SILVER SPRING, Md., Aug. 20, 2024 /PRNewswire/ -- Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:
CHICAGO, June 3, 2024 /PRNewswire/ -- Johnson & Johnson announced today new data from the Phase 2 PALOMA-2 study evaluating subcutaneous (SC) amivantamab combined with lazertinib as a first-line treatment in patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion (ex19del) or L858R mutations. These data, which were featured in a late-breaking poster presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract #LBA8612), showed a comparable response rate in patients treated with SC amivantamab and lazertinib compared to those treated with the intravenous (IV) formulation in the MARIPOSA study, which established the combination of amivantamab and lazertinib as superior to osimertinib. SC amivantamab was associated with significantly lower rates of infusion-related reactions (IRRs) and shorter treatment time compared with the IV formulation.1
Significantly lower infusion-related reactions seen with subcutaneous amivantamab compared with intravenous administration in new Phase 2 data1 BEERSE, BELGIUM, June 03, 2024 (GLOBE...
CHICAGO, May 31, 2024 /PRNewswire/ -- Johnson & Johnson announced today first data from the Phase 3 PALOMA-3 study evaluating subcutaneous (SC) amivantamab combined with lazertinib in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion (ex19del) or L858R mutations. Study results showed non-inferior efficacy and pharmacokinetics for SC amivantamab combined with lazertinib compared to intravenous (IV) administration, the currently approved formulation of RYBREVANT® (amivantamab-vmjw). Administration time for SC amivantamab was reduced to approximately five minutes from five hours (across two days) and showed a five-fold reduction in infusion-related reactions (IRRs). These late-breaking results, which are the Company's fourth positive Phase 3 readout for the RYBREVANT® clinical program, were featured as an oral presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract #LBA8505).1 Data were also selected for the Best of ASCO 2024 Meetings, highlighting the cutting-edge science and leading research in oncology from Johnson & Johnson.
CHICAGO, May 31, 2024 /PRNewswire/ -- Johnson & Johnson today announced new data from the Phase 3 MARIPOSA study demonstrating the benefit of first-line treatment with RYBREVANT® (amivantamab-vmjw) in combination with lazertinib in patients with high-risk disease or clinical features, which occur in nearly 85 percent of patients with non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations. Results from the new analysis show the RYBREVANT® combination consistently and significantly improved progression-free survival (PFS) compared to osimertinib in patients with NSCLC with EGFR exon 19 deletion (ex19del) or L858R mutations. These data were presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract #8504).1
RARITAN, N.J., Dec. 21, 2023 /PRNewswire/ -- Johnson & Johnson announced today the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) together with a New Drug Application (NDA) seeking the approval of RYBREVANT® (amivantamab-vmjw) in combination with lazertinib for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or L858R substitution mutations, as detected by an FDA-approved test. Based on the Phase 3 MARIPOSA study, this marks the third submission from the RYBREVANT® clinical development program in four months, following sBLA submissions for MARIPOSA-2 and PAPILLON.
J&J details Tagrisso-topping data for Rybrevant, Leclaza combo
MADRID, Oct. 23, 2023 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson today announced results from the Phase 3 MARIPOSA study showing RYBREVANT® (amivantamab-vmjw) in combination with lazertinib compared to osimertinib resulted in a 30 percent reduction in the risk of disease progression or death (Hazard Ratio [HR]=0.70; 95 percent Confidence Interval [CI], 0.58–0.85; p value P<0.001) in the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with either epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or L858R substitution Results also showed a favorable trend in overall survival (OS) for RYBREVANT® and lazertinib in these patients compared to osimertinib (HR=0.80; 95 percent CI, 0.61–1.05; P=0.11) at a first interim analysis. These data were presented in a Presidential Symposium at the European Society for Medical Oncology (ESMO) 2023 Congress taking place October 20-24, 2023 in Madrid, Spain (Abstract #LBA14).1
Johnson & Johnson said that its combination treatment staved off cancer progression for longer than AstraZeneca’s blockbuster Tagrisso as a first option for patients with a form of advanced lung cancer.
SINGAPORE, Sept. 11, 2023 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson today announced follow-up results from the Phase 1b/2 CHRYSALIS-2 study cohort evaluating the safety and tolerability of the combination of RYBREVANT® (amivantamab-vmjw), a bispecific antibody targeting epidermal growth factor receptor (EGFR) and mesenchymal-epithelial transition (MET), with lazertinib, an oral third-generation EGFR tyrosine kinase inhibitor (TKI), plus platinum-based chemotherapy (carboplatin and pemetrexed) in patients with relapsed/refractory non-small cell lung cancer (NSCLC) and EGFR mutations. These findings are being presented at the International Association for the Study of Lung Cancer (IASLC) 2023 World Congress on Lung Cancer (WCLC) from September 9-12 in Singapore.1