Innovative Medicine

Updated results reinforce the potential of TAR-210 to transform treatment of non–muscle-invasive bladder cancer with fibroblast growth factor receptor (FGFR) alterations

Study highlights opportunity for treatment intensification in this population since approximately 50% of patients with high-risk localized prostate cancer (HRLPC) experience disease recurrence within two years of surgery

New data from Phase 2b SunRISe-1 study show rapid achievement of complete response (CR) with 98% achieving a CR within 12 weeks TAR-200 provides durable CRs in patients with Bacillus Calmette-Guérin (BCG)–unresponsive high-risk non–muscle-invasive bladder cancer (NMIBC) with carcinoma in situ – a disease area with limited treatment options for patients

Submission included data from the Phase 3 QUASAR program in ulcerative colitis and the Phase 3 GALAXI program in Crohn’s disease, which each achieved their primary endpoints1,2

CHMP recommends Conditional Marketing Authorisation be converted into standard Marketing Authorisation Recommendation supported by results from the Phase 3 STREAM Stage 2 study, which show bedaquiline-containing regimens offer significant improvement compared to other available therapies

This positive CHMP opinion establishes amivantamab as a new option, and the first fully-human EGFR-MET bispecific antibody, in the first-line treatment of EGFR exon 20 insertion-mutated NSCLC The recommendation is supported by data from the Phase 3 PAPILLON study, which showed amivantamab plus chemotherapy significantly improved progression-free survival in adult patients, versus chemotherapy alone1

Expanded indication for this one-time infusion may provide patients with a potential period away from their multiple myeloma treatment as early as first relapse1 Approval is based on results from the PHASE 3 CARTITUDE-4 study, in which treatment with cilta-cel in 1-3 prior lines of therapy reduced the risk of disease progression or death by 74 percent compared to standard therapies1

Analysis of clinical and non-clinical studies supports the investigational treatment’s potential for rapid, deep and sustained immunoglobulin G (IgG) lowering

New exploratory analysis demonstrates consistent results of XARELTO® in treating elderly and non-elderly patients with nonvalvular atrial fibrillation undergoing percutaneous coronary intervention XARELTO® is one of the most studied oral anticoagulants, and has been prescribed to more than 10 million patients in the United States