Teclistamab
Teclistamab was the first off-the-shelf bispecific for multiple myeloma, and is now approved after just one prior line of therapy.
Approved 2022 for heavily pretreated myeloma (MajesTEC-1, ORR 63%). In Q1 2026 label expanded to relapsed/refractory myeloma after ≥1 prior therapy (MajesTEC-3, with daratumumab). Infection prophylaxis is essential.
1.One arm binds BCMA on the tumour cell
- Route
- Subcutaneous injection
- Schedule
- Step-up 0.06 then 0.3 mg/kg, then 1.5 mg/kg weekly; may move to 3 mg/kg every 2 weeks after ≥6 months of response, then every 4 weeks
- Dose modifications
- Hold for grade ≥2 CRS/ICANS; IVIG for hypogammaglobulinaemia; antimicrobial prophylaxis
- Monitoring
- 48-hour hospitalisation after each step-up dose; infections, IgG levels, blood counts
Source: US prescribing information (DailyMed). Doses are for orientation; the current label governs.
- Medicare
- Part B (clinician-administered)
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.
- Commercial insurance
- covered with prior authorisation
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.
- Assistance programmes
- Johnson & Johnson withMe
- Johnson & Johnson Patient Assistance Foundation
- PAN Foundation — Disease-specific co-pay and premium funds; open and closed funds change monthly.
- HealthWell Foundation
- CancerCare Co-Payment Assistance Foundation
- Patient Advocate Foundation Co-Pay Relief
- Leukemia & Lymphoma Society financial support
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.
- Notes
- Licensed 2022 for relapsed or refractory myeloma after 3 or more treatments; NICE recommended it (via managed access) in 2024. TA number not verified.
Sources: NICE search: teclistamab. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
- Jun 2021DesignationUS
Breakthrough Therapy designation source
- 24 Aug 2022ApprovalEU
Conditional approval: first BCMA bispecific worldwide source
- 25 Oct 2022ApprovalUS
Accelerated approval, relapsed/refractory myeloma after ≥4 lines (MajesTEC-1) source
- 20 Feb 2024Label changeUS
Biweekly dosing added for responders source
- Q1 2026ApprovalUS
Relapsed/refractory myeloma after ≥1 prior line, with daratumumab (MajesTEC-3) source
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2022 | Relapsed/refractory myeloma after ≥4 lines |
| US | 2026 | Relapsed/refractory myeloma after ≥1 prior therapy |
| 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.
| 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.
Trials
topRecruiting now (live from ClinicalTrials.gov)
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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.
Latest papers
topQuery 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.
Pages like this
not linked directly; found by shared links- ProductTalquetamab
Shares BCMA-directed therapy → GPRC5D-directed therapy, MagnetisMM-3: elranatamab, a second BCMA bispecific, with a switch to fortnightly dosing after response, MajesTEC-1: teclistamab, an off-the-shelf BCMA bispecific antibody, in heavily pretreated myeloma, Johnson & Johnson.
- ProductElranatamab
Shares Caution: T-cell redirectors and infections, MagnetisMM-3: elranatamab, a second BCMA bispecific, with a switch to fortnightly dosing after response, MajesTEC-1: teclistamab, an off-the-shelf BCMA bispecific antibody, in heavily pretreated myeloma, BCMA.
- TargetGPRC5D
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, T-cell engagers (bispecific).
- ProductCiltacabtagene autoleucel
Shares Yale University Open Data Access (YODA) Project, IUCT Oncopole – Institut Universitaire du Cancer de Toulouse, Comprehensive Cancer Center Mainfranken, University Hospital Würzburg, Cell therapy roadmap: CD19 CAR-T → solid tumours → in vivo CAR.
- ProductLinvoseltamab
Shares Caution: T-cell redirectors and infections, BCMA, CD3, T-cell engagers (bispecific).
- ProductGlofitamab
Shares Step-up dosing (T-cell engagers), IRCCS Azienda Ospedaliero-Universitaria di Bologna – Policlinico Sant'Orsola, CD3, T-cell engagers (bispecific).
- Key paperCARTITUDE-1: cilta-cel, a BCMA CAR-T, in heavily pretreated myeloma
Shares Saad Z. Usmani, Johnson & Johnson, BCMA, Multiple myeloma.
- TechnologyBispecific antibodies
Shares Step-up dosing (T-cell engagers), IUCT Oncopole – Institut Universitaire du Cancer de Toulouse, IRCCS Azienda Ospedaliero-Universitaria di Bologna – Policlinico Sant'Orsola, Comprehensive Cancer Center Mainfranken, University Hospital Würzburg.