Anal cancer is a malignant tumor that develops in tissues of the anus or anal canal. Most cases are squamous cell carcinomas and are frequently associated with persistent HPV infection.
The FDA granted Fast Track designation to Oncolytics Biotech's pelareorep combined with a checkpoint inhibitor for advanced squamous cell carcinoma of the anal canal. The designation follows encouraging GOBLET study data and supports development in an estimated $1 billion market with no approved therapies.
Cancer care is being transformed by targeted therapy, immunotherapy, personalized medicine, and emerging mRNA-based universal cancer vaccines. Advances in immunotherapeutics and cellular therapies are improving survival rates, while an off-the-shelf mRNA vaccine from the University of Florida is already in human trials.
A cost-effectiveness analysis found home-based anal cancer screening increased participation versus clinic-based screening among sexual and gender minority individuals. The approach remained investigational because the FDA has not approved self-sampling for anal cancer screening.
Oncolytics Biotech received FDA Fast Track Designation for pelareorep in KRAS-mutant colorectal cancer based on data showing 33% response rate and 27-month median survival. The company is launching a Phase 2 study and recently completed reincorporation from Canada to Nevada. This marks the second Fast Track Designation for pelareorep in gastrointestinal cancers.
Incyte received a Complete Response Letter from the FDA for Zynyz in lung cancer due to third-party manufacturing issues, while the EMA recommended approval for the drug in anal cancer treatment based on Phase 3 trial data.
The immuno-oncology market is projected to grow from $65.22 billion in 2025 to $170.19 billion by 2032, driven by checkpoint inhibitors, CAR-T cell therapy, and cancer vaccines, with North America commanding 43% market share.
Oncolytics Biotech launches Phase 2 trial of pelareorep immunotherapy in metastatic colorectal cancer, following Fast Track Designation and promising earlier results showing 27-month median survival.
Oncolytics Biotech received FDA Fast Track Designation for pelareorep in second-line KRAS-mutant microsatellite-stable metastatic colorectal cancer, based on clinical data showing a 33% response rate and median overall survival of 27 months versus 11.2 months with standard treatment.
Oncolytics Biotech received FDA Fast Track Designation for pelareorep in second-line KRAS-mutant microsatellite-stable metastatic colorectal cancer, based on clinical data showing a 33% response rate and median survival of 27 months versus 11.2 months with standard treatment.
Oncolytics Biotech announced FDA Fast Track Designation for pelareorep combined with bevacizumab and FOLFIRI for second-line treatment of KRAS-mutant metastatic colorectal cancer, driving shares up 19.7%.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07782164 |
Efficacy of Irreversible Electroporation (IRE) for Treating Recurrent Pelvic Tumors (PELFIRE Study) |
RECRUITING | |
| NCT07775209 |
Shortening Radiation Course Duration Using Simultaneous Integrated Boost With Lower Intensity Elective Nodal Dosing and Concurrent Chemotherapy for High-Risk Anal Squamous Cell Carcinoma |
NOT_YET_RECRUITING | PHASE2 |
| NCT07696169 |
Disease Evolution and Risk Factors of AIDS-related Prevalent Cancers |
NOT_YET_RECRUITING | |
| NCT07668284 |
COQ10 and Vitamin E for Off-Target Radiation Toxicity |
NOT_YET_RECRUITING | PHASE1/PHASE2 |
| NCT07523152 |
Assessment of Sexual Quality of Life Following Local Treatment (Radiotherapy With or Without Surgery) in Patients With HPV-positive Pelvic Cancer: a Descriptive Longitudinal Study |
NOT_YET_RECRUITING | NA |
| NCT07425054 |
ctHPVDNA Response-Adapted Chemoradiation +/- Retifanlimab Treatment in Locally-Advanced Anal Cancer |
RECRUITING | PHASE2 |
| NCT07296237 |
Beyond Survival: Addressing Gynecological and Sexual Health in Women After Radiotherapy for Anal Cancer |
RECRUITING | |
| NCT07192055 |
Self-sampling to Optimize Anal Lesion Outcomes |
RECRUITING | NA |
| NCT07124000 |
DESTINY-PANTUMOUR04 |
RECRUITING | |
| NCT07090174 |
CASCADE: Testing for Safety and Immune Effects of PDS0101, an Anti-HPV Therapy, Among People Living With HIV |
WITHDRAWN | PHASE2 |
