Fast Track Designation for Pelareorep in 2L+ Anal Cancer
“This Fast Track designation represents another important regulatory milestone for Oncolytics and reflects the significant progress we have made over the past twelve months in advancing pelareorep toward potential registration,” said Jared Kelly, Chief Executive Officer of Oncolytics. “During that time, we have received Fast Track designation in both metastatic colorectal cancer and squamous cell anal carcinoma, achieved important FDA alignment on registrational development strategies, strengthened our intellectual property portfolio, and continued to generate compelling clinical data across our gastrointestinal oncology programs. Our April meeting with the FDA provided important clarity regarding a potential registrational pathway for pelareorep in second-line and later anal cancer, reinforcing our confidence in the program and our strategy to address an area of significant unmet need. We believe these milestones continue to de-risk our development programs while positioning the Company to deliver meaningful value for patients and shareholders.”
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