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European Commission Approves IMBRUVICA® (ibrutinib) in a Fixed-Duration Combination Regimen for Adult Patients with Previously Untreated Chronic Lymphocytic Leukaemia (CLL)
Approval marks the first all-oral, once-daily, fixed-duration Bruton’s tyrosine kinase (BTK) inhibitor-based regimen for first-line treatment of CLL
STELARA® (ustekinumab) Approved by the U.S. Food and Drug Administration to Treat Pediatric Patients with Active Psoriatic Arthritis
As the first and only biologic targeting both cytokines interleukin (IL)-12 and IL-23, STELARA provides a new therapeutic option for children six years of age and older living with active psoriatic arthritis Active psoriatic arthritis in pediatric patients is a rare disease affecting five to eight percent of children and adolescents with chronic inflammatory arthritis*1-6
Janssen Receives Positive CHMP Opinion for Novel Bispecific Antibody TECVAYLI® (teclistamab) for the Treatment of Patients with Relapsed and Refractory Multiple Myeloma (RRMM)
Teclistamab is the first T-cell redirecting bispecific antibody to receive a positive CHMP opinion for adults with RRMM and highlights Janssen’s commitment to innovation in multiple myeloma The opinion is based on the MajesTEC-1 study where teclistamab induced durable responses that deepened over time in patients with heavily pretreated RRMM[1]
Janssen Announces U.S. FDA Breakthrough Therapy Designation Granted for Talquetamab for the Treatment of Relapsed or Refractory Multiple Myeloma
Novel GPRC5DxCD3 Bispecific Antibody Receives Breakthrough Therapy Designation Based Upon Results from the Phase 1/2 MonumenTAL-1 Study
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