Innovative Medicine

If approved, daratumumab will be the only anti-CD38 available for all patient types across newly diagnosed multiple myeloma, cementing daratumumab as a foundational therapy in the frontline setting. Recommendation supported by results from CEPHEUS, the fifth Phase 3 study of daratumumab to demonstrate improved progression free survival in the frontline setting.1,2,3,4

Phase 3 ASTRO study achieves primary and all secondary endpoints at Week 12 in ulcerative colitis patients The only SC induction data for an IL-23 inhibitor show statistically significant and clinically meaningful improvements across clinical and endoscopic measures versus placebo, consistent with IV induction

Published results reinforce the high-affinity binding and immunoselective properties of nipocalimab, which has been shown to reduce IgG levels by >75%, including autoantibodies, potentially without affecting other immune functions

Independent, scheduled review finds investigational vaccine regimen lacks efficacy in preventing invasive E. coli disease (IED) No safety signals identified

Data from the Phase 3 PALOMA-3 study showed non-inferiority to intravenous administration meeting both co-primary pharmacokinetic (PK) endpoints, as well as a five-fold reduction in infusion-related reactions and fewer venous thromboembolic events1 CHMP has issued a positive opinion for an extension of marketing authorisation for subcutaneous amivantamab dosed every two weeks

The first FcRn blocker to demonstrate sustained disease control over 24 weeks in antibody positive adult patients: anti-AChR+, anti-MuSK+, anti-LRP4+ Nipocalimab demonstrated a sustained reduction in autoantibody levels, one of the underlying causes of gMG, by up to 75% over a period of 24 weeks The investigational therapy was recently granted U.S. FDA Priority Review for the treatment of gMG

Following U.S. FDA Priority Review, approval is based on data demonstrating SPRAVATO® alone met its primary endpoint at 4 weeks and led to rapid and superior improvement in depressive symptoms compared to placebo as early as 24 hours1 SPRAVATO® alone showed a rapid and superior improvement vs. placebo in the Montgomery-Asberg Depression Rating Scale (MADRS) total score, with numerical improvements across all 10 MADRS items seen at day 28 in a post-hoc analysis2 Monotherapy data adds to well-established clinical efficacy and real-world safety profile of SPRAVATO®

Latest topline data from the Phase 3 MARIPOSA study shows amivantamab plus lazertinib is the first regimen to demonstrate superior overall survival benefit compared to the current standard of care osimertinib1 Median overall survival improvement is expected to exceed one year1

Application accepted for U.S. FDA Real-Time Oncology Review (RTOR) based on Phase 2b SunRISe-1 study showing highest single-agent complete response rate of 83.5 percent1