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Innovative Medicine
Johnson & Johnson ushers in the next wave of innovation in cancer care with more than 20 clinical and real-world studies at ASCO 2026
· Late-breaking Phase 3 PROTEUS data for ERLEADA® (apalutamide) selected to open the ASCO plenary, signaling a potential paradigm shift for high-risk prostate cancer in patients receiving curative-intent surgical treatment · Results from MajesTEC-9, the second positive Phase 3 study of TECVAYLI® (teclistamab-cqyv), reinforce TECVAYLI® regimens as potential new standard of care in multiple myeloma as early as second line · Pivotal OrigAMI-4 results evaluating RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) reinforce its potential to redefine treatment in advanced head and neck cancer
FDA grants Priority Review for IMAAVY® (nipocalimab-aahu) as the potential first approved treatment for people living with warm autoimmune hemolytic anemia (wAIHA)
Priority Review is granted to medicines that may offer significant improvements in safety or effectiveness for serious conditions like warm autoimmune hemolytic anemia, a life-threatening disease in which pathogenic immunoglobulin G autoantibodies attach to and destroy red blood cells, leading to debilitating anemia IMAAVY is designed to target the underlying cause of warm autoimmune hemolytic anemia by reducing circulating immunoglobulin G, including autoantibodies, while preserving critical immune functions Pivotal study showed rapid and durable hemoglobin responsea and fatigue improvementb compared to placebo in patients with warm autoimmune hemolytic anemia
FDA approves CAPLYTA® (lumateperone) sNDA with robust new data supporting reduced risk of relapse in schizophrenia
CAPLYTA® reduced relapse risk by 63 percent, with 84 percent of patients with schizophrenia relapse-free over six months Demonstrating long-term stability and a well-established safety profile consistent with previous CAPLYTA® studies
IMAAVY® (nipocalimab-aahu) shows over two years of sustained disease control in a broad population with generalized myasthenia gravis (gMG)
Through 120 weeks of follow-up, IMAAVY delivered sustained clinical improvements and reductions in total IgG in antibody-positive adult patients including anti-AChR+ and anti-MuSK+ Patients achieving sustained minimal symptom expression (MSE) experienced greater improvements in quality of life than those with transient MSE in a post-hoc analysis of the Phase 3 study EPIC, the first head-to-head study of IMAAVY versus another FcRn blocker in generalized myasthenia gravis, is now enrolling participants
INLEXZO™ (gemcitabine intravesical system) Assigned Permanent Billing Code, Supporting Access for Patients with Certain Bladder Cancers
· INLEXZO permanent J-code (J9183) effective April 1
ICOTYDE™ (icotrokinra) one-year results confirm lasting skin clearance and favorable safety profile in once‑daily pill for plaque psoriasis
Johnson & Johnson presents new data showing high rates of complete skin clearance achieved at Week 24 and Week 52 in ICONIC-ADVANCE 1 and 2 studies Nearly 60% of adolescents treated with ICOTYDE achieved completely clear skin at Week 52 in the ICONIC-LEAD study
FDA approval of ICOTYDE™ (icotrokinra) ushers in new era for first-line systemic treatment of plaque psoriasis with a targeted oral peptide
Johnson & Johnson introduces the first and only IL-23R targeted oral peptide that delivers complete skin clearance and favorable safety profile in a once-daily pill ICOTYDE offers an innovative new option for patients with moderate-to-severe plaque psoriasis to address patients cycling on topical therapies in need of systemic treatment
Johnson & Johnson highlights promising first-in-human Erda-iDRS (formerly TAR-210) results in intermediate‑risk non–muscle-invasive bladder cancer
· Data presented at EAU 2026 show an 89 percent complete response rate in intermediate‑risk disease with durable responses observed over 18 months and tolerable safety profile · Erda-iDRS has the potential to be the first targeted treatment for early‑stage bladder cancer
TECVAYLI®▼ (teclistamab) monotherapy application submitted to the EMA for relapsed/refractory multiple myeloma after at least one prior therapy
Application supported by Phase 3 data reinforcing teclistamab regimens as a potential standard of care after at least one prior therapy1 Teclistamab monotherapy delivered superior progression-free survival and overall survival versus standard of care, reducing the risk of disease progression or death by 71% in a high unmet need patient population2