{"id":57426,"date":"2023-05-17T13:03:32","date_gmt":"2023-05-17T11:03:32","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/the-max-foundation-beigene-and-the-beigene-foundation-announce-collaboration-to-advance-health-equity-by-providing-access-to-brukinsa-for-the-treatment-of-chronic-lymphocytic-leukemia-in-low\/"},"modified":"2023-05-17T13:03:32","modified_gmt":"2023-05-17T11:03:32","slug":"the-max-foundation-beigene-and-the-beigene-foundation-announce-collaboration-to-advance-health-equity-by-providing-access-to-brukinsa-for-the-treatment-of-chronic-lymphocytic-leukemia-in-low","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/the-max-foundation-beigene-and-the-beigene-foundation-announce-collaboration-to-advance-health-equity-by-providing-access-to-brukinsa-for-the-treatment-of-chronic-lymphocytic-leukemia-in-low\/","title":{"rendered":"The Max Foundation, BeiGene, and the BeiGene Foundation Announce Collaboration to Advance Health Equity by Providing Access to BRUKINSA\u00ae for the Treatment of Chronic Lymphocytic Leukemia in Low- and Middle-Income Countries"},"content":{"rendered":"
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SEATTLE & BASEL, Switzerland & BEIJING & CAMBRIDGE, Mass.–(BUSINESS WIRE)–$BGNE<\/a> #BTKi<\/a>–The Max Foundation (Max), a global nonprofit organization dedicated to accelerating health equity by delivering medication, technology, and supportive services to patients worldwide, BeiGene, a global biotechnology company, and the BeiGene Foundation, a nonprofit charitable foundation, today announced a collaboration to provide access to BRUKINSA (zanubrutinib) for the treatment of adult patients with chronic lymphocytic leukemia (CLL) in 29 low- and middle-income countries over the next three years. This collaboration advances each organization\u2019s focus on patient access by combining Max\u2019s expertise and infrastructure with a donated product from BeiGene, and a grant from the BeiGene Foundation.<\/p>\n

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\n\u201cWe are thrilled to partner with BeiGene to help people living with CLL in low- and middle-income countries have access to BRUKINSA,\u201d said Pat Garcia-Gonzalez, CEO of Max. \u201cThis collaboration marks the first time patients with CLL will have access to treatment through Max. We commend BeiGene for joining our Humanitarian Partnership for Access to Cancer Treatments (Humanitarian PACT) the same year BRUKINSA received its U.S. approval in CLL, demonstrating a powerful commitment to health equity for patients regardless of where they live.\u201d<\/p>\n

\nThe Humanitarian PACT is a collaboration among professional, nonprofit, and commercial organizations that share the commitment of Max to increase global access to treatment, care, and support for people living with cancer. Members of the Humanitarian PACT agree to invest resources and\/or their unique organizational knowledge and capabilities to support the expansion of Max\u2019s proven treatment access model.<\/p>\n

\n\u201cWhen I started BeiGene, my goal was to ensure more patients have access to critical medicines regardless of geography or socioeconomic status,\u201d said John V. Oyler, Co-Founder, Chairman and CEO of BeiGene. \u201cThis collaboration with Max is a critical step in achieving this objective and emphasizes the necessity of high-impact partnerships to remove some of the obstacles that prevent patients\u2019 access to treatment.\u201d<\/p>\n

\nDuring the second half of 2023, Max will partner with leading physicians in target low- and middle-income countries to set up a robust access pathway for patients for whom they prescribe BRUKINSA. CLL is the most common leukemia in adults, accounting for about one third of new cases of leukemia worldwide1<\/sup>. Globally, there are around 40,000 deaths due to CLL per year2<\/sup>.<\/p>\n

\nAbout The Max Foundation<\/b><\/p>\n

\nThe Max Foundation is a global health nonprofit organization dedicated to accelerating health equity. For 26 years, Max has pioneered practical, scalable, high-quality solutions to bring lifesaving treatments and patient-centered health care to more than 100,000 people living with cancer and critical illness in low- and middle-income countries. Max believes in a world where all people can access high-impact medicines, where geography is not destiny, and where everyone can strive for health with dignity and with hope. Learn more at www.themaxfoundation.org<\/a>.<\/p>\n

\nAbout BeiGene<\/b><\/p>\n

\nBeiGene 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<\/a>.<\/p>\n

\nAbout the BeiGene Foundation<\/b><\/p>\n

\nThe BeiGene Foundation is a charitable organization established by BeiGene, Ltd. It is a separate legal entity from BeiGene, Ltd. with distinct legal restrictions. The foundation\u2019s mission is to deliver health equity, access to quality healthcare, disaster relief, and community engagement.<\/p>\n

\nBRUKINSA\u00ae<\/sup> (zanubrutinib) U.S. IMPORTANT SAFETY INFORMATION<\/b><\/p>\n

\nWarnings and Precautions<\/b><\/p>\n

\nHemorrhage<\/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

\nInfections<\/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 jirovecii 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

\nCytopenias<\/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

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

\nSecond primary malignancies, including non-skin carcinoma, have occurred in 13% of patients treated with BRUKINSA monotherapy. <\/i>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

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

\nEmbryo-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

\nAdverse Reactions<\/b><\/p>\n

\nIn this pooled safety population, the most common adverse reactions, including laboratory abnormalities, in \u226530% of patients who received BRUKINSA (N=1550) included decreased neutrophil count (42%), upper respiratory tract infection (39%), decreased platelet count (34%), hemorrhage (30%), and musculoskeletal pain (30%).<\/p>\n

\nDrug Interactions<\/b><\/p>\n

\nCYP3A 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

\nCYP3A Inducers:<\/b> Avoid coadministration with strong or moderate CYP3A inducers. Dose adjustment may be recommended with moderate CYP3A inducers.<\/p>\n

\nSpecific Populations<\/b><\/p>\n

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

\nINDICATIONS<\/b><\/p>\n

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