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BEIJING, China and CAMBRIDGE, Mass., Dec. 22, 2019 (GLOBE NEWSWIRE) — BeiGene, 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 the China National Medical Articles Administration (NMPA) has accustomed a added new biologic appliance (sNDA) for REVLIMID® (lenalidomide), in aggregate with rituximab, for the analysis of patients with relapsed or adverse blah lymphoma (follicular lymphoma or bordering area lymphoma). REVLIMID was aboriginal accustomed in China in 2013 for the analysis of assorted myeloma in aggregate with dexamethasone, in developed patients who accept accustomed at atomic one above-mentioned therapy, and the characterization for the aggregate was broadcast in 2018 to accommodate developed patients with newly-diagnosed assorted myeloma (NDMM) who are not acceptable for transplant. It is currently marketed in China by BeiGene beneath an absolute authorization from Celgene Logistics Sarl, a Bristol-Myers Squibb company.
“This anniversary for REVLIMID marks accession footfall in the amplification of our hematology authorization into non-Hodgkin’s lymphoma (NHL) in China, area cogent unmet medical needs remain. Together with the awaiting approvals of tislelizumab for Hodgkin’s lymphoma and zanubrutinib for crimson corpuscle lymphoma and abiding lymphocytic leukemia as able-bodied as Revlimid for assorted myeloma, Vidaza for myelodysplastic syndromes and astute myeloid leukemia and added articles from the accord we accept appear with Amgen, we are alive to body a market-leading attendance in the analysis of hematological cancers in China,” said Dr. Xiaobin Wu, General Manager of China and President of BeiGene. “We are aflame about this befalling and attending advanced to alive carefully with Bristol-Myers Squibb and the NMPA to accompany this chemotherapy-free analysis advantage to patients with relapsed or adverse follicular lymphoma or bordering area lymphoma in China as anon as possible.”
The sNDA is accurate by a clinical, non-clinical, and chemistry, accomplishment and ascendancy (CMC) abstracts package, including the after-effects from the cardinal Phase 3 AUGMENT abstraction (NCT01938001) sponsored and conducted by Bristol-Myers Squibb. AUGMENT is a randomized, double-blind, multicenter balloon in which a absolute of 358 patients with relapsed or adverse follicular or bordering area lymphoma were randomized 1:1 to accept REVLIMID and rituximab (R2) or rituximab and placebo. With a average aftereffect of 28.3 months (range: 0.1 to 51.3 months), R2 accustomed clinically allusive and statistically cogent advance in progression-free adaptation (PFS), evaluated by an absolute analysis board (IRC), about to the ascendancy arm with a 54% abridgement in the accident of progression or afterlife (hazard arrangement [HR] = 0.46; 95% aplomb breach [CI]: 0.34, 0.62; p < 0.0001). The average PFS was 39.4 months for the R2 arm and 14.1 months for the ascendancy arm with an advance by added than 2 years. Overall acknowledgment amount (ORR), a accessory endpoint, was 78% in the R2 arm vs. 53% in the ascendancy arm, as adjourned by the IRC. Duration of acknowledgment (DoR) was decidedly bigger for R2 vs. ascendancy with average DoR of 37 vs. 22 months, appropriately (P =0.0015; HR: 0.53; 95% CI, 0.36-0.79). The best accepted adverse accident (AE) in the R2 arm was neutropenia (58%), vs. 22% in the ascendancy arm. Added frequently empiric AEs in added than 20% of patients included diarrhea (31% in the R2 arm vs. 23% in the ascendancy arm), ache (26% vs. 14%), ahem (23% vs. 17%), and fatigue (22% vs. 18%). Adverse contest that were appear at a college amount (>10%) in the R2 arm were neutropenia, constipation, leukopenia, anemia, thrombocytopenia and bump flare.
About follicular lymphoma (FL) and bordering area lymphoma (MZL)
FL and MZL are two above types of blah lymphomas;1 FL is the best accepted subtype, basic about 20% to 25% of all NHL,2 followed by MZL (approximately 5% to 17% of all NHLs).3 NHL accident in China is 88,090 according to the World Health Organization’s Globocan 2018 database.4 Accustomed the cureless attributes of relapsed or adverse FL/MZL, the adeptness and assurance limitations of accepted analysis options, and the actuality that patients are about earlier and with comorbidities, a aerial unmet medical charge exists for the development of atypical analysis options with new differentiated mechanisms of activity and a added tolerable assurance contour that can advance the affection of acknowledgment and PFS in the ambience of ahead advised FL/MZL.
In China, REVLIMID was accustomed in aggregate with dexamethasone for the analysis of developed patients with anew diagnosed assorted myeloma (MM) who are not acceptable for displace in 2018. It accustomed approval in China in 2013 for the analysis of assorted myeloma in aggregate with dexamethasone in developed patients who accept accustomed at atomic one above-mentioned therapy.
REVLIMID is accustomed in Europe and the United States as monotherapy, adumbrated for the aliment analysis of developed patients with anew diagnosed MM who accept undergone autologous axis corpuscle transplantation. REVLIMID as aggregate analysis is accustomed in Europe, in the United States, in Japan and in about 25 added countries for the analysis of developed patients with ahead basic MM who are not acceptable for transplant. REVLIMID is additionally accustomed in aggregate with dexamethasone for the analysis of patients with MM who accept accustomed at atomic one above-mentioned analysis in about 70 countries, encompassing Europe, the Americas, the Middle-East and Asia, and in aggregate with dexamethasone for the analysis of patients whose ache has progressed afterwards one analysis in Australia and New Zealand.
REVLIMID is additionally accustomed in the United States, Canada, Switzerland, Australia, New Zealand and several Latin American countries, as able-bodied as Malaysia and Israel, for transfusion-dependent anaemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a abatement 5q cytogenetic aberancy with or afterwards added cytogenetic abnormalities and in Europe for the analysis of patients with transfusion-dependent anemia due to low- or intermediate-1-risk MDS associated with an abandoned abatement 5q cytogenetic aberancy aback added ameliorative options are bereft or inadequate.
In addition, REVLIMID is accustomed in Europe for the analysis of patients with crimson corpuscle lymphoma (MCL) and in the United States for the analysis of patients with MCL whose ache has relapsed or progressed afterwards two above-mentioned therapies, one of which included bortezomib. In Switzerland, REVLIMID is adumbrated for the analysis of patients with relapsed or adverse MCL afterwards above-mentioned analysis that included bortezomib and chemotherapy/rituximab.
REVLIMID is not adumbrated and is not recommended for the analysis of patients with abiding lymphocytic leukemia (CLL) alfresco of controlled analytic trials.
U.S. Indications for REVLIMID®
REVLIMID® (lenalidomide) in aggregate with dexamethasone (dex) is adumbrated for the analysis of developed patients with assorted myeloma (MM).
REVLIMID is adumbrated as aliment analysis in developed patients with MM afterward autologous hematopoietic axis corpuscle transplantation (auto-HSCT).
REVLIMID is adumbrated for the analysis of developed patients with transfusion-dependent anemia due to low-or intermediate-1–risk myelodysplastic syndromes (MDS) associated with a abatement 5q cytogenetic aberancy with or afterwards added cytogenetic abnormalities.
REVLIMID is adumbrated for the analysis of developed patients with crimson corpuscle lymphoma (MCL) whose ache has relapsed or progressed afterwards two above-mentioned therapies, one of which included bortezomib.
REVLIMID in aggregate with a rituximab artefact is adumbrated for the analysis of developed patients with ahead advised follicular lymphoma (FL).
REVLIMID in aggregate with a rituximab artefact is adumbrated for the analysis of developed patients with ahead advised bordering area lymphoma (MZL).
REVLIMID is not adumbrated and is not recommended for the analysis of patients with abiding lymphocytic leukemia (CLL) alfresco of controlled analytic trials.
REVLIMID is alone accessible through a belted administration program, REVLIMID REMS®.
Important Assurance Information
WARNING: EMBRYO-FETAL TOXICITY, HEMATOLOGIC TOXICITY, and VENOUS and ARTERIAL THROMBOEMBOLISM
Do not use REVLIMID during pregnancy. Lenalidomide, a thalidomide analogue, acquired limb abnormalities in a adorning monkey study. Thalidomide is a accepted animal teratogen that causes astringent life-threatening animal bearing defects. If lenalidomide is acclimated during pregnancy, it may annual bearing defects or embryo-fetal death. In females of changeable potential, access 2 abrogating abundance tests afore starting REVLIMID treatment. Females of changeable abeyant charge use 2 forms of contraception or continuously abjure from heterosexual sex during and for 4 weeks afterwards REVLIMID treatment. To abstain embryo-fetal acknowledgment to lenalidomide, REVLIMID is alone accessible through a belted administration program, the REVLIMID REMS® program.
Information about the REVLIMID REMS affairs is accessible at www.celgeneriskmanagement.com or by calling the manufacturer’s toll-free cardinal 1-888-423-5436.
Hematologic Toxicity (Neutropenia and Thrombocytopenia)
REVLIMID can annual cogent neutropenia and thrombocytopenia. Eighty percent of patients with del 5q MDS had to accept a dosage delay/reduction during the above study. Thirty-four percent of patients had to accept a added dosage delay/reduction. Grade 3 or 4 hematologic toxicity was apparent in 80% of patients enrolled in the study. Patients on analysis for del 5q MDS should accept their complete claret counts monitored annual for the aboriginal 8 weeks of analysis and at atomic annual thereafter. Patients may crave dosage abeyance and/or reduction. Patients may crave use of claret artefact abutment and/or advance factors.
Venous and Arterial Thromboembolism
REVLIMID has accustomed a decidedly added accident of abysmal attitude occlusion (DVT) and pulmonary array (PE), as able-bodied as accident of myocardial infarction and achievement in patients with MM who were advised with REVLIMID and dexamethasone therapy. Adviser for and admonish patients about signs and affection of thromboembolism. Admonish patients to seek actual medical affliction if they advance affection such as conciseness of breath, chest pain, or arm or leg swelling. Thromboprophylaxis is recommended and the best of dieting should be based on an appraisal of the patient’s basal risks.
Pregnancy: REVLIMID can annual fetal abuse aback administered to a abundant changeable and is contraindicated in females who are pregnant. If this biologic is acclimated during abundance or if the accommodating becomes abundant while demography this drug, the accommodating should be acquainted of the abeyant accident to the fetus.
Severe Hypersensitivity Reactions: REVLIMID is contraindicated in patients who accept accustomed astringent hypersensitivity (e.g., angioedema, Stevens-Johnson syndrome, baneful epidermal necrolysis) to lenalidomide.
WARNINGS AND PRECAUTIONS
Embryo-Fetal Toxicity: See Boxed WARNINGS.
REVLIMID REMS® Program: See Boxed WARNINGS. Prescribers and pharmacies charge be certified with the REVLIMID REMS affairs by enrolling and acknowledging with the REMS requirements; pharmacies charge alone allocate to patients who are accustomed to accept REVLIMID. Patients charge assurance a Patient-Physician Agreement Form and accede with REMS requirements; changeable patients of changeable abeyant who are not abundant charge accede with the abundance testing and contraception requirements and males charge accede with contraception requirements.
Hematologic Toxicity: REVLIMID can annual cogent neutropenia and thrombocytopenia. Adviser patients with neutropenia for signs of infection. Admonish patients to beam for bleeding or bruising, abnormally with use of accessory medications that may access accident of bleeding. Patients may crave a dosage abeyance and/or dosage reduction. MM: Adviser complete claret counts (CBC) in patients demography REVLIMID dexamethasone or REVLIMID as aliment therapy, every 7 canicule for the aboriginal 2 cycles, on canicule 1 and 15 of aeon 3, and every 28 canicule thereafter. MDS: Adviser CBC in patients on analysis for del 5q MDS, annual for the aboriginal 8 weeks of analysis and at atomic annual thereafter. See Boxed WARNINGS for added information. MCL: Adviser CBC in patients demography REVLIMID for MCL annual for the aboriginal aeon (28 days), every 2 weeks during cycles 2-4, and again annual thereafter. FL/MZL: Adviser CBC in patients demography REVLIMID for FL or MZL annual for the aboriginal 3 weeks of Aeon 1 (28 days), every 2 weeks during Cycles 2-4, and again annual thereafter.
Venous and Arterial Thromboembolism: See Boxed WARNINGS. Venous thromboembolic contest (DVT and PE) and arterial thromboses (MI and CVA) are added in patients advised with REVLIMID. Patients with accepted accident factors, including above-mentioned thrombosis, may be at greater accident and accomplishments should be taken to try to abbreviate all adjustable factors (e.g., hyperlipidemia, hypertension, smoking). Thromboprophylaxis is recommended and the dieting should be based on the patient’s basal risks. ESAs and estrogens may added access the accident of occlusion and their use should be based on a benefit-risk decision.
Increased Bloodshed in Patients With CLL: In a analytic balloon in the first-line analysis of patients with CLL, single-agent REVLIMID analysis added the accident of afterlife as compared to single-agent chlorambucil. Austere adverse cardiovascular reactions, including atrial fibrillation, myocardial infarction, and cardiac failure, occurred added frequently in the REVLIMID arm. REVLIMID is not adumbrated and not recommended for use in CLL alfresco of controlled analytic trials.
Second Primary Malignancies (SPM): In analytic trials in patients with MM accepting REVLIMID and in patients with FL or MZL accepting REVLIMID rituximab therapy, an access of hematologic added solid bump SPM, conspicuously AML, accept been observed. In patients with MM, MDS was additionally observed. Adviser patients for the development of SPM. Booty into annual both the abeyant account of REVLIMID and accident of SPM aback because treatment.
Increased Bloodshed With Pembrolizumab: In analytic trials in patients with MM, the accession of pembrolizumab to a thalidomide alternation added dexamethasone resulted in added mortality. Analysis of patients with MM with a PD-1 or PD-L1 blocking antibiotic in aggregate with a thalidomide alternation added dexamethasone is not recommended alfresco of controlled analytic trials.
Hepatotoxicity: Hepatic failure, including baleful cases, has occurred in patients advised with REVLIMID dexamethasone. Pre-existing viral alarmist disease, animated baseline alarmist enzymes, and accessory medications may be accident factors. Adviser alarmist enzymes periodically. Stop REVLIMID aloft acclivity of alarmist enzymes. Afterwards acknowledgment to baseline values, analysis at a lower dosage may be considered.
Severe Cutaneous Reactions: Astringent cutaneous reactions including Stevens-Johnson affection (SJS), baneful epidermal necrolysis (TEN), and biologic acknowledgment with eosinophilia and systemic affection (DRESS) accept been reported. These contest can be fatal. Patients with a above-mentioned history of Grade 4 adventurous associated with thalidomide analysis should not accept REVLIMID. Consider REVLIMID abeyance or cessation for Grade 2-3 bark rash. Permanently abandon REVLIMID for Grade 4 rash, exfoliative or bullous rash, or for added astringent cutaneous reactions such as SJS, TEN, or DRESS.
Tumor Lysis Affection (TLS): Baleful instances of TLS accept been appear during analysis with REVLIMID. The patients at accident of TLS are those with aerial bump accountability above-mentioned to treatment. Carefully adviser patients at accident and booty adapted antitoxin approaches.
Tumor Blaze Acknowledgment (TFR): TFR has occurred during investigational use of REVLIMID for CLL and lymphoma. Ecology and appraisal for TFR is recommended in patients with MCL, FL, or MZL. Bump blaze may actor the progression of ache (PD). In patients with Grade 3 or 4 TFR, it is recommended to abstain analysis with REVLIMID until TFR resolves to ≤Grade 1. REVLIMID may be connected in patients with Grade 1 and 2 TFR afterwards abeyance or modification, at the physician’s discretion.
Impaired Axis Corpuscle Mobilization: A abatement in the cardinal of CD34 beef calm afterwards analysis (>4 cycles) with REVLIMID has been reported. Consider aboriginal barometer to displace centermost to optimize timing of the axis corpuscle collection.
Thyroid Disorders: Both hypothyroidism and hyperthyroidism accept been reported. Measure thyroid action afore starting REVLIMID analysis and during therapy.
Early Bloodshed in Patients With MCL: In accession MCL study, there was an access in aboriginal deaths (within 20 weeks); 12.9% in the REVLIMID arm against 7.1% in the ascendancy arm. Accident factors for aboriginal deaths accommodate aerial bump burden, MIPI account at diagnosis, and aerial WBC at baseline (≥10 x 109/L).
Hypersensitivity: Hypersensitivity, including angioedema, anaphylaxis, and anaphylactic reactions to REVLIMID has been reported. Permanently abandon REVLIMID for angioedema and anaphylaxis.
Mantle Corpuscle Lymphoma
Follicular Lymphoma/Marginal Area Lymphoma
Periodically adviser digoxin claret levels due to added Cmax and AUC with accessory REVLIMID therapy. Patients demography accessory therapies such as erythropoietin-stimulating agents or estrogen-containing therapies may accept an added accident of thrombosis. It is not accepted whether there is an alternation amid dexamethasone and warfarin. Close ecology of PT and INR is recommended in patients with MM demography accessory warfarin.
USE IN SPECIFIC POPULATIONS
Please see abounding Prescribing Information, including Boxed WARNINGS, for REVLIMID.
Please see the rituximab abounding Prescribing Advice for Important Assurance Advice at www.rituxan.com.
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® (paclitaxel for bang [albumin bound]), REVLIMID® (lenalidomide), and VIDAZA® (azacitidine) beneath a authorization from Celgene Logistics Sarl, a Bristol-Myers Squibb company.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 added development and commercialization of REVLIMID in China and the abeyant implications for patients. 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 Form 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 appropriate by law.
______________________1 Bello C, Zhang L, Naghashpour M. Follicular lymphoma: accepted administration and approaching directions. Blight Control. 2012;19:187-95.
2 Sousou T, Friedberg J. Rituximab in blah lymphomas. Semin Hematol. 2010; 47(2):133-42.
3 Zinzani, P. L. (2012). The abounding faces of bordering area lymphoma. Hematology, 2012(1), 426–432.
5 ABRAXANE® is registered brand of Abraxis Bioscience LLC, a Bristol-Myers Squibb company; REVLIMID® and VIDAZA® are registered trademarks of Celgene Corporation, a Bristol-Myers Squibb company.
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