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Indications","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"April 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Johnson & Johnson Innovative Medicine","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"NICE Gives Green Light to Ibrutinib Plus Venetoclax as First-Line Treatment Option for Chronic Lymphocytic Leukaemia","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"April 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Bristol Myers Squibb","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"U.S. Food and Drug Administration Accepts for Priority Review Bristol Myers Squibb\u2019s Application for Breyanzi (lisocabtagene maraleucel) for Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"Approved","date":"November 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Curis","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Curis Announces Initial Combination Study Data from its TakeAim Lymphoma Study","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"December 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Pharmacyclics","sponsor":"Johnson & Johnson Innovative 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Find Clinical Drug Pipeline Developments & Deals for Ibrutinib
Imbruvica (ibrutinib) is the only Bruton’s tyrosine kinase inhibitor (BTKi) approved with an oral suspension formulation, which is indicated for the treatment of chronic lymphocytic leukemia, Waldenström's macroglobulinemia & chronic graft versus host disease.
SYMPATICO Trial of Ibrutinib Plus Venetoclax Boosts PFS in MCL
Details:
Imbruvica (ibrutinib) is a USFDA approved Bruton’s tyrosine kinase inhibitor. It is being evaluated in combination with venetoclax for the treatment of relapsed/refractory mantle cell lymphoma.
Imbruvica (ibrutinib) is a USFDA approved Bruton’s tyrosine kinase inhibitor. It is being evaluated in combination with venetoclax for the treatment of chronic lymphocytic leukemia.
The disappointed outcome of the confirmatory trials leads to voluntarily withdraw, in the U.S., accelerated IMBRUVICA® (ibrutinib) approvals for patients with the blood cancers mantle cell lymphoma who have received at least one prior therapy and with marginal zone lymphoma.
The sNDA and NDA submissions were primarily based on results of three years of data from the Phase 1/2 iMAGINE clinical trial for Imbruvica (ibrutinib), blocks the BTK protein which showed an ORR of 78 percent and PK data was consistent with adult dosing of IMBRUVICA.
Ibrutinib plus venetoclax is an investigational fixed-duration combination. Patients received 3 cycles of ibrutinib lead-in followed by 12 cycles of ibrutinib + venetoclax (Ibr 420 mg/day PO; Ven ramp up to 400 mg/day PO).
Latest data from the CAPTIVATE study underscore that IMBRUVICA in an all-oral fixed-duration combination with venetoclax also delivers a high rate of progression-free survival at two years while enabling treatment-free remission for patients.
Updates are based on more than five years of Phase 3 iNNOVATE final analysis data, which demonstrated IMBRUVICA plus rituximab significantly prolonged progression-free survival (PFS) versus rituximab alone in adults with WM.
AbbVie will present updated results from the CAPTIVATE study, evaluating disease-free survival in previously untreated patients with chronic lymphocyctic leukemia/small lymphocytic leukemia who received ibrutinib (IMBRUVICA®) + venetoclax (VENCLEXTA®/ VENCLYXTO®) regimen.
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