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Axalimogene filolisbac
Axalimogene filolisbac is a Cancer vaccine Small molecule drug developed by Advaxis, Inc.. It is currently in Phase 2 development for Cervical cancer. Also known as: ADXS11-001.
Lysosomal targeting of tumor cells via Listeria monocytogenes
Lysosomal targeting of tumor cells via Listeria monocytogenes Used for Cervical cancer.
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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). -
Oncology Phase 2 attrition
-2.0pp
Oncology drugs have higher Phase 2-to-Phase 3 attrition than average — many fail to show OS benefit in larger studies.
| 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 | Axalimogene filolisbac |
|---|---|
| Also known as | ADXS11-001 |
| Sponsor | Advaxis, Inc. |
| Drug class | Cancer vaccine |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 2 |
Mechanism of action
Axalimogene filolisbac is a live, attenuated Listeria monocytogenes-based immunotherapy that selectively targets and kills tumor cells by inducing a strong immune response.
Approved indications
- Cervical cancer
Common side effects
- Fatigue
- Nausea
- Vomiting
Key clinical trials
- Axalimogene Filolisbac (ADXS11-001) High Dose in Women With Human Papillomavirus (HPV) + Cervical Cancer (PHASE1)
- A Phase 2 Study of Axalimogene Filolisbac (ADXS11-001) in Participants With Carcinoma of the Anorectal Canal (PHASE2)
- ADXS 11-001 Vaccination Prior to Robotic Surgery, HPV-Positive Oropharyngeal Cancer (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:
- Axalimogene filolisbac CI brief — competitive landscape report
- Axalimogene filolisbac updates RSS · CI watch RSS
- Advaxis, Inc. portfolio CI
Frequently asked questions about Axalimogene filolisbac
What is Axalimogene filolisbac?
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What is Axalimogene filolisbac used for?
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Is Axalimogene filolisbac also known as anything else?
What drug class is Axalimogene filolisbac in?
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Related
- Drug class: All Cancer vaccine drugs
- Manufacturer: Advaxis, Inc. — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Cervical cancer
- Also known as: ADXS11-001
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing