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.
ImmunityBio reported a fivefold revenue increase to $38.29 million, driven by a 750% surge in unit sales of its cancer drug Anktiva. The company is expanding internationally through partnerships in the Middle East and preparing additional FDA submissions for Anktiva's broader use.
ImmunityBio has partnered with Accord Healthcare to expand access to Anktiva across 30 countries following conditional EU authorization. The company established an Irish subsidiary to support European distribution and commercialization.
The European Commission granted conditional marketing authorization for ANKTIVA in combination with BCG for BCG-unresponsive non-muscle invasive bladder cancer, expanding the therapy's availability to 33 countries across four regulatory jurisdictions.
Moderna and Merck announced median five-year follow-up data showing intismeran autogene in combination with Keytruda reduced the risk of melanoma recurrence or death by 49% in high-risk patients following complete resection.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07347132 |
Comparison of Pathological Outcome and Recurrence Rate Between En Bloc and Conventional Transurethral Resection of Bladder Tumor |
COMPLETED | NA |
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The Role of Universal Cancer Only Marker SIX6 in Diagnosing Non-Muscle Invasive Bladder Cancer |
ACTIVE_NOT_RECRUITING | NA |
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A Study to Learn About the Study Medicine PF-08052667 in People With Bladder Cancer |
RECRUITING | PHASE1 |
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Exploration of Novel AI-enabled Blue Light Enhanced Cystoscopy |
RECRUITING | |
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Radiotherapy for BCG-unresponsive Non-muscle-invasive Carcinoma in Situ (CIS) Bladder Cancer: an Open-label, Single-arm, Multicentre, Phase 2 Study |
NOT_YET_RECRUITING | NA |
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A Study Comparing Standard Treatments in People With Non-Muscle Invasive Bladder Cancer (NMIBC) |
RECRUITING | PHASE3 |
| NCT06816017 |
A Study to Evaluate Eciskafusp Alfa in Combination With Bacillus Calmette-guerin (BCG) in Participants With BCG-unresponsive High-risk Non-muscle Invasive Bladder Cancer (NMIBC) |
WITHDRAWN | PHASE1 |
| NCT06781879 |
Chemoablation Or Bladder Resection With Adjuvant Chemotherapy in Recurrent Non-Muscle Invasive Bladder Cancer |
RECRUITING | PHASE4 |
| NCT06637423 |
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Patients With Bladder Cancer (MK-2870-027) |
RECRUITING | PHASE1/PHASE2 |
| NCT06632964 |
A Clinical Trial Aimed At Assessing the Efficacy and Safety of VT-101 for the Treatment of Non-muscle Invasive Bladder Cancer |
RECRUITING | PHASE1 |
