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Teclistamab was the first off-the-shelf bispecific for multiple myeloma, and is now approved after just one prior line of therapy.
Teclistamab is a humanised IgG4 DuoBody bispecific that binds BCMA on myeloma cells with one arm and CD3 on T cells with the other, forming an artificial immune synapse that kills the tumour cell independent of MHC. It was the first off-the-shelf bispecific for myeloma, given subcutaneously after step-up doses of 0.06 and 0.3 mg/kg, then 1.5 mg/kg weekly, with less frequent dosing in sustained responders. Accelerated approval in 2022 rested on MajesTEC-1 in heavily pretreated myeloma (objective response rate 63 percent), and in the first quarter of 2026 the label expanded to relapsed or refractory myeloma after at least one prior therapy, with daratumumab, based on MajesTEC-3. Cytokine release syndrome occurred in 72 percent of MajesTEC-1 patients but was severe in under 1 percent, and serious infections affected 30 to 54 percent across trials, so infection prophylaxis is essential.
Backbone ribbon from PDB 12ER. RCSB PDB 12ER. The ribbon widens where the chain is folded into a regular pattern and narrows where it is a loose loop.
1.One arm binds BCMA on the tumour cell
Source: US prescribing information (DailyMed). Doses are for orientation; the current label governs.
Given by infusion or injection in a clinic or hospital outpatient department, so it is a Part B drug: Medicare pays 80% after the Part B deductible and the patient owes 20% coinsurance, uncapped in Original Medicare unless a Medigap policy applies. Step-up dosing is often started in hospital (Part A) because of cytokine release syndrome monitoring, then continued in the outpatient setting.
Covered under the medical benefit with prior authorisation confirming diagnosis, biomarker status and line of therapy; site-of-care policies may steer infusions away from hospital outpatient departments. Four or more prior lines of therapy documented for the myeloma label.
20% Part B coinsurance on a high-cost infusion adds up quickly: Medigap Plan G or N, Medicare Advantage maximum out-of-pocket, Medicaid dual eligibility, or a charity fund are the usual buffers.
Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B). Not medical or financial advice; verify with your plan.
Sources: NICE TA1015. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
Breakthrough Therapy designation source
Conditional approval: first BCMA bispecific worldwide source
Adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody
Accelerated approval, relapsed/refractory myeloma after ≥4 lines (MajesTEC-1) source
Biweekly dosing added for responders source
Relapsed/refractory myeloma after ≥1 prior line, with daratumumab (MajesTEC-3) source
Adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody
Confirmed: the accelerated approval of 2022 converted to traditional approval 3.4 years after it was granted.
| Region | Year | Indication |
|---|---|---|
| US | 2022 | Relapsed/refractory myeloma after ≥4 lines |
| US | 2026 | Relapsed/refractory myeloma after ≥1 prior therapy |
| EU | 2022 | R/R myeloma ≥3 lines (conditional, Aug 2022) · Conditional marketing authorisation |
| Adverse event | Any grade | Grade 3+ |
|---|---|---|
| Pyrexia MajesTEC-1 | 76% | 3% |
| Cytokine release syndrome MajesTEC-1 | 72% | 0.6% |
| Neutrophils decreased MajesTEC-1 | 88% | 70% |
| Musculoskeletal pain MajesTEC-1 | 44% | 4.2% |
| Injection site reaction MajesTEC-1 | 37% | 0.6% |
| Fatigue MajesTEC-1 | 33% | 2.4% |
| Pneumonia MajesTEC-1 | 24% | 15% |
| Neurologic toxicity ICANS 6% | 60% | 6% |
| Serious infections 30-54% across trials; fatal 4-5% | - | - |
Rates read from the US prescribing information. Blank cells mean the figure was not sourced, not that it is zero.
Read for the class this product belongs to (bispecific t-cell engagers) unless the answer names the product. Population figures from the cohorts named, not a prediction for one person. Blank where no source gives a recovery figure.
| Country | Reimbursement | List price | Assistance |
|---|---|---|---|
| United States | Medicare Part B (physician-administered); commercial plans per formulary | not disclosed | janssencarepath.com |
| United Kingdom | NICE: recommended for relapsed/refractory myeloma after ≥3 therapies (TA1006) | not disclosed | - |
List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.
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Elranatamab confirmed that BCMA bispecifics are a class, not a one-off, and its protocol-built dose reduction after response set a precedent for lowering the immunosuppressive burden of T-cell engagers. Patients now have two approved BCMA bispecifics and one against GPRC5D (talquetamab). Choosing between them, and sequencing them with CAR-T, remains guided by availability and toxicity profile rather than head-to-head data.
Teclistamab showed that an off-the-shelf bispecific can approach CAR-T-like response rates in late myeloma, giving patients who cannot wait for or access cell therapy a real option. It also exposed the price: prolonged T-cell engagement causes profound immunosuppression, so infection prophylaxis and immunoglobulin replacement are now routine. Less frequent dosing after response is being adopted to reduce this burden.
Query for this drug: (TITLE:"Teclistamab" OR ABSTRACT:"Teclistamab" OR TITLE:"Tecvayli" OR ABSTRACT:"Tecvayli") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Teclistamab, not a curated reading list.
Shares A Study of the Combination of Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma, BCMA-directed therapy → GPRC5D-directed therapy, ISB 2001, A Study Comparing Talquetamab Plus Pomalidomide, Talquetamab Plus Teclistamab, and Elotuzumab, Pomalidomide, and Dexamethasone or Pomalidomide, Bortez.
Shares Caution: T-cell redirectors and infections, BCMA expression, Step-up dosing (T-cell engagers), MagnetisMM-3: elranatamab, a second BCMA bispecific, with a switch to fortnightly dosing after response.
Shares Yale University Open Data Access (YODA) Project, A Study of Different Sequences of Cilta-cel, Talquetamab in Combination With Daratumumab and Teclistamab in Combination With Daratumumab Following Ind, BCMA expression, IUCT Oncopole (Institut Universitaire du Cancer de Toulouse).
Shares BCMA-directed therapy → GPRC5D-directed therapy, Comprehensive Cancer Center Mainfranken, University Hospital Würzburg, MagnetisMM-3: elranatamab, a second BCMA bispecific, with a switch to fortnightly dosing after response, Relapsed or refractory multiple myeloma.
Shares Caution: T-cell redirectors and infections, BCMA expression, BCMA, CD3.
Shares BCMA-directed therapy → GPRC5D-directed therapy, Relapsed or refractory multiple myeloma, Johnson & Johnson, T-cell engagers (bispecific).
Shares Sundar Jagannath, A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With, Plasma cell leukaemia, Relapsed or refractory multiple myeloma.
Shares ISB 2001, Philippe Moreau, Newly diagnosed multiple myeloma, transplant-ineligible, Plasma cell leukaemia.