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Axitinib plus Toripalimab (axitinib-plus-toripalimab)
Axitinib plus Toripalimab (generic name: axitinib-plus-toripalimab) is a Monoclonal antibody drug developed by Pfizer Inc.. It is currently in Phase 3 development.
Axitinib plus Toripalimab targets VEGF receptors and PD-1, inhibiting angiogenesis and enhancing immune response against cancer cells.
Axitinib plus Toripalimab is being studied in clinical trials for various conditions, including kidney cancer and melanoma. Toripalimab is a programmed cell death protein 1 (PD-1) antagonist, a type of antibody that works by blocking the PD-1 protein.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% 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 | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | axitinib-plus-toripalimab |
|---|---|
| Sponsor | Pfizer Inc. |
| Modality | Monoclonal antibody |
| Phase | Phase 3 |
| Annual revenue | 923 |
Mechanism of action
Axitinib blocks VEGF receptors to prevent blood vessel growth in tumors, while Toripalimab binds to PD-1 to activate T-cells, improving the body's ability to fight cancer.
Approved indications
Common side effects
Key clinical trials
- Neoadjuvant of Axitinib Plus PD-1 to Improve Disease Free Survival of Patients With Renal Cell Carcinoma (PHASE3)
- Study to Evaluate the Efficacy and Safety of Toripalimab in Combination With Axitinib Versus Sunitinib Monotherapy in Advanced Renal Cell Cancer (PHASE3)
- A Study to Assess LBL-007 in Combination With Toripalimab and Axitinib Tablets Subjects With Advanced Melanoma (PHASE1)
- Preoperative Therapy of Super-selective Tumor Artery Embolization Combined With Toripalimab and Axitinib in Advanced RCC (PHASE2)
- SABR Combined with Axitinib and Toripalimab in Recurrent or Metastatic RCC (PHASE2)
- Study to Evaluate the Efficacy and Safety of Immunotherapy With Axitinib in Advanced Collecting Duct Carcinoma (PHASE2)
- Combination of Toripalimab and JS004 Therapy for ccRCC (PHASE2)
- Upfront Immune Checkpoint Inhibitors With Deferred Cytoreductive Nephrectomy for Metastatic Renal Cell Carcinoma (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 |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Axitinib plus Toripalimab CI brief — competitive landscape report
- Axitinib plus Toripalimab updates RSS · CI watch RSS
- Pfizer Inc. portfolio CI
Frequently asked questions about Axitinib plus Toripalimab
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Related
- Manufacturer: Pfizer Inc. — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing