Innovative Medicine
-
Johnson & Johnson announces U.S. FDA Approval of RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) as First and Only Dual-Targeted Therapy for Advanced Head and Neck Cancer
· Accelerated approval based on data demonstrating clinically meaningful efficacy, including a 42 percent overall response rate (95 percent confidence interval, 32–52 percent)1 · First advancement in the second-line treatment setting for recurrent or metastatic head and neck cancer in a decade, bringing a new subcutaneous option to patients with significant unmet need 2-3 · Extending its well-established, dual-targeted benefit beyond lung cancer, RYBREVANT FASPRO™ targets both EGFR and MET pathways – two key drivers of tumor progression in head and neck cancer 2 -
RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) combination demonstrates 77% overall response rate in first-line treatment of patients with advanced head and neck cancer
Responses were deep and durable, with 65% ongoing at clinical cutoff Results support continued evaluation of the investigational RYBREVANT FASPRO regimen in the ongoing first-line Phase 3 study Data highlight the role of dual-targeting EGFR and MET, key drivers of tumor growth and resistance seen in 80 to 90 percent of HNSCC -
Johnson & Johnson announces ERLEADA® (apalutamide) treatment before and after surgery reduces risk of recurrence or death by 62% versus surgery alone in high-risk prostate cancer
· New substudy results showed a 51% lower estimated risk of metastasis or death over time with perioperative apalutamide plus ADT compared with immediate surgery · Twice as many patients remained free from subsequent treatment at three years with perioperative apalutamide plus ADT compared with surgery alone · Results evaluated outcomes versus surgery alone, building on the primary results presented at ASCO 2026 -
Johnson & Johnson advances the next generation of solid tumor therapies with new data at ESMO 2026
· First readout following acquisition of the RIPTAC™ platform shows promising anti-tumor activity with JNJ-6143, a novel oral investigational molecule, in difficult-to-treat prostate cancer · New first-line head and neck cancer data highlight the potential of RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) and its dual EGFR-MET approach, building on the established role of RYBREVANT®-based regimens in lung cancer · New ERLEADA® (apalutamide) substudy findings in prostate cancer build on the primary results presented at ASCO 2026 -
Johnson & Johnson showcases breadth of rheumatology innovation at ACR Convergence 2026 with 43 presentations, including late-breaking data on ICOTYDE® (icotrokinra) in psoriatic arthritis
Patient data from the Phase 2 study of nipocalimab in Sjögren’s disease identify improvements in most core patient-relevant symptoms, with associated improvements in health-related quality of life Positive Phase 2 data support continued development of nipocalimab in systemic lupus erythematosus; Phase 3 study is recruiting -
Johnson & Johnson announces new data showing TREMFYA® (guselkumab) is the only IL-23 to deliver durable fistula remission through 48 weeks in Crohn’s disease with perianal fistula
· TREMFYA maintained combined fistula remission through Week 48 across both maintenance dose regimens, including an increase from 28% at Week 24 to 35% at Week 48 in the 100 mg dose group · These findings build on the Phase 3 clinical program, demonstrating efficacy in a dedicated, randomized, placebo-controlled trial in patients with this debilitating and challenging manifestation of Crohn’s disease -
New TREMFYA® (guselkumab) study shows consistent perianal fistula remission across key Crohn’s disease patient subgroups
· New prespecified analyses showed consistent findings across clinically important and difficult to treat subgroups, including patients with prior biologic exposure · Findings build on first positive results where TREMFYA achieved combined fistula remission rates of up to 28% across dosing groups · Results come from the first dedicated Phase 3 randomized, placebo-controlled trial in adults managing Crohn’s disease with perianal fistula in more than 20 years -
TREMFYA® (guselkumab) demonstrated sustained clinical and endoscopic remission through 3 years in moderately to severely active Crohn’s disease
· New long-term data showed clinical remission rates of up to 94% and endoscopic remission rates of up to 61% in adults with moderately to severely active Crohn’s disease · 88% of patients achieved 90-day corticosteroid-free clinical remission -
Johnson & Johnson announces TREMFYA® (guselkumab) is the first and only IL-23 inhibitor to show significant improvement in spinal pain and stiffness in landmark axial psoriatic arthritis (PsA) study
· Topline results show TREMFYA met the primary and major secondary endpoints of axial involvement in PsA - including spinal pain and stiffness - and demonstrated significant improvement in MRI-confirmed inflammation · First-ever study to use objective MRI assessments to confirm presence of axial involvement and demonstrate axial inflammation reduction in PsA