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Trabectedin and PLD
Trabectedin and PLD is a Small molecule drug developed by Grupo Español de Investigación en Cáncer de Ovario. It is currently in Phase 2 development.
Trabectedin, also known as Yondelis, is a medication used to treat relapsed ovarian cancer, particularly in patients who have received prior platinum-based chemotherapy. It is often administered in combination with carboplatin, as seen in clinical trials such as NCT00170573, to evaluate its efficacy and quality of life benefits in this patient population.
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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 | Trabectedin and PLD |
|---|---|
| Sponsor | Grupo Español de Investigación en Cáncer de Ovario |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- QoL-Comparison Between Trabectedin/PLD and Pt-based Therapy in Patients With Pt-sensitive Recurrent Ovarian Cancer (PHASE4)
- Caelyx Biweekly in Heavily Pretreated Patients With Relapsed Ovarian Cancer (PHASE2)
- Retrospective Multicenter Study of Elderly Patients With Ovarian Cancer Treated With Trabectedin and PLD
- Evaluation of Symptom Benefit Rate of Trabectedin/PLD in Patients With Recurrent Ovarian Cancer (PHASE3)
- Reprab Study: PLD + Trabectedin Rechallenge (PHASE2)
- Retrospective Study to Analyze the Efficacy and Safety of Trabectedin and Pegylated Liposomal Doxorubicin (PLD ) in the Treatment of Patients With Platinum-sensitive Recurrent Ovarian Cancer (ROC), According to SmPC
- An Observational Study of Combination of Pegylated Liposomal Doxorubicin and Trabectedin in Routine Practice in Patients With Recurrent Partial-platinum Sensitive Ovarian Cancer
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:
- Trabectedin and PLD CI brief — competitive landscape report
- Trabectedin and PLD updates RSS · CI watch RSS
- Grupo Español de Investigación en Cáncer de Ovario portfolio CI
Frequently asked questions about Trabectedin and PLD
What is Trabectedin and PLD?
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What development phase is Trabectedin and PLD in?
Related
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing