Also known as HuMax-CD38, DARZALEX FASPRO, and DARZALEX.
CHMP recommends talquetamab (TALVEY) with daratumumab ± pomalidomide for adults with relapsed/refractory multiple myeloma after ≥1 prior therapy, supported by MonumenTAL-3 efficacy and survival data.
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
FDA approves TECVAYLI plus DARZALEX FASPRO for relapsed multiple myeloma, offering a new treatment option as early as second line with improved safety and efficacy.
The report highlights 2025 achievements, financials, and 2026 outlook, including revenue growth, strategic acquisitions, and regulatory approvals.
2025 DARZALEX sales reached USD 14,351 million, with USD 8,266 million in the U.S. and USD 6,085 million elsewhere. Genmab earns royalties from J&J's global sales.
TECVAYLI® monotherapy reduces disease progression and death risk in multiple myeloma patients refractory to anti-CD38 and lenalidomide, showing superior survival benefits.
