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September 27, 2023

Janssen Demonstrates Commitment to Transform the Treatment of Multiple Myeloma through Innovative Science and Industry-Leading Portfolio with Largest-Ever Presence at 20th International Myeloma Society Annual Meeting

Presentations to highlight latest data across biologic, bispecific and CAR-T therapies with added insights from Global Multiple Myeloma Call-to-Action

Innovative Medicine

September 6, 2023

Janssen Announces Update to Phase 3 MACiTEPH Study Evaluating Macitentan 75mg in Patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH)

Innovative Medicine

September 6, 2023

Phase 3 MARIPOSA-2 Study Meets Dual Primary Endpoint Resulting in Statistically Significant and Clinically Meaningful Improvement in Progression-Free Survival for RYBREVANT® (amivantamab-vmjw) Plus Chemotherapy With and Without Lazertinib versus Chemotherapy Alone in Patients with EGFR-Mutated Non-Small Cell Lung Cancer after Disease Progression on Osimertinib

MARIPOSA-2 is the first Phase 3 study to show statistically significant and clinically meaningful improvement in progression-free survival (PFS) in the post-osimertinib setting MARIPOSA-2 is the second RYBREVANT® Phase 3 study to show the potential to improve outcomes in patients with EGFR-mutated non-small cell lung cancer (NSCLC)

Innovative Medicine

August 28, 2023

Janssen Submits Supplemental New Drug Application to the U.S. Food and Drug Administration Seeking Full Approval of BALVERSA® (erdafitinib) for the Treatment of Patients with Locally Advanced or Metastatic Urothelial Carcinoma and Selected Fibroblast Growth Factor Receptor Gene Alterations

Submission Based on Confirmatory Data from Cohort 1 of the Phase 3 THOR Study, Which Showed a 36 Percent Reduction in the Risk of Death in Patients Treated with BALVERSA® Versus Chemotherapy

Innovative Medicine

August 25, 2023

Janssen Submits Supplemental Biologics License Application to the U.S. Food and Drug Administration Seeking Approval of RYBREVANT® (amivantamab-vmjw) in Combination with Chemotherapy for the First-line Treatment of Patients with Locally Advanced or Metastatic EGFR Exon 20 Insertion Mutation-Positive Non-Small Cell Lung Cancer

Application is supported by data from PAPILLON, the first randomized Phase 3 study to show clinically meaningful results in patients with NSCLC with EGFR exon 20 insertion mutations

Innovative Medicine

August 22, 2023

European Commission Approves TALVEY®▼ (talquetamab), Janssen’s Novel Bispecific Therapy for the Treatment of Patients with Relapsed and Refractory Multiple Myeloma

Talquetamab, the first bispecific antibody targeting GPRC5D, showed an overall response rate of more than 70 percent with durable responses, including responses achieved by over 60 percent of patients with prior T-cell redirection therapy.1,2

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Press releases

Janssen Demonstrates Commitment to Transform the Treatment of Multiple Myeloma through Innovative Science and Industry-Leading Portfolio with Largest-Ever Presence at 20th International Myeloma Society Annual Meeting

Janssen Announces Update to Phase 3 MACiTEPH Study Evaluating Macitentan 75mg in Patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH)

Janssen Submits Supplemental New Drug Application to the U.S. Food and Drug Administration Seeking Full Approval of BALVERSA® (erdafitinib) for the Treatment of Patients with Locally Advanced or Metastatic Urothelial Carcinoma and Selected Fibroblast Growth Factor Receptor Gene Alterations

European Commission Approves TALVEY®▼ (talquetamab), Janssen’s Novel Bispecific Therapy for the Treatment of Patients with Relapsed and Refractory Multiple Myeloma

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Press releases

Janssen Demonstrates Commitment to Transform the Treatment of Multiple Myeloma through Innovative Science and Industry-Leading Portfolio with Largest-Ever Presence at 20th International Myeloma Society Annual Meeting

Janssen Announces Update to Phase 3 MACiTEPH Study Evaluating Macitentan 75mg in Patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH)

Janssen Submits Supplemental New Drug Application to the U.S. Food and Drug Administration Seeking Full Approval of BALVERSA® (erdafitinib) for the Treatment of Patients with Locally Advanced or Metastatic Urothelial Carcinoma and Selected Fibroblast Growth Factor Receptor Gene Alterations

European Commission Approves TALVEY®▼ (talquetamab), Janssen’s Novel Bispecific Therapy for the Treatment of Patients with Relapsed and Refractory Multiple Myeloma

You are now leaving jnj.com/innovativemedicine