Also known as: Carvykti, CARVYKTI
Cilta-cel is the common short name for ciltacabtagene autoleucel, an autologous BCMA-directed CAR-T cell therapy marketed as Carvykti for relapsed/refractory multiple myeloma. It is a personalized cellular therapy made from each patient's own T cells. The product is approved in the U.S. and EU and is prescription-only.
A phase 2 trial in high-risk smoldering multiple myeloma found all 20 patients treated with cilta-cel became MRD-negative within two months and remained so after 15.3 months. No disease progression, death, dose-limiting toxicities, or high-grade side effects were observed.
Johnson & Johnson raised its full-year forecast after stronger-than-expected quarterly results driven by cancer, immunology and neuroscience drugs. Sales were $24.56 billion and adjusted earnings were $2.46 per share, with Innovative Medicines sales rising 10.0% to $15.76 billion.
Johnson & Johnson shares hit a 52-week high after the company reported 2025 revenue of $94.19 billion and forecast 2026 revenue above $100 billion. The company also filed a shelf registration and said Innovative Medicine growth offset pressure from Stelara.
Johnson & Johnson reported strong Q4 2025 earnings with $2.46 adjusted EPS and $24.56 billion in sales, beating estimates. The company faces over 67,000 active talc lawsuits following recent trial losses while projecting 2026 sales of $100-101 billion and maintaining a robust pipeline with recent FDA approvals and breakthrough designations.
CAR T-cell therapy demonstrates near-98% response rates in multiple myeloma trials, but only 2.6% of eligible patients receive treatment. Black patients face substantially lower access, with structural and institutional barriers limiting availability of the specialized therapy.
Global orphan drug sales are forecast to reach $409 billion by 2032, representing one-fifth of prescription drug sales, with Johnson & Johnson and Argenx leading the market amid regulatory uncertainty.
CAR T-cell therapy is delivering unprecedented results for multiple myeloma patients, with CARTITUDE-1 trial data showing one-third of patients remaining progression-free for five years or more, raising the possibility of cure for some patients.
Novel CELMoD agents are being evaluated to address T-cell exhaustion in multiple myeloma patients, while CAR T-cell therapy CARVYKTI shows longer-term survival benefits. Nearly 200,000 people in the U.S. live with this blood cancer.
CAR T-cell therapy is delivering high remission rates for multiple myeloma patients, with improved handoff communication reducing infection risks. FDA-approved BCMA-targeting products show response rates from 72% to 98% in heavily pretreated patients.
Johnson & Johnson announced a more than $1 billion investment to build a new cell therapy manufacturing facility in Lower Gwynedd, Pennsylvania, creating 500 skilled biomanufacturing jobs and 4,000 construction jobs as part of its $55 billion U.S. investment strategy through early 2029.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07093554 |
Cilta-Talq Fusion Study: A Phase 1b Study of Talquetamab Bridging Therapy Followed by Ciltacabtagene Autoleucel in Patients With Relapsed/Refractory Multiple Myeloma |
RECRUITING | PHASE1 |
| NCT06940297 |
Dasatinib and Quercetin With CAR-T Therapy for the Treatment of Patients With Relapsed or Refractory Multiple Myeloma |
RECRUITING | PHASE2 |
| NCT06855121 |
The Norwegian Immunotherapy in Multiple Myeloma Study |
RECRUITING | |
| NCT06623630 |
Lymphodepleting Total Body Irradiation (TBI) Plus Cyclophosphamide Prior to Ciltacabtagene Autoleucel (Carvykti; Cilta-cel) for Multiple Myeloma (MM) Patients With Impaired Renal Function |
RECRUITING | PHASE1 |
| NCT05767359 |
CAR- PRISM (PRecision Intervention Smoldering Myeloma) |
ACTIVE_NOT_RECRUITING | PHASE2 |
