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CAMBRIDGE, Mass. and BEIJING, China, Nov. 14, 2019 (GLOBE NEWSWIRE) — BeiGene Co.,Ltd (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical aggregation focused on developing and commercializing avant-garde molecularly-targeted and immuno-oncology drugs for the analysis of cancer, today appear that BRUKINSA™ (zanubrutinib) has accustomed accelerated approval from the United States Aliment and Biologic Administration (FDA) as a analysis for crimson corpuscle lymphoma (MCL) in developed patients who accept accustomed at atomic one above-mentioned therapy.1 BRUKINSA is the aboriginal BeiGene-discovered artefact to be approved, an important anniversary against the company’s ambition of transforming analysis for blight patients about the world.
This accelerated approval is based on all-embracing acknowledgment amount (ORR). Continued approval for this adumbration may be accidental aloft analysis and description of analytic account in a acknowledging trial.
“We are alive to advance outcomes for bodies with blight accustomed and this approval brings us afterpiece to acumen our mission of bringing the accomplished affection therapies to patients globally,” said John V. Oyler, Chairman, Co-Founder, and CEO of BeiGene. “Today’s FDA approval of BRUKINSA, afterward the ahead accustomed Breakthrough Analysis appellation in this indication, validates it as an important analysis advantage for bodies with relapsed or adverse MCL. We achievement this is the aboriginal of abounding approvals for BRUKINSA as we abide to appraise its abeyant in added hematologic cancers.”
“BRUKINSA is a BTK inhibitor that was advised to aerate ambition control and abbreviate astray binding. It entered the dispensary in 2014 and back that time our ample development affairs has enrolled added than 1,600 patients globally,” said Jane Huang, M.D., Chief Medical Officer, Hematology at BeiGene. “Today’s accelerated approval is the acme of abounding years of accomplishment by the BeiGene team, the committed board complex in these trials and, best importantly, the patients who alternate by enrolling in the analytic trials. We are ashamed by the befalling to advance this analysis and barrage it as our aboriginal internally apparent and accustomed blight treatment.”
“BTK inhibition is an accustomed approach of analysis for patients with MCL, but abounding patients advised with ahead accustomed BTK inhibitors do not absolutely acknowledge to BTK analysis or are affected to abandon analysis aboriginal due to ancillary effects. Today we accept a new advantage for our developed patients who accept accustomed one above-mentioned systemic or targeted analysis and are active with MCL, an advancing claret blight that’s generally diagnosed at a added avant-garde stage,” said Luhua (Michael) Wang, M.D., Professor, Department of Lymphoma and Myeloma, Division of Blight Anesthetic at The University of Texas MD Anderson Blight Center, and analytic balloon investigator.
“The approval of BRUKINSA as a added band analysis represents an important advance for the analysis of crimson corpuscle lymphoma,” said Meghan Gutierrez, Chief Executive Officer for the Lymphoma Research Foundation. “Expanded analysis options can transform the accommodating acquaintance and accommodate achievement to bodies active with a crimson corpuscle diagnosis.”
The FDA’s approval of BRUKINSA is based on adeptness after-effects from two single-arm analytic trials, with absolute analysis board (IRC)-assessed ORR per 2014 Lugano Classification as the primary endpoint. Across both trials, BRUKINSA accomplished an ORR, which is the sum of complete responses and fractional responses, of 84%.
In the multicenter Phase 2 balloon of zanubrutinib in patients with relapsed or adverse (R/R) MCL BGB-3111-206 (NCT03206970), the ORR was 84% (95% CI: 74%, 91%), including 59% complete acknowledgment (FDG-PET browse required) and 24% fractional response. In this study, the average continuance of acknowledgment (DOR) was 19.5 months (95%CI: 16.6, NE) and average aftereffect time on abstraction was 18.4 months. In the all-around Phase 1/2 balloon BGB-3111-AU-003 (NCT02343120), the ORR was 84% (95% CI: 67%, 95%), including 22% complete acknowledgment (FDG-PET browse not required) and 62% fractional response. In this study, the average DOR was 18.5 months1 (95% CI:12.6, NE) and average aftereffect time on abstraction was 18.8 months.
The best accustomed adverse reactions (> 10%) with BRUKINSA were decreased neutrophil count, decreased platelet count, high respiratory amplitude infection, decreased white claret corpuscle count, decreased hemoglobin, rash, bruising, diarrhea, cough, musculoskeletal pain, pneumonia, urinary amplitude infection, claret in the urine (hematuria), fatigue, constipation, and hemorrhage. The best accepted austere adverse reactions were pneumonia (11%) and drain (5%).
Of the 118 patients with MCL advised with BRUKINSA, eight (7%) patients discontinued analysis due to adverse reactions in the trials. The best accepted adverse acknowledgment arch to analysis cessation was pneumonia (3.4%). One (0.8%) accommodating accomplished an adverse acknowledgment arch to dosage abridgement (hepatitis B).
The recommended dosage of BRUKINSA is 320 mg, taken orally 160 mg alert circadian or 320 mg already circadian with or afterwards food. The dosage may be adapted for adverse reactions, and bargain for patients with astringent hepatic crime and assertive biologic interactions.1
BRUKINSA is accustomed to be accessible to bodies in the United States in the advancing weeks.
myBeiGene™ Accommodating Abutment Affairs
BeiGene is committed to ensuring that bodies accept admission to the anesthetic and the abutment bare to accept the best accessible outcomes and experiences. Coinciding with today’s approval, BeiGene is ablution myBeiGene™ in the United States to abutment patients, caregivers, and healthcare providers with admission to BRUKINSA. The myBeiGene affairs goes above banking abetment abutment to accommodate patients and caregivers with apprenticeship about their ache and analysis with BRUKINSA, as able-bodied accommodate applied and affecting abutment by abutting them to third-party assets that can abode their abandoned different needs. For added advice on myBeiGene, amuse alarm 1-833-234-4363 or appointment Media Crimson Corpuscle Lymphoma (MCL)
Lymphoma is a assorted accumulation of cancers that arise from B-, T- or NK- cells. MCL is about an advancing anatomy of non-Hodgkin’s lymphoma (NHL) that arises from B-cells basic in the “mantle zone.”2 In the United States, about 74,200 bodies will be diagnosed with NHL in 2019,3 with MCL apery about six percent (about 4,452 cases) of all new cases of NHL.2 MCL usually has a poor prognosis, with a average adaptation of three to four years,4 and it generally diagnosed at a afterwards date of disease.
About BRUKINSA (zanubrutinib)
BRUKINSA is a baby atom inhibitor of Bruton’s tyrosine kinase (BTK), apparent by BeiGene scientists, that is currently actuality evaluated globally in a ample cardinal analytic affairs as a monotherapy and in aggregate with added therapies to amusement assorted B-cell malignancies. BRUKINSA was accustomed by the U.S. FDA to amusement developed patients with MCL who accept accustomed at atomic one above-mentioned analysis on November 14, 2019.
New Biologic Applications (NDAs) in China for relapsed adverse (R/R) MCL and R/R abiding lymphocytic leukemia (CLL) or baby lymphocytic lymphoma (SLL) accept been accustomed by the China National Medical Articles Administration (NMPA) and accustomed antecedence analysis and are awaiting approval.
BRUKINSA is not accustomed for use alfresco the United States.
IMPORTANT SAFETY INFORMATION FOR BRUKINSA (ZANUBRUTINIB)
Warnings and Precautions
Fatal and austere hemorrhagic contest accept occurred in patients with hematological malignancies advised with BRUKINSA monotherapy. Brand 3 or college bleeding contest including intracranial and gastrointestinal hemorrhage, hematuria and hemothorax accept been appear in 2% of patients advised with BRUKINSA monotherapy. Bleeding contest of any grade, including purpura and petechiae, occurred in 50% of patients advised with BRUKINSA monotherapy.
Bleeding contest accept occurred in patients with and afterwards accessory antiplatelet or anticoagulation therapy. Co-administration of BRUKINSA with antiplatelet or anticoagulant medications may added access the accident of hemorrhage.
Monitor for signs and affection of bleeding. Abandon BRUKINSA if intracranial drain of any brand occurs. Consider the benefit-risk of denial BRUKINSA for 3-7 canicule pre- and post-surgery depending aloft the blazon of anaplasty and the accident of bleeding.
Fatal and austere infections (including bacterial, viral, or fungal) and adept infections accept occurred in patients with hematological malignancies advised with BRUKINSA monotherapy. Brand 3 or college infections occurred in 23% of patients advised with BRUKINSA monotherapy. The best accustomed Brand 3 or college infection was pneumonia. Infections due to hepatitis B virus (HBV) reactivation accept occurred.
Consider prophylaxis for canker canker virus, pneumocystis jiroveci pneumonia and added infections according to accepted of affliction in patients who are at added accident for infections. Monitor and appraise patients for agitation or added signs and affection of infection and amusement appropriately.
Grade 3 or 4 cytopenias, including neutropenia (27%), thrombocytopenia (10%) and anemia (8%) based on class measurements, were appear in patients advised with BRUKINSA monotherapy.
Monitor complete claret counts during analysis and amusement application advance agency or transfusions, as needed.
Second Primary Malignancies
Second primary malignancies, including non-skin carcinoma, accept occurred in 9% of patients advised with BRUKINSA monotherapy. The best accepted added primary blight was bark blight (basal corpuscle blight and squamous corpuscle blight of skin), appear in 6% of patients. Advise patients to use sun protection.
Atrial fibrillation and atrial agitate accept occurred in 2% of patients advised with BRUKINSA monotherapy. Patients with cardiac accident factors, hypertension, and astute infections may be at added risk. Brand 3 or college contest were appear in 0.6% of patients advised with BRUKINSA monotherapy. Monitor signs and affection for atrial fibrillation and atrial agitate and administer as appropriate.
Based on allegation in animals, BRUKINSA can account fetal abuse back administered to a abundant woman. Administration of zanubrutinib to abundant rats during the aeon of organogenesis acquired embryo-fetal toxicity, including malformations at exposures that were 5 times college than those appear in patients at the recommended dosage of 160 mg alert daily. Advise women to abstain acceptable abundant while demography BRUKINSA and for at atomic 1 anniversary afterwards the aftermost dose. Advise men to abstain fathering a adolescent during analysis and for at atomic 1 anniversary afterwards the aftermost dose. If this biologic is acclimated during pregnancy, or if the accommodating becomes abundant while demography this drug, the accommodating should be acquainted of the abeyant hazard to a fetus.
The best accustomed adverse reactions in > 10% of patients who accustomed BRUKINSA were neutrophil calculation decreased (53%), platelet calculation decreased (39%), high respiratory amplitude infection (38%), white claret corpuscle calculation decreased (30%), claret decreased (29%), adventurous (25%), able-bodied (23%), diarrhea (20%), ahem (20%), musculoskeletal affliction (19%), pneumonia (18%), urinary amplitude infection (13%), hematuria (12%), fatigue (11%), ache (11%), and drain (10%). The best accepted austere adverse reactions were pneumonia (11%) and drain (5%).
CYP3A Inhibitors: When BRUKINSA is co-administered with a able CYP3A inhibitor, abate BRUKINSA dosage to 80 mg already daily. For coadministration with a abstinent CYP3A inhibitor, abate BRUKINSA dosage to 80 mg alert daily.
CYP3A Inducers: Avoid coadministration with abstinent or able CYP3A inducers.
Hepatic Impairment: The recommended dosage of BRUKINSA for patients with astringent hepatic crime is 80 mg orally alert daily.
BRUKINSA is a kinase inhibitor adumbrated for the analysis of developed patients with crimson corpuscle lymphoma (MCL) who accept accustomed at atomic one above-mentioned therapy.
This adumbration is accustomed beneath accelerated approval based on all-embracing acknowledgment rate. Continued approval for this adumbration may be accidental aloft analysis and description of analytic account in a acknowledging trial.
Please see full Prescribing Advice at Media and Accommodating Advice at Media
About the Zanubrutinib Analytic Balloon Program
Clinical trials of zanubrutinib include:
BeiGene is a global, commercial-stage, research-based biotechnology aggregation focused on molecularly-targeted and immuno-oncology blight therapeutics. With a aggregation of over 3,000 advisers in the United States, China, Australia, and Europe; BeiGene is advancing a activity consisting of atypical articulate baby molecules and monoclonal antibodies for cancer. BeiGene is additionally alive to actualize aggregate solutions aimed to accept both a allusive and abiding appulse on blight patients. In the United States, BeiGene markets and distributes BRUKINSA™ (zanubrutinib) and in China, the Aggregation markets ABRAXANE® (nanoparticle albumin–bound paclitaxel), REVLIMID® (lenalidomide), and VIDAZA® (azacitidine) beneath a authorization from Celgene Corporation.5
This columnist absolution contains advanced statements aural the acceptation of the Private Balance Litigation Reform Act of 1995 and added federal balance laws, including statements apropos BeiGene’s affairs and expectations for the commercialization of BRUKINSA, the abeyant implications of analytic abstracts for patients, BeiGene’s added advance of, and advancing analytic development, authoritative milestones and commercialization of BRUKINSA. Actual after-effects may alter materially from those adumbrated in the advanced statements as a aftereffect of assorted important factors, including BeiGene’s adeptness to authenticate the adeptness and assurance of its biologic candidates; the analytic after-effects for its biologic candidates, which may not abutment added development or business approval; accomplishments of authoritative agencies, which may affect the initiation, timing and advance of analytic trials and business approval; BeiGene’s adeptness to accomplish bartering success for its marketed articles and biologic candidates, if approved; BeiGene’s adeptness to access and advance aegis of bookish acreage for its technology and drugs; BeiGene’s assurance on third parties to conduct biologic development, accomplishment and added services; BeiGene’s bound operating history and BeiGene’s adeptness to access added allotment for operations and to complete the development and commercialization of its biologic candidates, as able-bodied as those risks added absolutely discussed in the area advantaged “Risk Factors” in BeiGene’s best contempo annual address on Anatomy 10-Q, as able-bodied as discussions of abeyant risks, uncertainties, and added important factors in BeiGene’s consecutive filings with the U.S. Balance and Exchange Commission. All advice in this columnist absolution is as of the date of this columnist release, and BeiGene undertakes no assignment to amend such advice unless adapted by law.
1 Media Contact
Liza Heapes or Vivian Ni
1 857-302-5663 or 1 Media BRUKINSA (zanubrutinib) Prescribing Information. Media BeiGene, Ltd; November 14, 2019.
2 Media Media Philip J. Bierman, James O. Armitage, in Goldman’s Cecil Medicine (Twenty Fourth Edition), 2012.
5 ABRAXANE®, REVLIMID® and VIDAZA® are registered trademarks of Celgene Corporation.
Photos accompanying this advertisement are accessible Media this advertisement are accessible Media Logo
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