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.
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.
FDA approves Genentech's Tecentriq as first ctDNA-guided adjuvant therapy for muscle-invasive bladder cancer, and Venclexta plus acalabrutinib as first all-oral fixed-duration regimen for CLL.
ImmunityBio has commercially launched ANKTIVA in Saudi Arabia for approved bladder and metastatic non-small cell lung cancer indications. The launch follows accelerated approval in lung cancer and extends the drug’s commercial rollout in MENA.
A study in Cell suggests a urine DNA test may help identify which people with non-muscle invasive bladder cancer are likely to benefit from BCG immunotherapy. The test detected minimal residual disease after surgery and BCG treatment and distinguished recurrence risk based on tumour DNA findings.
Samsung Bioepis plans to start a global Phase 1 trial of SBE303, its first independently developed new drug candidate targeting Nectin-4. Preclinical data showed tolerability up to 40 mg/kg in monkeys.
Durvalumab has been approved for rollout on the NHS for muscle-invasive bladder cancer. In a trial of more than 1,000 patients, it cut the risk of progression by 32% versus standard care.
The National Comprehensive Cancer Network has updated its bladder cancer guidelines to include ImmunityBio's Anktiva plus BCG for BCG-unresponsive papillary-only disease. The Category 2A recommendation expands treatment options beyond the drug's initial FDA approval for carcinoma in situ. ImmunityBio also announced its pivotal trial is adequately powered and European distribution partnerships to expand global access.
The phase 3 ENVISION trial shows 80% complete response rate for novel bladder cancer chemoablative therapy. AI integration accelerates precision oncology through biomarker identification and targeted treatments. OncoPRO real-time symptom monitoring system enhances patient safety and clinical trial data capture.
Merck will acquire Terns Pharmaceuticals for $6.7 billion to bolster its cancer pipeline ahead of Keytruda's 2028 patent expiration. The deal gives Merck access to TERN-701, an oral tyrosine kinase inhibitor for chronic myeloid leukemia. Merck projects over $70 billion in commercial opportunities from its pipeline by the mid-2030s.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07602010 |
Comparison of CT and MR (VI-RADS) Imaging for Local Bladder Cancer Staging |
RECRUITING | |
| NCT07581496 |
T1G3R-1 Trial: Detectability and Prognostic Value of ctDNA in T1 G3 Bladder Cancer |
RECRUITING | |
| NCT07568444 |
Enhancing Readability of Lay Abstracts and Summaries for Medical Knowledge Using Generative Artificial Intelligence (BRIDGE AI 3) |
COMPLETED | PHASE2 |
| NCT07545694 |
Study on the Effects of Drugs That Modulate the Endocannabinoid System on Spontaneous and Induced Contractility of the Human Detrusor Muscle |
RECRUITING | |
| NCT07525349 |
Immune-Stromal Landscape in Muscle-Invasive Bladder Cancer |
NOT_YET_RECRUITING | |
| NCT07514897 |
Detecting CREPT in Urine for Bladder Cancer Diagnosis and Monitoring |
RECRUITING | |
| NCT07510685 |
Closed-System Bladder Irrigation to Reduce Urinary Tract Infections After Endoscopic Urologic Surgery (IRIS Trial) |
COMPLETED | NA |
| NCT07492628 |
Dual-Target Nectin-4/HER2 CAR-NK Cells in Advanced Urothelial Carcinoma |
RECRUITING | PHASE1 |
| NCT07481123 |
COMPARISON OF OBTURATOR NERVE BLOCK TECHNIQUES IN TURBT |
COMPLETED | NA |
| NCT07475403 |
Urinary Tumor DNA-Guided Systemic Immunotherapy for Unresectable Very-High-Risk Non-Muscle-Invasive Bladder Cancer |
RECRUITING | PHASE2 |
