EC 200-003-9
Also known as Decadron and Dexasone.
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.
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.
GPRC5D bispecific plus anti‑CD38 combo cut progression risk and delivered 24‑month PFS up to 81% and OS up to 89% in earlier‑line relapsed/refractory multiple myeloma.
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
FDA approves KEYTRUDA regimens for platinum-resistant ovarian cancer, showing reduced disease progression and death risk in trials.
