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Janssen Announces U.S. FDA Breakthrough Therapy Designation Granted for Teclistamab for the Treatment of Relapsed or Refractory Multiple Myeloma
U.S. Milestone Follows European Medicines Agency PRIME Designation for this BCMA Bispecific Antibody for the Treatment of Relapsed or Refractory Multiple Myeloma
Janssen Reports New Data for BCMA CAR-T, Cilta-Cel, Showing Deep and Durable Responses in Patients with Relapsed or Refractory Multiple Myeloma
Eighteen-month follow-up from pivotal CARTITUDE-1 study, including progression-free-survival data, to be presented at ASCO and EHA Annual Meetings Findings from the Phase 2 CARTITUDE-2 study will be presented for the first time
Updated Data Demonstrate Significant Improvement in Hematologic Complete Response with DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in Patients with Newly Diagnosed Light Chain (AL) Amyloidosis
Further analysis from the Phase 3 ANDROMEDA study presented at the 2021 ASCO Annual Meeting also show doubling rates of organ response with no new safety signals for the first FDA-approved treatment in a rare blood cell disorder
Janssen Presents Updated Data on First-in-Class Talquetamab at ASCO Suggesting Deep and Durable Responses in Heavily Pretreated Patients with Multiple Myeloma
Results from Phase 1 study of novel GPRC5DxCD3 T-cell redirecting bispecific antibody demonstrate promising clinical activity and support recommended Phase 2 dose
Janssen’s Updated Phase 1 Results for Teclistamab Suggest Deep, Durable Responses in Patients with Heavily Pretreated Multiple Myeloma
Subcutaneous administration of BCMAxCD3 T-cell redirecting bispecific antibody demonstrated clinical activity and a promising safety profile according to new data at ASCO
European Commission approves PONVORYTM (ponesimod), a Once Daily, Oral Therapy for the Treatment of Adults with Relapsing Forms of Multiple Sclerosis with Active Disease Defined by Clinical or Imaging Features
· The pivotal Phase 3 OPTIMUM trial showed treatment with ponesimod led to a 30.5 percent reduction in annual relapse rate (p<0.001) vs. treatment with teriflunomide, an active comparator and widely-used first-line oral treatment, in adult patients with relapsing multiple sclerosis, (RMS)1 · The OPTIMUM trial is the first of its kind to compare head-to-head two oral disease modifying treatments (DMTs) in RMS · Approval follows more than 10 years of cumulative data from Phase 2 and Phase 3 studies demonstrating ponesimod’s efficacy and safety1,2,3 · Approval builds on Janssen’s deep-rooted history in neuroscience and reinforces Company commitment to addressing unmet needs for neurological conditions like MS
Janssen Presents Results of First Head-to-Head Study of Biologic Therapies in Patients with Moderate to Severe Crohn’s Disease
Late-breaker is one of 20 Janssen abstracts, 16 of which show the safety profile and efficacy of STELARA in treating Crohn’s disease and ulcerative colitis at Digestive Disease Week (DDW) Virtual 2021
IMBRUVICA® (ibrutinib)-Based Combination Regimen as a Fixed-Duration, First-Line Treatment for Chronic Lymphocytic Leukemia Demonstrates High Rates of Disease Control
Janssen presents new data at ASCO showing efficacy of IMBRUVICA® plus venetoclax (CAPTIVATE study) in previously untreated patients with chronic lymphocytic leukemia, and up to seven-year follow-up results (RESONATE-2 study) on progression-free and overall survival benefits with single-agent IMBRUVICA®
Updated Amivantamab and Lazertinib Combination Data Demonstrate Durable Responses and Clinical Activity for Osimertinib-Relapsed Patients with EGFR-Mutated Non-Small Cell Lung Cancer
Findings to be presented at the ASCO Annual Meeting show preliminary efficacy in patients with EGFR-mutated NSCLC and Janssen’s commitment to address the need for new targeted therapies for this patient population Janssen to also present data comparing amivantamab monotherapy and real-world therapies in patients with NSCLC with EGFR exon 20 insertion mutations who have progressed after platinum doublet chemotherapy