Us Fda Grants Accelerated Approval To Janssens Rybrevant To Treat Nsclc With Egfr Exon 20 Insertion Mutations

The Janssen Pharmaceutical Companies Of Johnson &Amp; Johnson Announced The Us Food And Drug Administration (Fda) Has Granted The Accelerated Approval Of Rybrevant (Amivantamab-Vmjw) For The Treatment Of Adult Patients With Locally Advanced Or Metastatic Non-Small Cell Lung Cancer (Nsclc) With Epidermal Growth Factor Receptor (Egfr) Exon 20 Insertion Mutations, As Detected By An Fda-Approved Test, Whose Disease Has Progressed On Or After Platinum-Based Chemotherapy.Rybrevant Is The First Fully-Human, Bispecific Antibody Approved For The Treatment Of Patients With Nsclc That Targets Egfr Exon 20 Insertion Mutations, Which Are The Third Most Prevalent Activating Egfr Mutation. Today&Rsquo;S Approval Follows The Fda&Rsquo;S Decision To Grant Breakthrough Therapy Designation (Btd) In March 2020 And To Initiate A Priority Review Of The Biologics License Application (Bla) In December 2020. This Indication Is Approved Under Accelerated Approval Based On Overall Response Rate And Duration Of Response. Continued Approval For This Indication May Be Contingent Upon Verification And Description Of Clinical Benefit In The Confirmatory Trials.1&Ldquo;Today&Rsquo;S Fda Approval Is An Important Development For People Living With Non-Small Cell Lung Cancer With Exon 20 Insertion Mutations Who, Until Now, Have Had No Approved Treatment Options To Target Their Disease,&Rdquo; Said Jill Feldman, Co-Founder Of The Egfr Resisters, An Advocacy Organization Patient Group, And A Lung Cancer Patient Advocate. &Ldquo;We Are Excited By The Promise This New Treatment Option Brings To People With This Particular Type Of Lung Cancer And Their Families.&Rdquo;Lung Cancer Is The Leading Cause Of Cancer Death Among Both Men And Women, Accounting For Almost 25 Percent Of All Cancer Deaths. Currently Available Targeted Treatments, Like Egfr Tyrosine Kinase Inhibitors (Tki) Are Generally Insensitive In Treating Nsclc Driven By Egfr Exon 20 Insertion Mutations And Are Not Fda-Approved For These Patients. In Addition, Nsclc Driven By This Mutation Carries A Worse Prognosis And Shorter Survival Rates Compared With Lung Cancer Driven By More Common Egfr Mutations, Such As Exon 19 Deletions And L858R Substitutions. Patients Newly Diagnosed With Metastatic Nsclc With Egfr Exon 20 Insertion Mutations Have A Real-World Median Overall Survival (Os) Of 16.2 Months (95 Per Cent Confidence Interval [Ci], 11.0 &Ndash; 19.4), Which Is Lower Than Patients With Egfr Exon 19 Deletions/L858R Mutations, Who Have A Real-World Median Os Of 25.5 Months (95 Per Cent Ci, 24.5 &Ndash; 27.0).&Ldquo;Lung Cancer Is A Complex Disease, And Through The Study And Deeper Understanding Of Genetic Alterations Like Egfr Exon 20 Insertion Mutations, We Are Able To Target The Disease In New Ways And Improve Treatment Outcomes For Patients,&Rdquo; Said Joshua K. Sabari, M.D., New York University Langone&Rsquo;S Perlmutter Cancer Center And Study Investigator, Who Presented The Latest Clinical Trial Results At The International Association For The Study Of Lung Cancer&Rsquo;S (Iaslc Wclc) 2020 World Conference On Lung Cancer Singapore. &Ldquo;Amivantamab-Vmjw Is An Innovative Bispecific Antibody That Brings An Important New Therapeutic Approach To Physicians Caring For Patients With This Serious And Rare Type Of Lung Cancer.&Rdquo;Rybrevant Is A Fully-Human Bispecific Antibody Directed Against Egfr And Met Receptors.1 Rybrevant Binds Extracellularly (Outside Of The Cell) Inhibiting Tumor Growth And Leading To Tumor Cell Death.1 Today&Rsquo;S Accelerated Fda Approval Is Based On Positive Results From The Phase 1 Chrysalis Study, A Multicenter, Open-Label, Clinical Study Evaluating Rybrevant As A Monotherapy In Patients Enrolled In The Prior Platinum Containing Chemotherapy Cohort. Initial Results From The Chrysalis Egfr Exon 20 Insertion Mutation Population, Which Supported The Btd, Were Presented At The American Society Of Clinical Oncology 2020 Virtual Scientific Program, And Updated Results Were Presented At The Iaslc Wclc 2020.&Ldquo;The Approval Of Rybrevant, Along With The Companion Diagnostic Test, Addresses High Unmet Need In The Treatment Of People With Genetically Defined Non-Small Cell Lung Cancer,&Rdquo; Said Peter Lebowitz, M.D., Ph.D., Global Therapeutic Area Head, Oncology, Janssen Research &Amp; Development, Llc. &Ldquo;At Janssen, We Are Committed To The Development Of Innovative Therapies Like Rybrevant And Believe That Advancing Medicines Targeting Specific Pathways Can Bring The Greatest Benefits And Improve Outcomes For Patients With Tumor Alterations Such As Egfr And Met.&Rdquo;The Fda Simultaneously Approved Guardant Health&Rsquo;S Guardant360 Cdx Liquid Biopsy Blood Test As A Companion Diagnostic For Use With Rybrevant.Next-Generation Sequencing Tests Offer An Alternative To Polymerase Chain Reaction (Pcr)-Based Tests Which Fail To Identify 50 Per Cent Or More Of Exon 20 Insertion Mutations.&Ldquo;Today&Rsquo;S Milestone Reflects Progress And Determination In Our Mission To Develop And Deliver Transformational Therapies To Improve The Lives Of People Diagnosed With Some Of The Most Devastating And Complex Diseases Of Our Time,&Rdquo; Said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research &Amp; Development, Johnson &Amp; Johnson. &Ldquo;The Approval Of Rybrevant, The First Lung Cancer Treatment For Johnson &Amp; Johnson, Strengthens Our Commitment To Harness Science, Expertise And Scale To Dramatically Alter The Trajectory Of Lung Cancer, And Reduce The Impact Of The World&Rsquo;S Leading Cause Of Cancer Mortality.&Rdquo;Rybrevant Is Being Studied In A Comprehensive Clinical Development Program For People With Untreated Advanced Egfr-Mutated Nsclc, Including The Phase 3 Mariposa (Nct04487080) Trial Studying Rybrevant In Combination With Lazertinib, Another Phase 3 Trial, Papillon (Nct04538664), Is Studying Rybrevant In Combination With Carboplatin-Pemetrexed For People With Advanced Or Metastatic Egfr-Mutated Nsclc With Exon 20 Insertion Mutations. Rybrevant Received Us Fda Btd In March 2020 And Priority Review Designation Following The Bla Announcement In December 2020. Janssen Has Filed Regulatory Submissions For Rybrevant With Health Authorities In Europe And Other Markets.

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