valrubicin / Generic mfg. - LARVOL DELTA

Cost per Responder of TAR-200 vs. Other FDA-Approved Novel and Generic Treatments Among Bacillus Calmette-Guérin-Unresponsive High-Risk Non-Muscle Invasive Bladder Cancer With Carcinoma in Situ in the United States (ISPOR-EU 2025) - "Patients treated with TAR-200 monotherapy were compared to those treated with pembrolizumab, nadofaragene firadenovec (NF), nogapendekin alfa inbakicept (NAI)+BCG (with and without reinduction), or valrubicin based on published clinical trial data. TAR-200 demonstrated the highest proportion of patients achieving and sustaining CR for ≥12 months, translating to substantial cost savings per responder compared to other FDA-approved treatments for BCG-UR HR-NMIBC with CIS."

Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Host-Guest Complexes of Cucurbituril with the neutral Guest Valrubicin: An Experimental and Computational Study. (PubMed, Drug Dev Ind Pharm) - "IntroductionValrubicin (VAL) is an N-trifluoroacetyl 14-valerate derivative of the anthracycline doxorubicin (DOX)and is known to have anti-tumor activity. The VAL-CB [7, 8] complex exhibited a 220,000-fold solubility increase, enhanced stability, and a sustained release profile.ConclusionThe CB-VAL complex significantly enhanced physicochemical properties of VAL in aqueous solutions, with superiority for CB8. These results highlight the potential of CB7 and CB8 as novel drug delivery systems for hydrophobic drugs, offering a strategy to overcome the limitations of existing solubilization approaches in cancer therapy."

Journal • Oncology

Long-term outcomes of a cascading salvage strategy for high-risk non-muscle-invasive bladder cancer. (PubMed, BJU Int) - "Multi-line BST is feasible and can yield durable bladder preservation and oncological control in select patients with HR-NMIBC following BCG failure. Progression-free outcomes remained favourable across successive lines of salvage therapy. These findings support the role of longitudinal BST as an alternative to radical cystectomy in carefully and appropriately selected patients."

Journal • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Necrotizing Sialometaplasia of Tubarial Glands With Rouvière Lymphadenitis Complicating Postradiotherapy Tumor Follow Up. (PubMed, Laryngoscope) - "Tubarial gland location is shown in D (original scheme from Valstar, Matthijs, et al. Radiotherapy and Oncology, 154, 292-298: with permission)."

Journal • Oncology

Extended Outcomes of Intravesical Valrubicin and Docetaxel as a Secondary Salvage Treatment for Recalcitrant High-risk Non-muscle-invasive Bladder Cancer. (PubMed, Eur Urol Focus) - "Val/Doce was safe and efficacious in patients with recurrent HR-NMIBC. The capacity to delay progression and avoid RC in a significant proportion of patients highlights its potential as a valuable treatment option in this challenging clinical context and warrants prospective evaluation."

Journal • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

Treatment patterns and clinical outcomes in patients with high-risk BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ (AUA 2025) - "A majority (70%) of these patients received intravesical chemotherapy (specifically 30% gemcitabine, 46% mitomycin, 11% gemcitabine-docetaxel, 12% valrubicin), while 17% underwent radical cystectomy (Figure 1). Despite the recommended standard of care being radical cystectomy, analyses using real-world data from the AQUA Registry demonstrated that most patients initiated intravesical chemotherapy within one year of adequate BCG. Furthermore, the intravesical therapies did not provide durable responses, demonstrating the unmet need for innovative bladder-sparing treatments in this patient population."

Clinical • Clinical data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urology

NAT2 activity increases cytotoxicity of anthracycline antibiotics and HDAC inhibitors. (PubMed, Biochim Biophys Acta Mol Basis Dis) - "Among those 147 drugs we found doxorubicin, daunorubicin, epirubicin, valrubicin, teniposide, afatinib, carmustine, vincristine, panobinostat, and vorinostat to have increased toxicity to cancer cells expressing the rapid NAT2 allele. Additionally, we report NAT2-mediated acetylation of idarubicin, daunorubicin, doxorubicin, vorinostat, and CUDC-101. These findings have implications for pharmacogenomics and cancer precision medicine using conventional chemotherapeutic drugs, as improving their efficacy and safety may affect >4 million cancer patients worldwide that receive these drugs as standard of care."

Journal • Oncology • NAT2

Real-World Treatment Patterns and Outcomes in Patients With Bacillus Calmette-Guérin-Unresponsive High-Risk Non-Muscle-Invasive Bladder Cancer: A Multicountry Medical Chart Review. (PubMed, Clin Genitourin Cancer) - "After BCG-unresponsive disease, most patients with high-risk NMIBC received BCG rechallenge with or without other therapies, and > 25% experienced disease progression within the first 3 years. Effective bladder-sparing options for BCG-unresponsive NMIBC are needed."

HEOR • Journal • Real-world evidence • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

Multidrug micelles and sonopermeation for chemotherapy co-delivery to brain tumors. (PubMed, J Control Release) - "Via high-throughput screening of various chemotherapy combinations in different glioma cell lines, valrubicin and panobinostat were identified as a synergic drug combination and co-loaded in mPEG-b-p(HPMAm-Bz)-based polymeric micelles. In orthotopically inoculated patient-derived HSJD-DIPG-007 diffuse intrinsic pontine gliomas, notoriously known to have an intact BBB and poor drug responsiveness, we provide initial experimental evidence showing that multidrug micelles plus sonopermeation can help to improve treatment efficacy. Our work exemplifies that synergistic drug combinations can be efficiently co-loaded in polymeric micelles, and that advanced nanosonochemotherapy combination regimens hold promise for the treatment of hard-to-treat brain cancers."

Journal • Brain Cancer • CNS Tumor • Diffuse Intrinsic Pontine Glioma • Glioma • Oncology • Solid Tumor

Bacillus Calmette-Guérin (BCG) Refractory Non-Muscle-Invasive Bladder Cancer (NMIBC): Current Guidance and Experience from Clinical Practice. (PubMed, Res Rep Urol) - "However, systemic immunotherapy with pembrolizumab or gene therapy with intravesical nadofaragene firadenovec may be administered for patients unfit or unwilling to undergo radical cystectomy with outcomes superior to intravesical docetaxel, gemcitabine or valrubicin. The last years have been exciting regarding new developments in this field after a long period of stagnation. Unfortunately, data available on some alternative therapies are mainly limited mainly to Phase I or II studies with a lack of robust evidence, but a clear trend in future treatments has just been drawn."

Journal • Review • Bladder Cancer • Gene Therapies • Genito-urinary Cancer • Oncology • Solid Tumor

Chemoresistance-Motility Signature of Molecular Evolution to Chemotherapy in Non-Muscle-Invasive Bladder Cancer and Its Clinical Implications. (PubMed, Cancer Lett) - "In addition, we identified five drugs that can be used with gemcitabine in these patients, including doxorubicin, docetaxel, paclitaxel, napabucacin, and valrubicin, and verified their efficacy. The CrM signature can assess NMIBC prognosis and BCG treatment response, suggesting alternative treatments. Furthermore, these results need to be prospectively validated."

Journal • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urology • CAFs • TGFB1

Evidence is not sufficient to declare the tubal gland conglomerates as salivary. (PubMed, Radiother Oncol) - "The letter to Editor is regarding an article by Pringle et al., 2023 which presents the histological and immunohistochemical characterization of the submucosal seromucous gland conglomerate at the nasopharyngeal end of the auditory tube (AT) and compares the same with the major and minor salivary glands, while trying to substantiate the claims of a previous work by Valstar et al., 2021...They mentioned that AT glands are "taxonomically different from the salivary glands" based on their anatomical location along the respiratory tract, the overlying mucosa lined with respirator yepithelium, and the absence of enzyme salivary amylase. This letter presents data from the already existing literature to emphasise the fact that the evidence given by Pringle et al., 2023 are not sufficient to declare the tubal gland conglomerates as salivary."

Journal

Repurposing Valrubicin as a Potent Inhibitor of Ovarian Cancer Cell Growth. (PubMed, Anticancer Res) - "Valrubicin, through drug repositioning, can be applied as a new therapeutic agent for OC."

Journal • Oncology • Ovarian Cancer • Solid Tumor • CASP3

Identification of novel anti-leishmanials targeting glutathione synthetase of the parasite: a drug repurposing approach. (PubMed, FEBS Lett) - "Here, we evaluated four FDA-approved drugs-valrubicin, ciclesonide, deflazacort, and telithromycin-for their anti-leishmanial activity on Leishmania donovani parasites, especially their ability to target the enzyme glutathione synthetase (LdGS), which enables parasite survival under oxidative stress in host macrophages. Subsequent testing on amastigotes revealed the IC50 values of 1.74 ± 0.05 μm and 3.32 ± 0.21 μm for valrubicin and ciclesonide, respectively. Molecular and cellular level analysis further elucidated the mechanisms underlying the anti-leishmanial activity of valrubicin and ciclesonide."

Journal • Infectious Disease

Integrating network analysis with differential expression to uncover therapeutic and prognostic biomarkers in esophageal squamous cell carcinoma. (PubMed, Front Mol Biosci) - "We also identify the molecules targeting these essential hub genes, among which GSK461364 is a promising inhibitor of PLK1, BMS265246, and Valrubicin inhibitors of CDK1 and TOP2A, respectively. Notably, MMP9 emerged as a significant prognostic marker with high expression correlating with poor survival, underscoring its potential for targeted therapy. These findings enhance our understanding of ESCC pathogenesis and highlight promising avenues for treatment."

Biomarker • Journal • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastrointestinal Cancer • Oncology • Squamous Cell Carcinoma • CDK1 • MAD2L1 • MMP9 • PLK1 • TOP2A

New Intravesical Agents for BCG-Unresponsive High-Risk Non-Muscle Invasive Bladder Cancer. (PubMed, Bladder Cancer) - "Considering the plethora of novel intravesical treatments that have completed phase II evaluation, one can reasonably expect that clinicians will soon have at their disposal new agents and treatment options for BCG-unresponsive NMIBC. In the near future, it will be up to the urologist to identify, for each specific patient, the right agent to use, based on safety, results and cost-effectiveness."

Journal • Review • Bladder Cancer • Gene Therapies • Genito-urinary Cancer • Oncology • Solid Tumor • Urology

Comparative analysis of adverse events among intravesical drugs in bladder cancer: a real-world study on FAERS database. (PubMed, Expert Opin Drug Saf) - "We elucidated all signals compared with the overall FAERS database or other administration routes for Bacillus Calmette-Guerin (BCG), mitomycin, gemcitabine, valrubicin, and epirubicin. We have compiled an overview of the AEs tied to intravesical drugs whilst considering their individual distinctions. These insightful findings serve to enrich our comprehension of the safety profiles and potential risks linked to intravesical therapy."

Adverse events • Journal • Real-world • Real-world evidence • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Guideline for RSA and CT-RSA implant migration measurements: an update of standardizations and recommendations. (PubMed, Acta Orthop) - "They were approved in December 2023 by the board and selected members of the International Radiostereometry Society to update the guidelines by Valstar et al...Both authors and reviewers of scientific papers using RSA may use these guidelines, summarized in the Checklist, as a reference. Deviations from these guidelines should have the underlying rationale stated."

Journal

Early experience with sequential intravesical gemcitabine and docetaxel for micropapillary variant non-muscle invasive bladder cancer. (PubMed, Urol Oncol) - "Gem/Doce with Val/Doce rescue appears to have activity against carefully selected non-muscle invasive MPUC with favorable histology. Larger prospective trials are needed to validate these results."

Journal • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

Valrubicin-loaded immunoliposomes for specific vesicle-mediated cell death in the treatment of hematological cancers. (PubMed, Cell Death Dis) - "We created valrubicin-loaded immunoliposomes (Val-ILs) using the antitumor prodrug valrubicin, a hydrophobic analog of daunorubicin. This study provides a promising preclinical demonstration of the effectiveness and ease of preparation of Val-ILs as a novel nanoparticle technology. In the context of hematological cancers, Val-ILs have the potential to be used as a precise and effective therapy based on targeted vesicle-mediated cell death."

Journal • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • B Acute Lymphoblastic Leukemia • Bone Marrow Transplantation • Hematological Disorders • Hematological Malignancies • Leukemia • Lymphoma • Oncology • Pediatrics • T Acute Lymphoblastic Leukemia • Transplantation • CD33 • CD34 • CD7 • ITGAM • LAG3

Survey on clinical practice patterns in the united states for using intravesical chemotherapy in the management of bacillus calmette-guérin unresponsive non-muscle invasive bladder cancer (AUA 2024) - "40% Gemcitabine (Gem), 28% Mitomycin-C (MMC), 19% Valrubicin (Val), 8% Gemcitabine/Docetaxel (Gem/Doce), and 5% others were the rank order for CIS patients with adequate BCG. This recent poll of US urologists revealed that intravesical single-agent chemotherapy was the most often recommended treatment for BCG-unresponsive NMIBC, with Gem or MMC making up about 70% of the chemotherapy regimens. Whether therapy was for papillary-only or CIS tumors, regardless of BCG exposure, this practice pattern remained consistent."

Clinical • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urology

OPTIMIZING AN ORGANOID ASSAY FOR PREDICTING INTRAVESICAL THERAPY RESPONSE IN LOW-GRADE INTERMEDIATE RISK NON-MUSCLE INVASIVE BLADDER CANCER (AUA 2024) - "On Day 1, a selection of IVT were added to PDOs as monotherapies in serial dilutions: cisplatin, gemcitabine, docetaxel, cabazitaxel, mitomycin C (MMC), and valrubicin. This PDO assay can identify the most effective IVT in vitro within a clinically relevant time frame. In multiple patients, the assay-determined most effective IVT would have changed clinical management. Further optimization and implementation of this assay as a corollary in clinical trials could be used to glean meaningful insights into mechanisms of sensitivity and resistance."

Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

PELP1 inhibition enhances the therapeutic efficacy of topoisomerase inhibitors in triple-negative breast cancer (AACR 2024) - "Of the five drugs, the three drugs Gemcitabine, Valrubicin, and Mitoxantrone, induced DNA damage by inhibiting topoisomerase, a protein that cleaves and reconnects DNA during replication. Together, these results suggest a novel targeted therapy for the treatment of TNBC, involving the combination of topoisomerase inhibitors and the PELP1 inhibitor SMIP34."

Clinical • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ANXA5 • PELP1 • TOP2A

Patient-derived model systems of endometrial cancers for disease modeling and drug sensitivity testing (AACR 2024) - "The drug screening results clearly highlighted several standout drugs, including CUDC-907 (a dual PI3K/HDAC inhibitor), two histone deacetylase (HDAC) inhibitors including romidepsin and panobinostat, four topoisomerase II (TOP II) inhibitors including mitoxantrone, daunorubicin, doxorubicin, and epirubicin, two proteasome inhibitors including carfilzomib and bortezomib, 2 DNA-directed RNA synthesis inhibitor dactinomycin and plicamycin, omacetaxine mepesuccinate (protein synthesis inhibitor), and valrubicin (DNA synthesis inhibitor). Our unique PDXs and PDCs are excellent models for representing various characteristics of EC and testing novel therapeutics. This current study presents a promising direction for developing personalized therapy options for EC patients and provides a platform for further investigation of drug mechanisms and tumor development. Future studies will also involve etiology, such as chronic psychological stress, DNAm age and intratumoral microbiome."

Clinical • Colorectal Cancer • Endometrial Cancer • Gynecologic Cancers • Oncology • Solid Tumor

Patterns of treatment of high-risk BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) patients among Arab urologists. (PubMed, Arch Ital Urol Androl) - "Even though Arab urologists are in the majority of cases selecting RC for BCG-unresponsive cases, one-third of them are most recently initiating intravesical chemotherapy as an alternative option. To further assist Arab urologists in the appropriate selection of BCG unresponsive high risk NMIBC patient treatments, enhanced education and pathway protocols are needed."

Journal • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urology