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Teclistamab Monotherapy
Teclistamab Monotherapy is a Small molecule drug developed by Multiple Myeloma Research Consortium. It is currently in Phase 2 development. Also known as: Tecvayli.
Teclistamab is a monoclonal antibody that targets the T cell surface glycoprotein CD3. It is being studied as a treatment for multiple myeloma, including relapsed or refractory multiple myeloma, in clinical trials.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Teclistamab Monotherapy |
|---|---|
| Also known as | Tecvayli |
| Sponsor | Multiple Myeloma Research Consortium |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- A Study Comparing Pre- and Post-Change Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma (PHASE1)
- A Study Comparing QLS32015 Monotherapy Versus Pomalidomide, Dexamethasone (Pd) or Selinexor, Dexamethasone (Sd) in Participants With Relapsed or Refractory Multiple Myeloma (PHASE3)
- A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma (PHASE3)
- Study to Evaluate CCS1477 (Inobrodib) in Haematological Malignancies (PHASE1, PHASE2)
- MMRC Horizon One Adaptive Platform Trial Evaluating Therapies in RRMM (PHASE2)
- Prospective Study of Teclistamab in the Treatment of Systemic AL Amyloidosis (NA)
- Teclistamab Plus Autologous Lymphocyte Infusion (ALI) for the Treatment of R/R Multiple Myeloma (PHASE2)
- Bispecific T-cell Redirectors as Part of First Line Treatment in Transplant Eligible Multiple Myeloma Patients (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Teclistamab Monotherapy CI brief — competitive landscape report
- Teclistamab Monotherapy updates RSS · CI watch RSS
- Multiple Myeloma Research Consortium portfolio CI
Frequently asked questions about Teclistamab Monotherapy
What is Teclistamab Monotherapy?
Who makes Teclistamab Monotherapy?
Is Teclistamab Monotherapy also known as anything else?
What development phase is Teclistamab Monotherapy in?
Related
- Manufacturer: Multiple Myeloma Research Consortium — full pipeline
- Also known as: Tecvayli
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing