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Utomilumab (utomilumab)
Utomilumab (generic name: utomilumab) is a Monoclonal antibody drug developed by Pfizer Inc.. It is currently in Phase 2 development.
Utomilumab is an antibody that acts as an agonist to the tumor necrosis factor receptor superfamily member 9 (TNFRSF9), also known as CD137. It is being studied in clinical trials for various types of lymphoma, including Recurrent Diffuse Large B-Cell Lymphoma, Recurrent Mantle Cell Lymphoma, and others.
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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). -
Big-pharma sponsor
+3.0pp
Pfizer Inc. is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| 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 | utomilumab |
|---|---|
| Sponsor | Pfizer Inc. |
| Modality | Monoclonal antibody |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
- Anorexia
- Dyspnea
- Edema limbs
- Alkaline phosphatase increased
- Anemia
- Aspartate aminotransferase increased
- Blood bilirubin increased
- Constipation
- Fatigue
- Alanine aminotransferase increased
- Hypoalbuminemia
- Insomnia
Key clinical trials
- Utomilumab, Cetuximab, and Irinotecan Hydrochloride in Treating Patients With Metastatic Colorectal Cancer (PHASE1)
- Avelumab, Utomilumab, Anti-OX40 Antibody PF-04518600, and Radiation Therapy in Treating Patients With Advanced Malignancies (PHASE1, PHASE2)
- The AVIATOR Study: Trastuzumab and Vinorelbine With Avelumab OR Avelumab & Utomilumab in Advanced HER2+ Breast Cancer (PHASE2)
- Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing (PHASE3)
- Avelumab With Binimetinib, Sacituzumab Govitecan, or Liposomal Doxorubicin in Treating Stage IV or Unresectable, Recurrent Triple Negative Breast Cancer (PHASE2)
- Avelumab, Utomilumab, Rituximab, Ibrutinib, and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma or Mantle Cell Lymphoma (PHASE1)
- Rituximab + Immunotherapy in Follicular Lymphoma (PHASE1)
- T-Cell Infusion, Aldesleukin, and Utomilumab in Treating Patients With Recurrent Ovarian Cancer (PHASE1, 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:
- Utomilumab CI brief — competitive landscape report
- Utomilumab updates RSS · CI watch RSS
- Pfizer Inc. portfolio CI
Frequently asked questions about Utomilumab
What is Utomilumab?
Who makes Utomilumab?
What is the generic name of Utomilumab?
What development phase is Utomilumab in?
What are the side effects of Utomilumab?
Related
- Manufacturer: Pfizer Inc. — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing