Bladder cancer is a malignant growth arising in the urinary bladder, most commonly from urothelial cells. It can present as non-muscle-invasive, muscle-invasive, or metastatic disease and often first appears with hematuria.
Moderna and Merck's personalized mRNA cancer vaccine, intismeran autogene, showed promising Phase 3 results in preventing melanoma recurrence. Combined with Keytruda, it cut recurrence risk by half and reduced spread by 59% in earlier data. The treatment could reach patients within two years pending regulatory approval.
Merck and Moderna's personalized mRNA cancer vaccine combined with Keytruda significantly reduced melanoma recurrence risk in a Phase 3 trial. The FDA has not yet approved the vaccine, with potential availability expected by early 2027.
Recent studies on mRNA COVID-19 vaccines reveal spike protein and mRNA persistence beyond 3.5 years, no brain changes on MRI in healthy adults, and stress responses in heart cells in vitro.
KEYNOTE-942 five-year data: intismeran autogene plus Keytruda reduced melanoma recurrence risk by 49% and kept 68.8% of patients cancer-free versus 49.1% with Keytruda alone. Distant metastasis or death risk fell 59%.
The FDA approved six cancer therapies in Q2 2026, including first-line sacituzumab govitecan for triple-negative breast cancer and capivasertib for PTEN-deficient prostate cancer. A separate study shows 69% of accelerated-approval cancer drugs need safety updates within 4 years.
The bladder cancer therapeutics market is expanding with recent FDA approvals including INLEXZO for NMIBC and a KEYTRUDA-Padvev combination for MIBC, while the NMIBC market reached approximately USD 3 billion in 2025 across seven major markets. Ferring reported record revenues exceeding €2.5 billion in 2025, driven by Adstiladrin as its second major growth driver. A robust pipeline of emerging therapies is expected to further transform the market through 2036.
Clinical trial results support ctDNA-guided therapy for bladder cancer, with the phase III IMvigor011 trial showing improved survival outcomes. Standardisation efforts are underway through position papers from professional societies and consensus guidelines. Nanotechnology advances and AI integration are poised to improve ctDNA detection sensitivity for liquid biopsy applications.
Tempus has launched "Preview," an AI-powered tool that provides early cancer insights within one day of sample receipt to inform treatment planning. The tool focuses on high-impact biomarkers including MSI-H, EGFR mutations, and FGFR fusions across several cancer types. The launch aligns with expert emphasis on the critical role of early biomarker testing in personalizing therapy for EGFR-mutated NSCLC.
ImmunityBio said the FDA accepted its sBLA for ANKTIVA plus BCG in BCG-unresponsive non-muscle invasive bladder cancer with papillary disease. The PDUFA date is Jan. 6, 2027.
ImmunityBio said the Saudi FDA encouraged submission of a regulatory package for recombinant BCG and opened talks on expanding ANKTIVA with checkpoint inhibitors to additional tumor types. The company expects to file the rBCG package within weeks.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07782164 |
Efficacy of Irreversible Electroporation (IRE) for Treating Recurrent Pelvic Tumors (PELFIRE Study) |
RECRUITING | |
| NCT07781852 |
Evaluation of the Distribution of 64Cu/68Ga Labeled CM500 in Healthy Volunteers and Patients With Cancer |
NOT_YET_RECRUITING | EARLY_PHASE1 |
| NCT07762820 |
REtrieval of Transurethrally Resected Intact En-bloc Vesical Tumors Using a Retrieval Device for Bladder Tumors |
NOT_YET_RECRUITING | NA |
| NCT07762586 |
Luminal Bladder Cancer Effective Response to Neoadjuvant Chemotherapy (LUMBER-NAC) |
RECRUITING | PHASE2 |
| NCT07756008 |
Bladder-Sparing Treatment With Disitamab Vedotin and Toripalimab With or Without Pelvic Lymph Node Dissection in Bladder Cancer |
NOT_YET_RECRUITING | PHASE2/PHASE3 |
| NCT07749924 |
Active Surveillance Versus Adjuvant Intravesical Chemotherapy in Liquid Biopsy-Defined Low-Shedding Intermediate-Risk NMIBC |
NOT_YET_RECRUITING | NA |
| NCT07735858 |
Microfluidic Urinary Exosome-Based Diagnostic Model for Bladder Cancer |
ACTIVE_NOT_RECRUITING | |
| NCT07732686 |
Analysis of Breath Volatile Organic Compounds Using Mass Spectrometry |
NOT_YET_RECRUITING | |
| NCT07727343 |
AI-Guided TURBT for Bladder Cancer |
NOT_YET_RECRUITING | NA |
| NCT07724886 |
Role of ERBT Plus Intravesical BCG in Intermediate-Risk or High-Risk NMBC |
NOT_YET_RECRUITING | NA |
