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June 26, 2023

Janssen Submits Marketing Authorisation Application to the European Medicines Agency (EMA) Seeking Approval of Single Tablet Combination Therapy (STCT) of Macitentan and Tadalafil for Treatment of Patients with Pulmonary Arterial Hypertension (PAH)

This is the first and only single tablet combination therapy to be submitted for review in Europe for this rare, progressive disease If approved, Janssen’s comprehensive PAH portfolio has the potential to cover all guideline-recommended treatment pathways

Innovative Medicine

June 6, 2023

Janssen Submits Supplemental Biologics License Application to U.S. FDA Seeking Approval of CARVYKTI® for the Earlier Treatment of Patients with Relapsed or Refractory Multiple Myeloma

Application is supported by data from the Phase 3 CARTITUDE-4 study, which showed significant improvement in primary endpoint of progression-free survival (PFS) CARTITUDE-4 is the first randomized Phase 3 study investigating the efficacy of a cell therapy as early as after first relapse in multiple myeloma

Innovative Medicine

June 5, 2023

Janssen Presents Longer-Term Data for TECVAYLI® (teclistamab-cqyv) Showing a Duration of Response of 22 Months in Patients with Relapsed or Refractory Multiple Myeloma

More than 60 percent of patients achieved an overall response and 45.5 percent of patients achieved a complete response or better by nearly five months Additional data highlights strong efficacy with biweekly TECVAYLI® dosing and show strategies for improving cytokine release syndrome with prophylactic tocilizumab

Innovative Medicine

June 5, 2023

CARVYKTI® (ciltacabtagene autoleucel) Reduces Risk of Disease Progression or Death by 74 Percent in Earlier-Line Multiple Myeloma Treatment in the Landmark Phase 3 CARTITUDE-4 Study

At 16-months median follow-up, CARVYKTI® significantly improved progression-free survival compared to two standard treatmentsi Data presented at the 2023 ASCO and EHA Annual Meetings and published in The New England Journal of Medicine

Innovative Medicine

June 5, 2023

Janssen Announces BALVERSA® (erdafitinib) Improved Overall Survival Versus Chemotherapy in Patients with Metastatic or Unresectable Urothelial Carcinoma and Selected Fibroblast Growth Factor Receptor Gene Alterations After Prior Anti-PD-(L)1 Treatment

Confirmatory Data from Cohort 1 of the Phase 3 THOR Study Showed Greater Than Four- Month Improvement in Median Overall Survival in Patients Treated with BALVERSA® Versus Chemotherapy

Innovative Medicine

June 4, 2023

New Long-Term Data from the CHRYSALIS Study Show Median Progression-Free Survival Not Reached after 33.6 Months of Follow-Up with First-Line Use of RYBREVANT® (amivantamab-vmjw) and Lazertinib Combination Therapy in Patients with Treatment-Naïve EGFR-Mutated Advanced Non-Small Cell Lung Cancer

Further analyses from the Phase 1/1b CHRYSALIS-2 study showed patients with osimertinib pre-treated EGFR-mutated lung cancer who have a MET positive biomarker had an overall response rate of 61 percent and a median PFS of 12.2 months when treated with the chemotherapy-free combination of RYBREVANT® and lazertinib Updated safety analysis from the Phase 1 PALOMA study evaluating subcutaneous delivery of RYBREVANT® showed shorter administration time and a marked reduction in the incidence and severity of infusion-related reactions

Innovative Medicine

June 3, 2023

Janssen Presents First-Ever Results from Dual Bispecific Combination Study Showing 96 Percent Overall Response Rate in Patients with Relapsed or Refractory Multiple Myeloma

Innovative Medicine

June 3, 2023

Janssen Presents Longer-Term Talquetamab Follow-Up Data Showing Overall Response Rates of More Than 70 Percent in Heavily Pretreated Patients with Multiple Myeloma

Additional long-term data from the TRiMM-2 study in patients receiving talquetamab and DARZALEX FASPRO® combination biweekly regimen showed an overall response rate of more than 80 percent

Innovative Medicine

May 31, 2023

TREMFYA® (guselkumab) Provides Sustained Improvements Across All Minimal Disease Activity Domains for Adults Living with Active Psoriatic Arthritis in Phase 3b Trial

Additional post-hoc clinical data will be presented from Phase 3 DISCOVER trials providing clinical insights on the importance of shared decision making to address patient-reported symptoms

Innovative Medicine

May 30, 2023

Janssen Submits New Drug Application to U.S. FDA Seeking Approval of Investigational Single Tablet Combination Therapy of Macitentan and Tadalafil for Treatment of Patients with Pulmonary Arterial Hypertension (PAH)

This is the first and only single tablet combination therapy application to be submitted for review in the U.S. for this rare, progressive disease If approved, Janssen’s comprehensive PAH portfolio has the potential to cover all guidelines-recommended treatment pathways

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