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Review

Rituximab in the treatment of follicular lymphoma: the future of biosimilars in the evolving therapeutic landscape

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Pages 131-140 | Published online: 24 Apr 2017

References

  • Cancer ResearchUKNon-Hodgkin lymphoma incidence statisticsLondonCancer Research UK2011 Available from: http://www.cancerresearchuk.org/cancer-info/cancerstats/types/nhl/incidence/uk-nonhodgkin-lymphoma-incidence-statistics#worldAccessed August 5, 2016
  • FerlayJSoerjomataramIErvikMGLOBOCAN 2012 v1.0, Cancer incidence and mortality worldwide: IARC CancerBase No. 11LyonInternational Agency for Research on Cancer2013 [updated October 9, 2014]. Available from: http://globocan.iarc.frAccessed August 5, 2016
  • Union for International Cancer ControlFollicular lymphoma Union for International Cancer Control, 2014 review of cancer medicines on the WHO list of essential medicines Executive summaryGenevaWorld Health Organization2014 Available from: http://www.who.int/selection_medicines/committees/expert/20/applications/FollicularLymphoma.pdfAccessed August 5, 2016
  • Solal-CélignyPRoyPColombatPFollicular lymphoma international prognostic indexBlood200410451258126515126323
  • StashenkoPNadlerLMHardyRSchlossmanSFCharacterization of a human B lymphocyte-specific antigenJ Immunol19801254167816856157744
  • Genentech IncRituxan (rituximab) injection prescribing informationSouth San Francisco, CAGenentech Inc1997 [updated April 2016]. Available from: http://www.gene.com/download/pdf/rituxan_prescribing.pdfAccessed August 5, 2016
  • RocheMabThera 100 mg and 500 mg concentrate for solution for infusion. eMC+2014 [updated May 26, 2016]. Available from: http://www.medicines.org.uk/emc/medicine/2570/SPC/Mabthera+100mg+and+500mg+concentrate+for+solution+for+infusionAccessed August 5, 2016
  • National Comprehensive Cancer NetworkNCCN clinical practice guidelines in oncology. B-cell Lymphomas. Version 12017Fort Washington, PANCCN2017 [updated 2017]. Available from: https://www.nccn.org/professionals/physician_gls/pdf/b-cell.pdfAccessed February 9, 2017
  • DreylingMGhielminiMMarcusRSallesGVitoloULadettoMESMO Guidelines Working GroupNewly diagnosed and relapsed follicular lymphoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-upAnn Oncol201425Suppl 3iii76iii8225122695
  • CzuczmanMSGregorySAThe future of CD20 monoclonal antibody therapy in B-cell malignanciesLeuk Lymphoma201051698399420367564
  • Mac ManusMPHoppeRTIs radiotherapy curative for stage I and II low-grade follicular lymphoma? Results of a long-term follow-up study of patients treated at Stanford UniversityJ Clin Oncol1996144128212908648385
  • WilderRBJonesDTuckerSLLong-term results with radiotherapy for Stage I–II follicular lymphomasInt J Radiat Oncol Biol Phys20015151219122711728680
  • PughTJBallonoffANewmanFRabinovitchRImproved survival in patients with early stage low-grade follicular lymphoma treated with radiation: a Surveillance, Epidemiology, and End Results database analysisCancer2010116163843385120564102
  • ArdeshnaKMSmithPNortonABritish National Lymphoma InvestigationLong-term effect of a watch and wait policy versus immediate systemic treatment for asymptomatic advanced-stage non-Hodgkin lymphoma: a randomised controlled trialLancet2003362938351652212932382
  • ArdeshnaKMQianWSmithPRituximab versus a watch-and-wait approach in patients with advanced-stage, asymptomatic, non-bulky follicular lymphoma: an open-label randomised phase 3 trialLancet Oncol201415442443524602760
  • BricePBastionYLepageEComparison in low-tumor-burden follicular lymphomas between an initial no-treatment policy, prednimustine, or interferon alfa: a randomized study from the Groupe d’Etude des Lymphomes Folliculaires. Groupe d’Etude des Lymphomes de l’AdulteJ Clin Oncol1997153111011179060552
  • FlinnIWvan der JagtRKahlBSRandomized trial of bendamustine-rituximab or R-CHOP/R-CVP in first-line treatment of indolent NHL or MCL: the BRIGHT studyBlood2014123192944295224591201
  • RummelMJNiederleNMaschmeyerGStudy group indolent Lymphomas (StiL)Bendamustine plus rituximab versus CHOP plus rituximab as first-line treatment for patients with indolent and mantle-cell lymphomas: an open-label, multicentre, randomised, phase 3 non-inferiority trialLancet201338198731203121023433739
  • SallesGSeymourJFOffnerFRituximab maintenance for 2 years in patients with high tumour burden follicular lymphoma responding to rituximab plus chemotherapy (PRIMA): a phase 3, randomised controlled trialLancet20113779759425121176949
  • KahlBSHongFWilliamsMERituximab extended schedule or re-treatment trial for low-tumor burden follicular lymphoma: Eastern Cooperative Oncology Group Protocol e4402J Clin Oncol201432283096310225154829
  • Janssen Biotech, IncImbruvica prescribing informationHorsham, PAJanssen Biotech, Inc2016 [updated June 2016]. Available from: http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205552Orig1s012lbl.pdfAccessed December 5, 2016
  • National Cancer InstituteFDA approval for ibrutinib (Imbruvica): approved for chronic lymphocytic leukemia after previous treatmentBethesda, MDUS Department of Health and Human Services2013 [updated April 8, 2015]. Available from: http://www.cancer.gov/about-cancer/treatment/drugs/fda-ibrutinibAccessed August 5, 2016
  • Janssen-Cilag International NVIMBRUVICA 140 mg hard capsules. eMC+2014 [updated October 21, 2014]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/003791/WC500177775.pdfAccessed December 5, 2016
  • FoodUSAdministrationDrugFDA approves Zydelig for three types of blood cancers [FDA news release]Silver Spring, MDUS Department of Health and Human Services2014 [updated July 23, 2014]. Available from: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm406387.htmAccessed August 5, 2016
  • Genentech IncGazyva prescribing informationSouth San Francisco, CAGenentech Inc2016 [updated February 2016]. Available from: https://www.gene.com/download/pdf/gazyva_prescribing.pdfAccessed December 5, 2016
  • SehnLHChuaNMayerJObinutuzumab plus bendamustine versus bendamustine monotherapy in patients with rituximab-refractory indolent non-Hodgkin lymphoma (GADOLIN): a randomised, controlled, open-label, multicentre, phase 3 trialLancet Oncol20161781081109327345636
  • RadfordJDaviesACartronGObinutuzumab (GA101) plus CHOP or FC in relapsed/refractory follicular lymphoma: results of the GAUDI study (BO21000)Blood201312271137114323843495
  • MarcusREDaviesAJAndoKObinutuzumab-based induction and maintenance prolongs progression-free survival (PFS) in patients with previously untreated follicular lymphoma: primary results of the randomized phase 3 GALLIUM studyPoster presented at: American Society of Hematology (ASH)December 3–6, 2016Washington, DC
  • SehnLHAssoulineSEStewartDAA phase 1 study of obinutuzumab induction followed by 2 years of maintenance in patients with relapsed CD20-positive B-cell malignanciesBlood2012119225118512522438256
  • SallesGMorschhauserFLamyTPhase 1 study results of the type II glycoengineered humanized anti-CD20 monoclonal anti-body obinutuzumab (GA101) in B-cell lymphoma patientsBlood2012119225126513222431570
  • CelgeneRevlimid prescribing informationSummit, NJCelgene2015 [updated February 2015]. Available from: http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021880s041lbl.pdfAccessed December 5, 2016
  • FowlerNHDavisRERawalSSafety and activity of lenalidomide and rituximab in untreated indolent lymphoma: an open-label, phase 2 trialLancet Oncol201415121311131825439689
  • VitalEMKayJEmeryPRituximab biosimilarsExpert Opin Biol Ther20131371049106223600760
  • BaerWHMainiAJacobsIBarriers to the access and use of rituximab in patients with non-Hodgkin’s lymphoma and chronic lymphocytic leukemia: a physician surveyPharmaceuticals (Basel)20147553054424810947
  • LiESubramanianJAndersonSThomasDMcKinleyJJacobsIADevelopment of biosimilars in an era of oncologic drug shortagesDrug Des Devel Ther2015932473255
  • GogineniKShumanKLEmanuelEJSurvey of oncologists about shortages of cancer drugsN Engl J Med2013369252463246424350971
  • WeiseMBielskyMCDe SmetKBiosimilars: what clinicians should knowBlood2012120265111511723093622
  • FoodUSAdministrationDrugScientific considerations in demonstrating biosimilarity to a reference product: guidance for industrySilver Spring, MDU.S. Department of Health and Human Services, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER)2015 [updated April 2015]. Available from: http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdfAccessed August 5, 2016
  • European Medicines AgencyGuideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issuesLondonEuropean Medicines Agency2015 [updated December 18, 2014]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2015/01/WC500180219.pdfAccessed August 5, 2016
  • European Medicines AgencyEuropean public assessment reports (EPAR) for human medicines: biosimilarsLondonEuropean Medicines Agency2016 Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/landing/epar_search.jsp&mid=WC0b01ac058001d125Accessed June 21, 2016
  • Sandoz, IncZarxio (filgrastim-sndz) injection prescribing informationPrinceton, NJSandoz, Inc2015 [updated March 20, 2015]. Available from: http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125553lbl.pdfAccessed August 5, 2016
  • US Food and Drug AdministrationFilgrastim-sndzSilver Spring, MDUS Department of Health and Human Services, US Food and Drug Administration2015 [updated March 6, 2015]. Available from: http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm436953.htmAccessed August 5, 2016
  • Expert Committee on Biological StandardizationGuidelines on evaluation of similar biotherapeutic products (SBPs)GenevaWorld Health Organization2009 [updated October 19–21, 2009]. Available from: http://www.who.int/biologicals/areas/biological_therapeutics/BIOTHERAPEUTICS_FOR_WEB_22APRIL2010.pdfAccessed August 5, 2016
  • Generics and Biosimilars Initiative (GaBI)Biosimilar rituximab approved in South Korea. GaBI online2016 [updated December 2, 2016]. Available from: http://gabionline.net/Biosimilars/News/Biosimilar-rituximab-approved-in-South-KoreaAccessed December 5, 2016
  • CoiffierBSanchoJMJurczakWPharmacokinetic and safety of CT-P10, a biosimilar candidate to the rituximab reference product, in patients with newly diagnosed advanced stage follicular lymphoma (AFL)Poster presented at: American Society of Hematology (ASH)December 3–6, 2016Washington, DC
  • YooDHSuhCHShimSCA multicentre randomised controlled trial to compare the pharmacokinetics, efficacy and safety of CT-P10 and innovator rituximab in patients with rheumatoid arthritisAnn Rheum Dis201776356657027624791
  • JurczakWIlidiaMGovindbabuKSA phase III efficacy and safety study of the proposed rituximab biosimilar GP2013 versus rituximab in patients with previously untreated advanced follicular lymphomaPoster presented at: American Society of Hematology (ASH)December 3–6, 2016Washington, DC
  • KarnikSThompsonMSDeGruttolaHCharacterization and comparison of PF-05280586—a proposed rituximab biosimilar to the licensed productPoster presented at: American Association of Pharmaceutical Scientists-National Biotechnology Conference (AAPS-NBC 2013)May 20–22, 2013San Diego, CA
  • BeckerJCMeliaLAGumbinerBThomasDSpencer-GreenGMengXA phase I trial comparing PF-05280586 (a potential biosimilar) and rituximab in subjects with active rheumatoid arthritisPoster presented at: 2014 American College of Rheumatology/Association of Rheumatology Health Professionals (ACR/ARHP) Annual Scientific MeetingNovember 15–19, 2014Boston, MA
  • GhielminiMSchmitzSFCogliattiSBProlonged treatment with rituximab in patients with follicular lymphoma significantly increases event-free survival and response duration compared with the standard weekly × 4 scheduleBlood2004103124416442314976046
  • van OersMHVan GlabbekeMGiurgeaLRituximab maintenance treatment of relapsed/resistant follicular non-Hodgkin’s lymphoma: long-term outcome of the EORTC 20981 phase III randomized intergroup studyJ Clin Oncol201028172853285820439641
  • ForstpointnerRUnterhaltMDreylingMGerman Low Grade Lymphoma Study Group (GLSG)Maintenance therapy with rituximab leads to a significant prolongation of response duration after salvage therapy with a combination of rituximab, fludarabine, cyclophosphamide, and mitoxantrone (R-FCM) in patients with recurring and refractory follicular and mantle cell lymphomas: results of a prospective randomized study of the German Low Grade Lymphoma Study Group (GLSG)Blood2006108134003400816946304
  • CzuczmanMSWeaverRAlkuzwenyBBerlfeinJGrillo-LópezAJProlonged clinical and molecular remission in patients with low-grade or follicular non-Hodgkin’s lymphoma treated with rituximab plus CHOP chemotherapy: 9-year follow-upJ Clin Oncol200422234711471615483015
  • HiddemannWKnebaMDreylingMFrontline therapy with rituximab added to the combination of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) significantly improves the out-come for patients with advanced-stage follicular lymphoma compared with therapy with CHOP alone: results of a prospective randomized study of the German Low-Grade Lymphoma Study GroupBlood2005106123725373216123223
  • McLaughlinPGrillo-LópezAJLinkBKRituximab chimeric anti-CD20 monoclonal antibody therapy for relapsed indolent lymphoma: half of patients respond to a four-dose treatment programJ Clin Oncol1998168282528339704735
  • MarcusRImrieKSolal-CelignyPPhase III study of R-CVP compared with cyclophosphamide, vincristine, and prednisone alone in patients with previously untreated advanced follicular lymphomaJ Clin Oncol200826284579458618662969
  • MorschhauserFRadfordJVan HoofAPhase III trial of consolidation therapy with yttrium-90-ibritumomab tiuxetan compared with no additional therapy after first remission in advanced follicular lymphomaJ Clin Oncol200826325156516418854568
  • MorschhauserFRadfordJVan HoofA90Yttrium-ibritumomab tiuxetan consolidation of first remission in advanced-stage follicular non-Hodgkin lymphoma: updated results after a median follow-up of 7.3 years from the International, Randomized, Phase III First-Line Indolent trialJ Clin Oncol201331161977198323547079
  • HagenbeckARadfordJVan HoofA90Y-Ibritumomab tiuxetan (Zevalin®) consolidation of first remission in advanced-stage follicular non-Hodgkin’s lymphoma: updated results after a median follow-up of 66.2 months from the International, Randomized, Phase III First-Line Indolent Trial (FIT) in 414 patientsBlood2010116 Suppl abstr 594
  • LeonardJJungSHJohnsonJLCALGB 50401: a randomized trial of lenalidomide alone versus lenalidomide plus rituximab in patients with recurrent follicular lymphomaJ Clin Oncol201230Suppl abstr 8000
  • WitzigTEFlinnIWGordonLITreatment with ibritumomab tiuxetan radioimmunotherapy in patients with rituximab-refractory follicular non-Hodgkin’s lymphomaJ Clin Oncol200220153262326912149300
  • HainsworthJDLitchySBurrisHA3rdRituximab as first-line and maintenance therapy for patients with indolent non-Hodgkin’s lymphomaJ Clin Oncol200220204261426712377971
  • ColombatPSallesGBrousseNRituximab (anti-CD20 mono-clonal antibody) as single first-line therapy for patients with follicular lymphoma with a low tumor burden: clinical and molecular evaluationBlood200197110110611133748
  • MartinelliGSchmitzSFUtigerULong-term follow-up of patients with follicular lymphoma receiving single-agent rituximab at two different schedules in trial SAKK 35/98J Clin Oncol201028294480448420697092
  • GopalAKKahlBSde VosSPI3Kδ inhibition by idelalisib in patients with relapsed indolent lymphomaN Engl J Med2014370111008101824450858
  • MartinPJungSHJohnsonJLCALGB 50803 (Alliance): a phase II trial of lenalidomide plus rituximab in patients with previously untreated follicular lymphomaJ Clin Oncol201432Suppl 5 abstr 8521
  • CzuczmanMSKoryznaAMohrARituximab in combination with fludarabine chemotherapy in low-grade or follicular lymphomaJ Clin Oncol200523469470415681517
  • McLaughlinPHagemeisterFBRodriguezMASafety of fludarabine, mitoxantrone, and dexamethasone combined with rituximab in the treatment of stage IV indolent lymphomaSemin Oncol2000276 Suppl 123741
  • FeuerleinKZuccaEGhielminiMFirst-line treatment of follicular lymphoma: a patient-oriented algorithmLeuk Lymphoma200950332533419229730