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December 21, 2023

Janssen Submits Marketing Authorisation Application to the European Medicines Agency Seeking Approval of Lazertinib, in combination with RYBREVANT®▼ (amivantamab), for the First-Line Treatment of Patients with EGFR-Mutated Non-Small Cell Lung Cancer

The submission is supported by data from the Phase 3 MARIPOSA study, which featured in a Late-Breaking Presidential Symposium session at the 2023 ESMO Congress1 Lazertinib is a highly selective, central nervous system-penetrant, third-generation EGFR tyrosine kinase inhibitor2,3

Innovative Medicine

December 21, 2023

Johnson & Johnson Submits Supplemental Biologics License Application and New Drug Application to U.S. FDA Seeking Approval of RYBREVANT® (amivantamab-vmjw) Plus Lazertinib for the Treatment of Patients with EGFR-Mutated Non-Small Cell Lung Cancer (NSCLC)

Submissions supported by data from landmark Phase 3 MARIPOSA study, which showed statistically significant and clinically meaningful improvement in progression-free survival in patients with EGFR-mutated advanced NSCLC treated with RYBREVANT® plus lazertinib versus osimertinib

Innovative Medicine

December 12, 2023

DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj)-based quadruplet therapy regimen shows significant improvement in outcomes for patients with transplant-eligible newly diagnosed multiple myeloma

DARZALEX FASPRO®-based induction, consolidation and maintenance regimen reduced risk of progression or death by 58 percent compared to standard of care regimen First presentation of data from Phase 3 PERSEUS study highlighted in late-breaking abstract session at ASH 2023 and simultaneously published in The New England Journal of Medicine

Innovative Medicine

December 11, 2023

New Analyses Demonstrate Versatility and Continued Efficacy of TALVEY™ in the Treatment of Patients with Relapsed or Refractory Multiple Myeloma

Analysis from MonumenTAL-1 study showed patients with relapsed or refractory multiple myeloma treated with TALVEY™ were subsequently treated effectively with several classes of therapy, including CAR-T Additional presentations at the 2023 ASH Annual Meeting showed potential improvement in adverse events among patients who received reduced intensity dosing and first-ever results from TALVEY™ combination study

Innovative Medicine

December 11, 2023

Treatment with CARVYKTI® (ciltacabtagene autoleucel) Resulted in Clinically Meaningful Improvements in Health-Related Quality of Life and Reductions in Disease-Specific Symptoms in Patients with Earlier-Line Multiple Myeloma

Oral presentations at the 2023 ASH Annual Meeting include patient-reported outcomes from the CARTITUDE-4 study and longer-term efficacy and safety data from CARTITUDE-2 study cohorts A and B, show the promise of CARVYKTI® in earlier lines of treatment

Innovative Medicine

November 29, 2023

Johnson & Johnson highlights its preeminent leadership in hematology through differentiated blood cancer portfolio and pipeline with new clinical and real-world data at ASH

Data highlights strength of multi-target, multi-platform multiple myeloma portfolio and continued innovation in B-cell malignancies to transform patient outcomes

Innovative Medicine

November 27, 2023

Janssen Submits Application to the European Medicines Agency for RYBREVANT®▼ (amivantamab) in Combination with Chemotherapy for the Treatment of Adult Patients with Advanced EGFR-Mutated Non-Small Cell Lung Cancer After Failure of Prior Therapy

The submission is supported by data from the Phase 3 MARIPOSA-2 study featured in a Late-Breaking Presidential Symposium session at the 2023 ESMO Congress and simultaneously published in Annals of Oncology1,2 Amivantamab plus chemotherapy demonstrated significant improvements in progression-free survival, compared to chemotherapy alone, in patients with EGFR-mutated advanced non-small cell lung cancer following prior osimertinib therapy1

Innovative Medicine

November 20, 2023

Janssen Submits Supplemental Biologics License Application to U.S. FDA Seeking Approval of RYBREVANT® (amivantamab-vmjw) Plus Chemotherapy for the Treatment of Patients with EGFR-Mutated Non-Small Cell Lung Cancer Who Progressed on or after Osimertinib

This submission is supported by data from the Phase 3 MARIPOSA-2 Study featured in a Late-Breaking Presidential Symposium session at the 2023 ESMO Congress and simultaneously published in Annals of Oncology RYBREVANT® plus chemotherapy showed significant improvement in primary endpoint of progression-free survival, compared to chemotherapy alone, in patients with EGFR-mutated advanced non-small cell lung cancer following prior osimertinib therapy

Innovative Medicine

November 8, 2023

New Real-World Data Show TREMFYA® (guselkumab) Was Associated With Clinically Meaningful Improvements in Patient-Reported Outcomes for Adults Living With Active Psoriatic Arthritis

People living with treatment-resistant active psoriatic arthritis reported meaningful improvements in pain, physical function and fatigue on TREMFYA through six monthsAdditional pooled data from three clinical trials support the established efficacy of TREMFYA in key psoriatic domains across those who were bio-naïve or TNFi-experienced

Innovative Medicine

November 7, 2023

Phase 2 Nipocalimab Data Establish Proof of Mechanism in Adults Living with Moderate to Severe Rheumatoid Arthritis, Supporting its Progression into a Combination Study

This first-ever clinical study of an FcRn inhibitor in RA showed nipocalimab reduced levels of circulating IgG antibodies, including ACPAs, indicating they may play a key role in driving RA disease activity. Nipocalimab demonstrated improvements in primary and secondary endpoints and participants with higher baseline ACPAs had more than twice the placebo adjusted DAS28-CRP remission compared to the overall study population

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