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Cabozantinib monotherapy
Cabozantinib monotherapy is a Small molecule drug developed by Ipsen. It is currently in Phase 2 development. Also known as: Cabometyx.
Cabozantinib is a small molecule used in the treatment of various cancers, including Refractory Cutaneous Melanoma, Multiple Myeloma, Metastatic Kidney Cancer, Metastatic Kidney Carcinoma, and Renal Cell Carcinoma. It has been studied in combination with other treatments such as Ipilimumab and Nivolumab 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 | Cabozantinib monotherapy |
|---|---|
| Also known as | Cabometyx |
| Sponsor | Ipsen |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Pan Tumor Rollover Study (PHASE2)
- Extension Study for Participants in Studies That Include Belzutifan (MK-6482-043/LITESPARK-043) (PHASE3)
- A Phase 1 Study of AB521 Monotherapy and Combination Therapies in Renal Cell Carcinoma and Other Solid Tumors (PHASE1)
- Study of Cabozantinib as Monotherapy or in Combination With Nivolumab in Patients With Advanced or Metastatic Renal Cell Carcinoma Under Real-life Clinical Setting in 1st Line Treatment.
- Observational Real-life Study of Cabozantinib in Monotherapy or in Combination With Nivolumab in Advanced Renal Cell Carcinoma (RCC)
- A Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study (PHASE3)
- KO-2806 Monotherapy and Combination Therapies in Advanced Solid Tumors (PHASE1)
- Study of Atezolizumab in Combination With Cabozantinib Versus Docetaxel in Patients With Metastatic Non-Small Cell Lung Cancer Previously Treated With an Anti-PD-L1/PD-1 Antibody and Platinum-Containing Chemotherapy (PHASE3)
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:
- Cabozantinib monotherapy CI brief — competitive landscape report
- Cabozantinib monotherapy updates RSS · CI watch RSS
- Ipsen portfolio CI
Frequently asked questions about Cabozantinib monotherapy
What is Cabozantinib monotherapy?
Who makes Cabozantinib monotherapy?
Is Cabozantinib monotherapy also known as anything else?
What development phase is Cabozantinib monotherapy in?
Related
- Manufacturer: Ipsen — full pipeline
- Also known as: Cabometyx
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing