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Innovative Medicine
Early study results from Johnson & Johnson show promising antitumor activity with combination of pasritamig and docetaxel in advanced prostate cancer
Combination demonstrates deep PSA responses and favorable safety profile with plans to advance into Phase 3 Data highlight the potential of this first-in-class next-generation T-cell engager to expand the role of immunotherapy in prostate cancer
Johnson & Johnson seeks FDA approval of IMAAVY® (nipocalimab-aahu) as the first-ever FDA-approved treatment for warm autoimmune hemolytic anemia (wAIHA)
Data from the pivotal ENERGY trial showed IMAAVY® produced a rapid and durable hemoglobin responsea in wAIHA Currently no FDA-approved therapies are available for wAIHA, a rare, heterogeneous, life-threatening disease in which pathogenic immunoglobulin (IgG) autoantibodies attach to and destroy red blood cells, leading to debilitating anemia
Subcutaneous RYBREVANT®▼ (amivantamab) approved by European Commission for every-three-week and every-four-week dosing for patients with advanced EGFR-mutated non-small cell lung cancer
Subcutaneous (SC) amivantamab reduces administration from hours to minutes, with efficacy and safety consistent with intravenous (IV) amivantamab1,2,3,4,5 SC amivantamab is now authorised across all previously approved IV indications, offering fewer administration-related reactions and new dosing options1,2,3,4,5,6
TREMFYA® (guselkumab) long-term data show sustained clinical and endoscopic remission in ulcerative colitis through 3 years
More than 80% of those treated with TREMFYA® were in clinical remission and more than 50% were in endoscopic remission at Week 140 of the QUASAR long-term extension study, showing lasting disease control for patients 78% of patients achieved intestinal healing at both the tissue and visual level (histo-endoscopic mucosal improvement)
RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) plus immunotherapy shows strong clinical benefit with 56 percent overall response rate in first-line recurrent or metastatic head and neck cancer
Ten percent complete response and rapid, durable antitumor activity reported with RYBREVANT FASPRO™; results surpass current standards of care
RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) receives U.S. FDA Breakthrough Therapy Designation for patients with advanced head and neck cancer
New designation is based on data showing rapid and durable responses in a heavily pretreated patient population and expands the promise of RYBREVANT FASPRO™ beyond lung cancer
FDA approves RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) as the only EGFR-targeted therapy that can be administered once a month
Monthly dosing reduces treatment visits while maintaining established safety and efficacy1,2 Builds on RYBREVANT FASPRO™ FDA approval to deliver the simplest and fastest combination regimen for EGFR+ non-small cell lung cancer1,3-6
Real-world head-to-head analysis shows 51% reduction in risk of death for patients with metastatic castration-sensitive prostate cancer treated with ERLEADA® (apalutamide) versus darolutamide without docetaxel through 24 months
First ever head-to-head analysis compares overall survival outcomes of ERLEADA® versus darolutamide Retrospective study reinforces real-world efficacy of ERLEADA® for patients with mCSPC
Johnson & Johnson receives CHMP positive opinion for AKEEGA® (niraparib and abiraterone acetate dual action tablet) for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC) with BRCA1/2 mutations
AMPLITUDE is the first clinical trial to evaluate potential therapies for patients with mHSPC and known HRR gene alterations, with positive results supporting the niraparib-based combination regimen as a new standard of care for patients with BRCA mutations1 Results demonstrate a delay in disease progression and an early trend toward improved overall survival with the niraparib and abiraterone acetate regimen versus standard of care in the treatment of mHSPC1