Johnson & Johnson Innovative Medicine
Pharmaceutical Companies of Johnson and Johnson
Janssen Receives Positive CHMP Opinion for CARVYKTI (ciltacabtagene autoleucel; cilta-cel) for Treatment in Earlier Lines of Relapsed and Refractory Multiple Myeloma
Results from the phase 3 CARTITUDE-4 study, which supported the CHMP recommendation, showed that cilta-cel has the potential to offer significant benefit to patients in earlier lines of treatment Most patients with multiple myeloma relapse after current standard treatments and remain in need of additional therapeutic options at earlier stages of the disease. 23 February...
Janssen Submits Type II Extension of Indication Application to the European Medicines Agency Seeking Approval of RYBREVANT (amivantamab), in combination with Lazertinib, 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, showing statistically significant and clinically meaningful improvement in progression-free survival in patients with EGFR-mutated advanced NSCLC treated with amivantamab plus lazertinib versus osimertinib. Amivantamab is a fully-human EGFR-MET bispecific antibody with immune cell-directing activity that targets tumours with activating and resistance EGFR mutations...
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 CongressLazertinib is a highly selective, central nervous system-penetrant, third-generation EGFR tyrosine kinase inhibitor 21 December 2023 -- Beerse, Belgium -- The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the...
DARZALEX (daratumumab) Subcutaneous Formulation-based Quadruplet Therapy Regimen Shows Significant Improvement in Outcomes for Patients with Transplant-eligible Newly Diagnosed Multiple Myeloma
Daratumumab subcutaneous-based induction, consolidation and maintenance regimen reduced risk of progression or death by 58 percent compared to standard of care regimenFirst presentation of data from Phase 3 PERSEUS study highlighted in late-breaking abstract session at 2023 ASH Annual Meeting and simultaneously published in The New England Journal of Medicine 12 December 2023 -- Beerse,...
New Data Presented at ASH from the Phase 3 GLOW Study Show Fixed-Duration, First-Line Treatment with IMBRUVICA (ibrutinib) Plus Venetoclax Demonstrated an Overall Survival Rate of More Than 84% at 54 Months in Patients with Chronic Lymphocytic Leukaemia
Additional data from the phase 2 CAPTIVATE study, show 82% of patients with previously untreated chronic lymphocytic leukaemia (CLL) treated with fixed-duration ibrutinib plus venetoclax did not need next-line treatment at 54 months. 11 December 2023 -- Beerse, Belgium -- The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new long-term follow-up data at...
Janssen Submits Application to the European Medicines Agency forRYBREVANT▼ (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 Oncology 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...
Landmark Phase 3 MARIPOSA Study Shows RYBREVANT▼(amivantamab) Plus Lazertinib Resulted in 30% Reduction in Risk of Disease Progression or Death Compared to Osimertinib in Patients with EGFR-Mutated NSCLC
Early data show an overall survival trend favoring the combination of amivantamab and lazertinib compared to osimertinib; consistent results seen in patients with and without brain metastases Late-breaking results from the MARIPOSA study featured in a Presidential Symposium at 2023 ESMO Congress 23 October 2023 -- Beerse, Belgium -- The Janssen Pharmaceutical Companies of Johnson...
Results from Phase 2 THOR-2 Study Showed Improved Rates of Recurrence-Free Survival in Patients with High-Risk Non-Muscle-Invasive Bladder Cancer with Select Fibroblast Growth Factor Receptor Alterations Treated with Erdafitinib Versus Chemotherapy
Data from Cohort 1 of the phase 2 THOR-2 study showed oral erdafitinib reduced the risk of disease recurrence or death compared with intravesical standard-of-care chemotherapy 21 October 2023 -- Beerse, Belgium -- The Janssen Pharmaceutical Companies of Johnson & Johnson today announced results from Cohort 1 of the phase 2 randomised, open-label THOR-2 study...
New Safety Data Suggests SPRAVATO▼ (Esketamine Nasal Spray) is More Tolerable and Effective Compared to Quetiapine Extended-Release (XR) in Adults with Treatment-resistant Major Depressive Disorder
• The new safety data is from the ESCAPE-TRD Phase 3b study• Additional findings from this study showed esketamine NS demonstrated a significant increase in the proportion of patients achieving remission and response compared to quetiapine XR, based on the patient-reported Patient Health Questionnaire (PHQ-9) 8 October 2023 -- Beerse, Belgium -- The Janssen Pharmaceutical...
Janssen Submits MA Application to the European MedicinesAgency Seeking Approval of Erdafitinib for the Treatment of Patients with LocallyAdvanced or Metastatic Urothelial Cancer with Susceptible FGFR Alterations
Pending approval, erdafitinib, an investigational, once-daily oral pan-fibroblast growth factorreceptor (FGFR) tyrosine kinase inhibitor, will become the first therapy targeting FGFRalterations in patients with metastatic urothelial carcinoma, one of Europe’s most commoncancers. The submission is based on results from the phase 3 THOR study, which were featured in aLate-Breaking Presentation Session at the 2023 ASCO...
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