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Janssen Receives Positive CHMP Opinion for IMBRUVICA® (ibrutinib) in a Fixed-Duration Combination Regimen for Adult Patients with Previously Untreated Chronic Lymphocytic Leukaemia (CLL)
The positive opinion is based on Phase 3 GLOW and Phase 2 CAPTIVATE study results, which investigated the efficacy and safety of ibrutinib plus venetoclax in patients with previously untreated CLL[1],[2] If approved, this will be the first all-oral, once daily, fixed-duration, combination regimen for first-line treatment of CLL
Janssen Presents Updated Data at EHA for Teclistamab in Patients with Relapsed or Refractory Multiple Myeloma
Data show a combination of teclistamab (BCMAxCD3 bispecific antibody) plus DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) improved clinical efficacy in heavily pretreated patients with relapsed or refractory multiple myeloma
New IMBRUVICA® (ibrutinib) Data in Fixed-Duration Combination Regimen Presented at EHA 2022 Shows Deep, Durable Response at Three Years in Untreated Chronic Lymphocytic Leukemia
The all-oral, once-daily combination regimen also demonstrates the potential of immune restoration in this patient population
Janssen Presents Updated Results Evaluating First-in-Class GPRC5D Bispecific Antibody Talquetamab in Heavily Pretreated Patients with Multiple Myeloma
Updated results for talquetamab monotherapy and in combination with daratumumab highlighted in oral presentations at the 2022 EHA Annual Congress
Janssen Presents Initial Results from the Phase 2 RAGNAR Study of BALVERSA® (erdafitinib) in Patients with Advanced Solid Tumors with FGFR Alterations
Data from RAGNAR, the largest tumor-agnostic study reported for a targeted therapy and the first to evaluate FGFR-driven malignancies, featured in oral presentation at the 2022 ASCO Annual Meeting
Updated Data for Janssen’s Bispecific Teclistamab Suggest Continued Deep and Durable Responses in the Treatment of Patients with Relapsed or Refractory Multiple Myeloma
New teclistamab data presented at the 2022 ASCO Annual Meeting report longer follow-up from Phase 1/2 MajesTEC-1 study evaluating the BCMAxCD3 bispecific antibody, including progression-free survival and subgroup analyses Data from MajesTEC-1 study published in The New England Journal of Medicine
Longer-term Data from CARTITUDE-1 Study Demonstrate Continued Deep and Durable Responses to CARVYKTI™ (ciltacabtagene autoleucel) in Heavily Pretreated Patients with Relapsed or Refractory Multiple Myeloma
At nearly 28 months of median follow-up, median progression-free survival and overall survival were not yet reached Data presented at the 2022 ASCO Annual Meeting and published in the Journal of Clinical Oncology
Phase 3 SHINE Results Show IMBRUVICA® (ibrutinib)-Based Combination Regimen Significantly Reduced the Risk of Disease Progression or Death in Older Patients with Newly Diagnosed Mantle Cell Lymphoma
Primary results from the first frontline Phase 3 study of a Bruton’s tyrosine kinase inhibitor in MCL to be presented as late-breaking data at the 2022 ASCO Annual Meeting and also published in The New England Journal of Medicine
New Data Show Patients Treated with First-in-Class TREMFYA® (guselkumab) Achieve Durable Efficacy Across Joint and Axial Symptoms of Active Psoriatic Arthritis Through Two Years
Adult patients with active psoriatic arthritis experienced persistent multi-domain efficacy and a safety profile consistent with that seen in plaque psoriasis Further analyses show TREMFYA provided sustained improvements across measures of health-related quality of life