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Lysate of Tumor
Lysate of Tumor is a Biologic drug developed by Macarena De La Fuente, MD. It is currently in Phase 1 development. Also known as: Lysate, Tumor Lysate.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | Lysate of Tumor |
|---|---|
| Also known as | Lysate, Tumor Lysate |
| Sponsor | Macarena De La Fuente, MD |
| Modality | Biologic |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Evaluation of a Cancer Lysate Vaccine and Montanide (Registered Trademark) ISA-51 VG With or Without the IL-15 Super-Agonist N-803 as Adjuvant Therapy for PD-L1 Negative Non-Small Cell Lung Cancer (PHASE1, PHASE2)
- Immunotherapy With Autologous Tumor Lysate-Loaded Dendritic Cells In Patients With Newly Diagnosed Glioblastoma Multiforme (PHASE1, PHASE2)
- DOC1021 Dendritic Cell Immunotherapy for Treatment of Newly Diagnosed Adult Glioblastoma (GBM) (PHASE2)
- DOC1021 Dendritic Cell Immunotherapy for Refractory Melanoma (PHASE1, PHASE2)
- NEOadjuvant Dendritic Cell Vaccination for Ovarian Cancer (PHASE1, PHASE2)
- Autologous TLPO Vaccine Basket (PHASE2)
- Pembrolizumab and a Vaccine (ATL-DC) for the Treatment of Surgically Accessible Recurrent Glioblastoma (PHASE1)
- Th-1 Dendritic Cell Immunotherapy Plus Standard Chemotherapy for Pancreatic Adenocarcinoma (PHASE1)
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:
- Lysate of Tumor CI brief — competitive landscape report
- Lysate of Tumor updates RSS · CI watch RSS
- Macarena De La Fuente, MD portfolio CI
Frequently asked questions about Lysate of Tumor
What is Lysate of Tumor?
Who makes Lysate of Tumor?
Is Lysate of Tumor also known as anything else?
What development phase is Lysate of Tumor in?
Related
- Manufacturer: Macarena De La Fuente, MD — full pipeline
- Also known as: Lysate, Tumor Lysate
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing