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New Data from Phase 3 PAPILLON Study Show RYBREVANT® (amivantamab-vmjw) Plus Chemotherapy Resulted in 60% Reduction in Risk of Disease Progression or Death in Patients with Previously Untreated EGFR Exon 20 Insertion Mutation-Positive NSCLC
Oct 21, 2023 Spain New Data from Phase 3 PAPILLON Study Show RYBREVANT ® (amivantamab-vmjw) Plus Chemotherapy Resulted in 60 Percent Reduction in Risk of Disease Progression or Death in Patients with Previously Untreated EGFR Exon 20 Insertion Mutation ...
Landmark Phase 3 MARIPOSA Study Shows RYBREVANT® (amivantamab-vmjw) Plus Lazertinib Resulted in 30 Percent Reduction in Risk of Disease Progression or Death Compared to Osimertinib in Patients with EGFR-Mutated Non-Small Cell Lung Cancer
Oct 23, 2023 Spain Early data show an overall survival trend favoring the combination of RYBREVANT ® and lazertinib compared to osimertinib; consistent results seen in patients with and without brain metastases Late-breaking results from the MARIPOSA ...
RYBREVANT® (amivantamab-vmjw) plus lazertinib is the only chemotherapy-free regimen showing longer progression-free survival versus osimertinib in first-line treatment of patients with high-risk EGFR-mutated non-small cell lung cancer
May 31, 2024 Investigational chemotherapy-free regimen of RYBREVANT® plus lazertinib addresses a significant unmet need as most patients with EGFR-mutated NSCLC have high-risk disease Landmark Phase 3 MARIPOSA data featured in an oral presentation at ASCO ...
Subcutaneous amivantamab Biologics License Application submitted to U.S. FDA for patients with EGFR-mutated non-small cell lung cancer
Jun 17, 2024 Application based on Phase 3 PALOMA-3 results showing five-fold reduction in infusion-related reactions with five-minute administration of subcutaneous amivantamab Longer overall survival, progression-free survival and duration of response ...
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 Chemother
Sep 06, 2023 United States 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 ...
Janssen Announces Positive Topline Results for JNJ-2113—a Novel, First and Only Oral IL-23 Receptor Antagonist Peptide in Development for Moderate-to-Severe Plaque Psoriasis
Jul 04, 2023 United States A greater proportion of patients achieved 100 percent improvement in skin clearance at the highest dose level tested compared to placebo, at week 16 Phase 3 clinical development in moderate-to-severe plaque psoriasis is planned ...
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 Metast
Aug 25, 2023 United States 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 RARITAN, New Jersey, August 25, 2023 – The ...
RYBREVANT® (amivantamab-vmjw) plus standard of care approved in the U.S. as first and only targeted regimen to cut risk of disease progression by more than half in second-line EGFR-mutated advanced lung cancer
Sep 19, 2024 United States Approval based on compelling safety and efficacy from the Phase 3 MARIPOSA-2 study, marking the third new indication for RYBREVANT ® this year, with four indications overall RARITAN, New Jersey (September 19, 2024) – Johnson ...
RYBREVANT® (amivantamab-vmjw) in Combination With Chemotherapy Is the First FDA Approved Therapy for First-line Treatment of Patients With Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations
Mar 01, 2024 United States Approval is based on results from the Phase 3 PAPILLON study, which demonstrated RYBREVANT ® plus chemotherapy reduced the risk of disease progression or death by 61 percent versus chemotherapy alone in patients with previously ...
European Commission Approves TALVEY®▼ (talquetamab), Janssen’s Novel Bispecific Therapy for the Treatment of Patients with Relapsed and Refractory Multiple Myeloma
Aug 22, 2023 Belgium 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 ...