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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 ...
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 ...
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 ...
Late-breaking results from PALOMA-2 study of subcutaneous amivantamab in combination with lazertinib show clinically meaningful antitumor response and improved safety profile in patients with EGFR-mutated non-small cell lung cancer
Jun 03, 2024 Significantly lower infusion-related reactions seen with subcutaneous amivantamab compared with intravenous administration in new Phase 2 data CHICAGO (June 3, 2024) – Johnson & Johnson announced today new data from the Phase 2 PALOMA-2 ...
New Long-Term Data from the CHRYSALIS Study Show Median PFS Not Reached after 33.6 Months of Follow Up with First-Line Use of RYBREVANT® (amivantamab-vmjw) and Lazertinib Combination Therapy in Patients with Treatment-Naïve EGFR-Mutated Advanced NSCLC
Jun 04, 2023 United States Further analyses from the Phase 1/1b CHRYSALIS-2 study showed patients with osimertinib pre-treated EGFR-mutated lung cancer who have a MET positive biomarker had an overall response rate of 61 percent and a median PFS of 12.2 ...
First results from late-breaking Phase 3 PALOMA-3 study show five-fold reduction in infusion-related reactions with five-minute subcutaneous amivantamab administration
May 31, 2024 New formulation showed non-inferiority to intravenous administration in fourth positive Phase 3 study in RYBREVANT® clinical program Longer overall survival, progression-free survival and duration of response shown with subcutaneous ...
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 ...
New RYBREVANT® (amivantamab-vmjw) Data Showed Long-Term Clinical Response and Safety in Patients with Advanced Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations Who Have Failed Prior Platinum-Based Chemotherapy
Mar 29, 2023 Denmark COPENHAGEN, DENMARK, March 29, 2023 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new long-term data from the CHRYSALIS study evaluating RYBREVANT ® (amivantamab-vmjw) in patients with advanced non ...
Treatment with RYBREVANT® (amivantamab-vmjw) Plus Chemotherapy Resulted in Statistically Significant and Clinically Meaningful Improvement in Progression-Free Survival in Patients with Newly Diagnosed EGFR Exon 20 Insertion Mutation-Positive Non-Small Cel
Jul 17, 2023 United States First Phase 3 study to demonstrate clinically meaningful results versus standard of care in a newly diagnosed exon 20 population, a patient population with high unmet medical need RARITAN, New Jersey, July 17, 2023 – The ...
Landmark Phase 3 MARIPOSA Study Meets Primary Endpoint Resulting in Statistically Significant and Clinically Meaningful Improvement in PFS for RYBREVANT® (amivantamab-vmjw) plus Lazertinib Versus Osimertinib in Patients with EGFR-Mutated NSCLC
Sep 28, 2023 United States Planned interim overall survival analysis showed a trend favoring the combination of RYBREVANT ® and lazertinib compared to osimertinib* First pivotal study to show a clinically meaningful benefit in a chemotherapy-free regimen ...