# Valrubicin

Source: https://onco.cc/drugs/valrubicin/  
OnCo record `valrubicin` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Valrubicin (Valstar) is a chemotherapy washed into the bladder for carcinoma in situ that has not responded to BCG, in patients who cannot yet have their bladder removed.

## Summary

Valrubicin was approved in September 1998 for intravesical therapy of BCG-refractory carcinoma in situ of the urinary bladder in patients for whom immediate cystectomy would carry unacceptable morbidity or mortality. In the pivotal experience, 230 patients received the drug and about one in five with refractory CIS had a complete response, mostly not durable, so it is a bridge rather than a cure; the label stresses that delaying cystectomy risks progression. Newer options for BCG-unresponsive disease (pembrolizumab, nadofaragene firadenovec, nogapendekin alfa inbakicept, TAR-200) have reduced its use. Irritative bladder symptoms and red-tinged urine are expected.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-10
- Tags: nci-list
- Brand: Valstar
- Modality: Anthracycline (intravesical)
- Mechanism: Semi-synthetic anthracycline analogue of doxorubicin instilled into the bladder; inhibits nucleoside incorporation into nucleic acids and topoisomerase II, arresting cells in G2.
- Approvals: US 1998: Intravesical therapy of BCG-refractory carcinoma in situ of the bladder when immediate cystectomy is not acceptable

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Valrubicin
- US label (DailyMed): https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=valrubicin
- NCI drug page: https://www.cancer.gov/about-cancer/treatment/drugs/valrubicin

## Connected records

- drugs: [Nadofaragene firadenovec](https://onco.cc/drugs/nadofaragene-firadenovec/), [Nogapendekin alfa inbakicept](https://onco.cc/drugs/nogapendekin-alfa/)
- cancers: [Bladder & urothelial cancer](https://onco.cc/cancers/urothelial/)
- technologies: [Intravesical therapy (BCG, chemotherapy, devices, gene and viral therapy)](https://onco.cc/technologies/bcg-and-intravesical-therapy/), [Topoisomerase-I inhibitors (and ADC payloads)](https://onco.cc/technologies/topoisomerase-inhibitors/)
- companies: [Endo (now Keenova Therapeutics and Par Health)](https://onco.cc/companies/endo/)
- trials: [Multi-center Study to Evaluate the Efficacy and Safety of Maintenance Therapy With Valrubicin Versus no Maintenance, in Subjects Treated With Valrubicin Induction for Carcinoma in Situ (CIS) of the Bladder](https://onco.cc/trials/nct01310803/)

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