# Intravesical therapy (BCG, chemotherapy, devices, gene and viral therapy)

Source: https://onco.cc/technologies/bcg-and-intravesical-therapy/  
OnCo record `bcg-and-intravesical-therapy` (Technology). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Treating early bladder cancer by putting the drug straight into the bladder through a catheter, so the whole body is spared.

## Summary

BCG remains the backbone for high-risk NMIBC; intravesical gemcitabine or mitomycin for intermediate risk. The BCG-unresponsive space now has four approved options: pembrolizumab (systemic), nadofaragene firadenovec (2022), N-803 + BCG (2024), and the gemcitabine-eluting TAR-200 device (2025), with cretostimogene filing in 2026. Durvalumab + BCG (2026) is the first systemic immunotherapy added to BCG-naive treatment.

## Fields

- Kind: Technology
- Status: standard-of-care
- Last checked: 2026-09-07
- Principle: Direct urothelial exposure to immunostimulants, cytotoxics, viruses, or gene vectors; dwell time and device release kinetics determine efficacy.
- Strengths: Minimal systemic toxicity; Bladder preservation; Repeatable in clinic
- Limitations: BCG shortages; Progression to muscle invasion still occurs; Frequent cystoscopic surveillance

## Sources

- EAU guidelines: non-muscle-invasive bladder cancer: https://uroweb.org/guidelines/non-muscle-invasive-bladder-cancer
- NCI PDQ: bladder cancer treatment: https://www.cancer.gov/types/bladder/patient/bladder-treatment-pdq

## Connected records

- cancers: [Bladder & urothelial cancer](https://onco.cc/cancers/urothelial/), [Non-muscle-invasive bladder cancer](https://onco.cc/cancers/non-muscle-invasive-bladder-cancer/)
- fronts: [Devices & Physical Therapies](https://onco.cc/fronts/devices/), [Immunotherapy](https://onco.cc/fronts/immunotherapy/)
- drugs: [Cretostimogene grenadenorepvec](https://onco.cc/drugs/cretostimogene/), [Gemcitabine](https://onco.cc/drugs/gemcitabine/), [Gemcitabine intravesical system (TAR-200)](https://onco.cc/drugs/tar-200/), [Intravesical BCG](https://onco.cc/drugs/bcg-intravesical/), [Mitomycin C](https://onco.cc/drugs/mitomycin/), [Nadofaragene firadenovec](https://onco.cc/drugs/nadofaragene-firadenovec/), [Nogapendekin alfa inbakicept](https://onco.cc/drugs/nogapendekin-alfa/), [Thiotepa](https://onco.cc/drugs/thiotepa/), [Valrubicin](https://onco.cc/drugs/valrubicin/)
- terms: [BCG-unresponsive](https://onco.cc/terms/bcg-unresponsive/), [Non-muscle-invasive vs muscle-invasive bladder cancer (NMIBC / MIBC)](https://onco.cc/terms/nmibc-vs-mibc/)
- trials: [A Study of TAR-200 Versus Intravesical Chemotherapy in Participants With Recurrent High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC) After Bacillus Calmette-Guérin (BCG)](https://onco.cc/trials/nct06211764/), [A Trial to Evaluate Intravesical Nadofaragene Firadenovec Alone or in Combination With Chemotherapy or Immunotherapy in Participants With High-grade BCG Unresponsive Non-muscle Invasive Bladder Cancer](https://onco.cc/trials/nct06545955/), [SunRISe-1](https://onco.cc/trials/sunrise-1/), [Trial of Nadofaragene Firadenovec vs. Observation in Participants With Intermediate Risk Non-Muscle Invasive Bladder Cancer](https://onco.cc/trials/nct06510374/)
- technologies: [Trained innate immunity](https://onco.cc/technologies/trained-innate-immunity/)
- ideas: [Engineered bacteria that live in tumours and manufacture drugs there](https://onco.cc/ideas/idea-bio2-engineered-bacteria-payloads/), [Train the bone marrow to make better anti-tumour immune cells](https://onco.cc/ideas/idea-bio2-trained-immunity-priming/)
- pathways: [Myeloid suppression: TAMs, MDSCs & don't-eat-me signals](https://onco.cc/pathways/myeloid-suppression-axis/)
- roadmaps: [Devices and physical therapies roadmap: heat and light → electric fields and focused sound → drug-releasing implants](https://onco.cc/roadmaps/devices-roadmap/)
- companies: [Endo (now Keenova Therapeutics and Par Health)](https://onco.cc/companies/endo/)

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