Innovative Medicine
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Johnson & Johnson to Acquire Ambrx, Advancing Next Generation Antibody Drug Conjugates to Transform the Treatment of Cancer
Portfolio of Clinical and Preclinical Programs, Including Lead Product Candidate ARX517, a Prostate-Specific Membrane Antigen (PSMA)-Targeting Antibody Drug Conjugate (ADC), Strengthens Johnson & Johnson’s Commitment to Oncology Innovation Novel Technology Platform Sets Stage for the Development of Next Generation ADCs and Targeted Oncologic Therapeutics -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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