Therapy Evidence Tracker

Source-checked note: this page organizes evidence maturity for oncology therapies and was last checked against public regulator/trial sources on 2026-05-22. It is not medical advice, treatment selection, or a recommendation to seek unapproved interventions.

TL;DR

The safest question is not "is this a breakthrough?" It is: what is approved, for which disease, in which region, based on what endpoint, and with what toxicity or access limits?

This tracker uses conservative labels so experimental biology, early clinical signals, pivotal trials, and approved uses do not blur together.

For current availability, labels and regulatory databases outrank this page. Re-check FDA, EMA, PMDA, ANVISA, ClinicalTrials.gov, and product labels before reusing any approval or trial-status claim.

Evidence Labels

Label	Meaning	What must be checked
Approved, standard or near-standard	Regulatory approval for a defined indication, often in guidelines	Agency label, indication, line of therapy, biomarker, contraindications
Approved, region-limited	Approval exists in one jurisdiction but not necessarily elsewhere	PMDA/FDA/EMA/ANVISA status, local availability, post-marketing data
Pivotal or late clinical	Phase III or registrational trial, but adoption still depends on regulators and guidelines	Primary endpoint, comparator, safety, subgroup claims
Early clinical	Phase I/II signal or dose-finding	Response durability, selection bias, dose, adverse events
Translational	Human samples, organoids, animal models, or mechanistic rationale	Model limits, reproducibility, delivery feasibility
Preclinical	Cell line, animal, or computational-only evidence	No patient benefit demonstrated
Speculative	Hypothesis or platform concept	Needs basic validation before clinical language

Modality Snapshot

Area	Conservative status	Main caveat
CAR-T / cellular therapy	Multiple FDA-approved CAR-T products exist for hematologic malignancies; TIL and engineered TCR therapies have specific solid-tumor approvals	Solid-tumor CAR-T remains mostly investigational; toxicity and manufacturing are central constraints
Oncolytic viruses	T-VEC is FDA/EMA-approved for selected melanoma use; Japan has specific approvals for some local products	Most combinations and systemic OV strategies are still clinical research
Tumor Treating Fields	Device approvals exist for glioblastoma and selected additional indications; use is indication-specific	Benefit depends on disease context, trial design, and device adherence
Photodynamic therapy	Approved use is agent-, light-, anatomy-, and indication-specific	It is not a systemic all-cancer therapy
Nanomedicine	Several nano-formulated drugs are approved; many "smart" or triggered platforms remain investigational	"Nano" describes delivery/material scale, not automatic efficacy
Acoustic therapy / histotripsy / HIFU	Approved devices exist for selected indications; oncology use is specific to device label and anatomy	Ablation success depends on targeting, monitoring, and local disease context
BNCT	Approved in Japan for selected head-and-neck cancer settings; trial and infrastructure development elsewhere	Requires boron delivery, neutron source, dosimetry, and specialized centers
FLASH radiotherapy	Early clinical and strong translational interest	Human efficacy and late-toxicity evidence remain immature
Targeted protein degradation	Vepdegestrant became the first FDA-approved PROTAC-type heterobifunctional degrader in 2026 for a defined breast-cancer indication	Other degraders remain target- and trial-specific
CRISPR cancer editing	Ex vivo edited immune-cell programs are in trials	No general CRISPR cancer cure; delivery and off-target risk remain central
Microbiome modulation	FMT and engineered microbiome strategies are investigational in oncology	Association with immunotherapy response is not the same as validated treatment
Senolytics	Mostly translational or early clinical in oncology/supportive-care contexts	Senescence can be tumor-suppressive or tumor-promoting depending on timing and tissue

How to Read a Strong Claim

Ask these before trusting a claim:

1. Is the evidence regulatory, clinical, translational, or preclinical?
2. What exact cancer type, stage, biomarker, and line of therapy were studied?
3. Was the endpoint overall survival, progression-free survival, response rate, toxicity, quality of life, or only a biomarker?
4. Was the comparator appropriate?
5. Is the source a primary paper, regulator label, guideline, registry entry, conference abstract, press release, or blog?
6. Does the page separate patient benefit from mechanism?

Brazil and Access Notes

Brazilian clinical use depends on ANVISA registration, local incorporation decisions, hospital capability, reimbursement, and whether the intervention is available only through research. A therapy being approved by FDA, EMA, or PMDA does not automatically mean it is available or standard in Brazil.

References

1. U.S. Food and Drug Administration. Approved Cellular and Gene Therapy Products. https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/approved-cellular-and-gene-therapy-products
2. U.S. Food and Drug Administration. IMLYGIC. https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/imlygic
3. National Cancer Institute. Clinical trial phases. https://www.cancer.gov/about-cancer/treatment/clinical-trials/what-are-trials/phases
4. Pharmaceuticals and Medical Devices Agency. Sakigake Designation Products: BNCT medical products. https://www.pmda.go.jp/files/000237994.pdf
5. Mascia AE, Daugherty EC, Zhang Y, et al. Proton FLASH radiotherapy for the treatment of symptomatic bone metastases: the FAST-01 nonrandomized trial. JAMA Oncology. 2023. PMID: 36273324. https://pubmed.ncbi.nlm.nih.gov/36273324/
6. U.S. Food and Drug Administration. FDA approves vepdegestrant for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer. May 1, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-vepdegestrant-er-positive-her2-negative-esr1-mutated-advanced-or-metastatic-breast
7. U.S. Food and Drug Administration. Drugs@FDA: FDA-Approved Drugs. https://www.accessdata.fda.gov/scripts/cder/daf/