Also known as: teclistamab-cqyv, Tecvayli, TECVAYLI
Teclistamab-cqyv is marketed as TECVAYLI, a bispecific BCMA-directed CD3 T-cell engager for relapsed or refractory multiple myeloma after at least four prior lines of therapy. It is approved under accelerated approval based on response outcomes, with confirmatory verification required for continued approval. U.S. initial approval was in 2022.
A systematic review and meta-analysis found high infection rates with teclistamab in relapsed/refractory multiple myeloma. Five studies showed pooled infection rates of 56.5% for any grade and 27.6% for grade 3 or higher.
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 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.
The multiple myeloma treatment landscape is rapidly expanding with over 75 companies developing 80+ pipeline therapies, while clinicians navigate evolving questions about transplant timing, quadruplet regimens, and minimal residual disease testing in newly diagnosed patients.
MajesTEC-9 trial demonstrates teclistamab's superiority over standard care in second-line multiple myeloma treatment, with significant progression-free survival and overall survival benefits supporting earlier use of the BCMA-targeting bispecific antibody.
The FDA approved Tecvayli plus Darzalex Faspro for relapsed or refractory multiple myeloma after at least one prior therapy, and accepted a new drug application for iberdomide plus daratumumab and dexamethasone with a PDUFA date of August 17, 2026.
The FDA approved Tecvayli plus Darzalex Faspro for relapsed/refractory multiple myeloma in March 2026, and Darzalex Faspro-based quadruplet D-VRd for newly diagnosed transplant-ineligible patients in January 2026.
The FDA has approved a new monthly dosing schedule for Johnson & Johnson's Rybrevant Faspro combined with Lazcluze for first-line treatment of advanced EGFR-mutated non-small cell lung cancer, allowing patients to transition to monthly dosing as early as week five.
T-cell immunotherapies including CAR T-cell therapy and T-cell engagers are expanding cancer treatment options but present significant cardiovascular risks and operational complexities requiring coordinated multidisciplinary management.
A 24-year-old woman with refractory lupus achieved two successful pregnancies following dual-target CAR-T cell therapy, while bispecific T cell engagers showed efficacy in treatment-refractory antisynthetase syndrome and systemic sclerosis patients.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07581704 |
Sirolimus Pre-conditioning on T Cell Activity and T-cell Engaging Bispecific Antibody Efficacy in Multiple Myeloma |
NOT_YET_RECRUITING | PHASE1 |
| NCT07518186 |
A Study Comparing JNJ-79635322 and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma |
NOT_YET_RECRUITING | PHASE3 |
| NCT07463807 |
Testing the Investigational Medication Combination of Teclistamab and Pomalidomide Compared to the Usual Treatment (Carfilzomib, Pomalidomide, and Dexamethasone) for Patients With Multiple Myeloma Who Have Relapsed Shortly After Treatment |
NOT_YET_RECRUITING | PHASE1/PHASE2 |
| NCT07332507 |
Testing the Effect of Teclistamab on Recurrent Plasmablastic Lymphoma |
NOT_YET_RECRUITING | PHASE1 |
| NCT07258511 |
A Study Comparing JNJ-79635322 and an Anti-B-cell Maturation Antigen (BCMA)xCD3 Bispecific Antibody in Participants With Relapsed or Refractory Multiple Myeloma |
RECRUITING | PHASE3 |
| NCT07110844 |
Teclistamab-Daratumumab in AL Amyloidosis |
RECRUITING | PHASE2 |
| NCT07107529 |
Study for Frail Patients With Newly Diagnosed Multiple Myeloma Treated With Daratumumab With Teclistamab or Talquetamab. |
RECRUITING | PHASE2 |
| NCT07105059 |
A Study of Teclistamab and Mezigdomide in People With Multiple Myeloma |
RECRUITING | PHASE1 |
| NCT07030517 |
A Study to Assess Safety of Teclistamab in Indian Participants With Relapsed and Refractory Multiple Myeloma |
RECRUITING | PHASE4 |
| NCT06993675 |
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE) |
RECRUITING | PHASE2 |
