Also known as TECVAYLI and teclistamab.
Modeling of MajesTEC‑3 trial data estimates a high cure fraction and nearly fourfold median OS benefit for teclistamab plus daratumumab FASPRO versus standard care in relapsed/refractory myeloma.
Phase 3 MonumenTAL-6 shows BCMA+GPRC5D bispecific combo and talquetamab+pomalidomide both significantly improved PFS versus investigator’s choice in patients with 1–4 prior lines.
Quarterly sales topped $25.3B; adjusted net earnings and EPS rose, free cash flow improved, and full-year revenue guidance was raised above $100B for the first time.
CHMP recommendation follows MajesTEC-3 Phase 3 data showing HR 0.17 for PFS and HR 0.46 for OS at ~3 years in adults with RRMM after ≥1 prior therapy, with manageable safety.
Phase 3 MajesTEC‑9: teclistamab cut progression/death risk 71% (HR 0.29) and death 40% (HR 0.60) vs PVd/Kd in early RRMM; higher ≥CR (65.9% vs 16.8%); infections and CRS increased
