Last reviewed · How we verify
Yondelis®-Caelyx®
Yondelis®-Caelyx® is a Small molecule drug developed by ARCAGY/ GINECO GROUP. It is currently in Phase 2 development. Also known as: Observation of Yondelis®-Caelyx® administration.
Yondelis (Caelyx) is used to treat various types of cancer, including relapsed ovarian cancer, recurrent ovarian cancer, and soft tissue leiomyosarcoma. It is administered in combination with other treatments, such as doxorubicin and PLD, or as a rechallenge with PLD added to trabectedin.
-
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 | Yondelis®-Caelyx® |
|---|---|
| Also known as | Observation of Yondelis®-Caelyx® administration |
| Sponsor | ARCAGY/ GINECO GROUP |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Reprab Study: PLD + Trabectedin Rechallenge (PHASE2)
- Ovarian Cancer Treatment Platinum-sensitive Relapse - Cohort Study (PROSPECTYON)
- An Observational Study of YONDELIS®+PLD for the Treatment of Patients With Platinum-sensitive Relapse of Ovarian Cancer
- Study of Doxorubicin and Trabectedin in First Line Treatment on Patients With Metastatic Leiomyosarcoma (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:
- Yondelis®-Caelyx® CI brief — competitive landscape report
- Yondelis®-Caelyx® updates RSS · CI watch RSS
- ARCAGY/ GINECO GROUP portfolio CI
Frequently asked questions about Yondelis®-Caelyx®
What is Yondelis®-Caelyx®?
Who makes Yondelis®-Caelyx®?
Is Yondelis®-Caelyx® also known as anything else?
What development phase is Yondelis®-Caelyx® in?
Related
- Manufacturer: ARCAGY/ GINECO GROUP — full pipeline
- Also known as: Observation of Yondelis®-Caelyx® administration
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing