WIRE<\/a>)–
\nBeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, announced today that BRUKINSA (zanubrutinib), a Bruton’s tyrosine kinase inhibitor (BTKi),has been approved by Health Canada for the treatment of adult patients with chronic lymphocytic leukemia (CLL).<\/p>\n

\n\u201cBRUKINSA now has four approved indications in Canada, demonstrating our commitment to bring this innovative BTKi treatment option to more patients across the world,\u201d said Mehrdad Mobasher, M.D., M.P.H., Chief Medical Officer, Hematology at BeiGene. \u201cOur bold development program for BRUKINSA in CLL provided evidence for superior efficacy in the first-line and relapsed\/refractory treatment settings, positioning BRUKINSA to become the BTKi of choice.\u201d<\/p>\n

\nTypically diagnosed among individuals in their early 70s, CLL is a slow-growing, incurable blood cancer and is the most common leukemia in adults.1<\/sup><\/p>\n

\n\u201cBecause CLL is a chronic disease with many patients often living with multiple health conditions, access to effective treatment options with safe and favorable tolerability profiles is critical,\u201d says Dr. Christine Chen, MMEd, MD, FRCPC, Clinician Investigator, Princess Margaret Cancer Centre. \u201cThat is why the approval of zanubrutinib is seen as a clinical home run – not only did it demonstrate a significant clinical benefit in the first line CLL setting but it delivered superior efficacy versus ibrutinib in patients with relapsed or refractory disease and did so with less toxicity. And because most CLL patients are ultimately treated on and off for years, zanubrutinib may represent a safer and more effective option for patients with CLL.\u201d<\/p>\n

\nThe Health Canada approval of BRUKINSA for CLL is based on positive efficacy results and a favorable safety profile from two global Phase 3, randomized, open-label, multicenter clinical trials: SEQUOIA (NCT03336333), comparing zanubrutinib against bendamustine plus rituximab (BR) in patients with previously untreated CLL, and ALPINE (NCT03734016), comparing zanubrutinib against ibrutinib in patients with relapsed or refractory (R\/R) CLL.2<\/sup><\/p>\n

\nConsidered the largest head-to-head study of BTK inhibitors in R\/R CLL, the final ALPINE trial data were presented in a late-breaking session at the 64th American Society of Hematology Annual Meeting in December 2022 and simultaneously reported in The<\/i>New England Journal of Medicine<\/i>.3,4 <\/sup>SEQUOIA trial results were published in The Lancet Oncology<\/i> in August 2022.5<\/sup><\/p>\n

\n\u201cCLL Canada applauds continued innovation when it comes to addressing the needs of Canadians who live with CLL. The approval of zanubrutinib represents a significant advance for patients who can benefit from an additional treatment option,\u201d says Raymond Vles, Board Chair, CLL Canada. \u201cMore importantly, becoming informed and connecting with the CLL patient community will enable people with CLL to discuss with their doctor the treatment and dosing options that will work best for them and their lifestyle.\u201d<\/p>\n

About CLL2
\n
<\/sup><\/b>CLL is a type of blood cancer. Over 2,200 people in Canada are diagnosed with CLL each year. CLL is more common in men and occurs mainly in people over 60, with the average age of diagnosis in the early 70s.<\/p>\n

About BRUKINSA (zanubrutinib)
\n
<\/b>BRUKINSA is a small-molecule inhibitor of Bruton\u2019s tyrosine kinase discovered by BeiGene scientists that is currently being evaluated globally in a broad clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies. BRUKINSA was specifically designed to deliver targeted and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared to other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease-relevant tissues.<\/p>\n

\nBRUKINSA is supported by a broad clinical program which includes more than 4,900 subjects in 35 trials across 29 markets. To date, BRUKINSA is approved in more than 65 markets around the world, including the United States, China, the European Union, Great Britain, Canada, Australia, South Korea, and Switzerland.<\/p>\n

About BeiGene
\n
<\/b>BeiGene is a global biotechnology company that is discovering and developing innovative oncology treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 9,400 colleagues spans five continents, with administrative offices in Basel; Beijing; and Cambridge, U.S. To learn more about BeiGene, please visit www.beigene.com<\/a> and follow us on Twitter at @BeiGeneGlobal.<\/p>\n

Forward-Looking Statements
\n
<\/b>This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding the potential for BRUKINSA to provide clinical benefit to patients with CLL and to become the BTKi of choice; the potential for BRUKINSA to be a safer and more effective treatment option for patients; the future development, regulatory filing and approval, commercialization, and market access of BRUKINSA; and BeiGene\u2019s plans, commitments, aspirations, and goals under the heading \u201cAbout BeiGene.\u201d Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeiGene’s ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing, and progress of clinical trials and marketing approval; BeiGene’s ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeiGene’s ability to obtain and maintain protection of intellectual property for its medicines and technology; BeiGene’s reliance on third parties to conduct drug development, manufacturing, and other services; BeiGene\u2019s limited experience in obtaining regulatory approvals and commercializing pharmaceutical products and its ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates and achieve and maintain profitability; and the impact of the COVID-19 pandemic on BeiGene\u2019s clinical development, regulatory, commercial, manufacturing, and other operations, as well as those risks more fully discussed in the section entitled \u201cRisk Factors\u201d in BeiGene\u2019s most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeiGene’s subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeiGene undertakes no duty to update such information unless required by law.<\/p>\n

IMPORTANT U.S. SAFETY INFORMATION
\n
<\/span><\/span><\/b>Warnings and Precautions<\/span><\/b><\/p>\n

Hemorrhage<\/b><\/p>\n

\nFatal and serious hemorrhage has occurred in patients with hematological malignancies treated with BRUKINSA monotherapy. Grade 3 or higher hemorrhage, including intracranial and gastrointestinal hemorrhage, hematuria and hemothorax have been reported in 3.6% of patients treated with BRUKINSA monotherapy in clinical trials, with fatalities occurring in 0.3% of patients. Bleeding of any grade, excluding purpura and petechiae, occurred in 30% of patients.<\/p>\n

\nBleeding has occurred in patients with and without concomitant antiplatelet or anticoagulation therapy. Coadministration of BRUKINSA with antiplatelet or anticoagulant medications may further increase the risk of hemorrhage.<\/p>\n

\nMonitor for signs and symptoms of bleeding. Discontinue BRUKINSA if intracranial hemorrhage of any grade occurs. Consider the benefit-risk of withholding BRUKINSA for 3-7 days pre- and post-surgery depending upon the type of surgery and the risk of bleeding.<\/p>\n

Infections<\/b><\/p>\n

\nFatal and serious infections (including bacterial, viral, or fungal infections) and opportunistic infections have occurred in patients with hematological malignancies treated with BRUKINSA monotherapy. Grade 3 or higher infections occurred in 24% of patients, most commonly pneumonia (11%), with fatal infections occurring in 2.9% of patients. Infections due to hepatitis B virus (HBV) reactivation have occurred.<\/p>\n

\nConsider prophylaxis for herpes simplex virus, pneumocystis jiroveci pneumonia, and other infections according to standard of care in patients who are at increased risk for infections. Monitor and evaluate patients for fever or other signs and symptoms of infection and treat appropriately.<\/p>\n

Cytopenias<\/b><\/p>\n

\nGrade 3 or 4 cytopenias, including neutropenia (22%), thrombocytopenia (8%) and anemia (7%) based on laboratory measurements, developed in patients treated with BRUKINSA monotherapy. <\/i>Grade 4 neutropenia occurred in 11% of patients, and Grade 4 thrombocytopenia occurred in 2.8% of patients.<\/p>\n

\nMonitor complete blood counts regularly during treatment and interrupt treatment, reduce the dose, or discontinue treatment as warranted. Treat using growth factor or transfusions, as needed.<\/p>\n

Second Primary Malignancies<\/b><\/p>\n

\nSecond primary malignancies, including non-skin carcinoma, have occurred in 13% of patients treated with BRUKINSA monotherapy. The most frequent second primary malignancy was non-melanoma skin cancer reported in 7% of patients. Other second primary malignancies included malignant solid tumors (5%), melanoma (1.2%), and hematologic malignancies (0.5%). Advise patients to use sun protection and monitor patients for the development of second primary malignancies.<\/p>\n

Cardiac Arrhythmias<\/b><\/p>\n

\nSerious cardiac arrhythmias have occurred in patients treated with BRUKINSA. Atrial fibrillation and atrial flutter were reported in 3.7% of 1550 patients treated with BRUKINSA monotherapy, including Grade 3 or higher cases in 1.7% of patients. Patients with cardiac risk factors, hypertension and acute infections may be at increased risk. Grade 3 or higher ventricular arrhythmias were reported in 0.2% of patients.<\/p>\n

\nMonitor for signs and symptoms for cardiac arrhythmias (e.g. palpitations, dizziness, syncope, dyspnea, chest discomfort), manage appropriately, and consider the risks and benefits of continued BRUKINSA treatment.<\/p>\n

Embryo-Fetal Toxicity<\/b><\/p>\n

\nBased on findings in animals, BRUKINSA can cause fetal harm when administered to a pregnant woman. Administration of zanubrutinib to pregnant rats during the period of organogenesis caused embryo-fetal toxicity, including malformations at exposures that were 5 times higher than those reported in patients at the recommended dose of 160 mg twice daily. Advise women to avoid becoming pregnant while taking BRUKINSA and for 1 week after the last dose. Advise men to avoid fathering a child during treatment and for 1 week after the last dose. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus.<\/p>\n

Adverse Reactions<\/span><\/b><\/p>\n

\nThe most common adverse reactions (\u226530%), including laboratory abnormalities, included decreased neutrophil count (42%), upper respiratory tract infection (39%), decreased platelet count (34%), hemorrhage (30%), and musculoskeletal pain (30%).<\/p>\n

Drug Interactions<\/span><\/b><\/p>\n

CYP3A Inhibitors:<\/b> When BRUKINSA is co-administered with a strong CYP3A inhibitor, reduce BRUKINSA dose to 80 mg once daily. For coadministration with a moderate CYP3A inhibitor, reduce BRUKINSA dose to 80 mg twice daily.<\/p>\n

CYP3A Inducers:<\/b> Avoid coadministration with strong or moderate CYP3A inducers. Dose adjustment may be recommended with moderate CYP3A inducers.<\/p>\n

Specific Populations<\/span><\/b><\/p>\n

Lactation: <\/b>Advise not to breastfeed.<\/p>\n

Hepatic Impairment: <\/b>The recommended dose of BRUKINSA for patients with severe hepatic impairment is 80 mg orally twice daily.<\/p>\n

U.S. INDICATIONS<\/span><\/b><\/p>\n

\nBRUKINSA is indicated for the treatment of adult patients with:<\/p>\n